Trials Table

Here is my latest effort! I hope everything is correct — it’s a table that is meant to include all the clinical trials and high-quality retrospective and observational studies discussed on the site.
Each entry includes a link to the clinical trial (when available in the original article) as well as a link to the full article on the website.
The table can be sorted in ascending or descending order by any column (but I am still working on sorting the last 3 columns correctly).

If you’re viewing the table on a smartphone, turn your device to landscape orientation.

RPFS = radiographic progression-free survival; if an * is present, the result refers to some form of stratification (for example, the presence or absence of a genetic mutation, metastatic burden, etc.).
OS = overall survival, with the same note regarding the presence of an *.
PSA50 = percentage of patients who achieved at least a 50% decline in PSA. Same meaning of the * next to the number.

Please contact me if you encounter any issues while using or viewing the table. I will try to keep it updated!
NCT ID Stage Trial / Drug Phase rPFS (months) OS (months) PSA 50 (%)
NCT07359066 mCRPC SPR1020 / PARP1 inhibitor Next-generation selective PARP1 inhibitor designed to reduce blood count toxicity compared to olaparib. Targets HRR-deficient tumors (BRCA-mutated) and penetrates the brain. 1/2 n.a. n.a. n.a.
n.a. mCRPC GTB-5550 / B7-H3 TriKE Immunotherapy targeting B7-H3, highly expressed in advanced PCa. Uses TriKE technology to activate Natural Killer (NK) cells and IL-15 to sustain immune assault under hypoxia. 1 n.a. n.a. n.a.
NCT06784193 mCRPC UPDATE: OP-3136 / KAT6A/B inhibitor Epigenetic regulator targeting KAT6A/B. Specifically for mCRPC patients who failed standard therapies. Shows synergy when combined with docetaxel. 1 n.a. n.a. n.a.
n.a. mHSPC / mCRPC Alliance A222001 / Oxybutynin Repurposed bladder drug to manage ADT-induced hot flashes. High dose (5mg) achieved a 68% reduction in symptoms compared to placebo. 2 n.a. n.a. n.a.
NCT06616155 mCRPC JASPER / Ruxolitinib + Enzalutamide Targets the JAK/STAT inflammatory signaling axis to block lineage plasticity (AR-negative and neuroendocrine-like states) in AR-insensitive tumors. 1/2 n.a. n.a. n.a.
NCT07150715 mHSPC ANDROMEDA / 225Ac-PSMA-617 vs 177Lu-PSMA-617 Head-to-head trial of Alpha vs Beta PSMA therapy for oligorecurrent disease. Investigates if high-energy Alpha emission better eradicates microscopic metastases. 2 17.6* n.a. n.a.
NCT06966024 mCRPC DCC-2812 / GCN2 kinase activator Turns on the integrated stress response (ISR) via GCN2 kinase to overload cancer cells and trigger apoptosis. Useful for hormone-resistant tumors. 1 n.a. n.a. n.a.
NCT04633252 mCRPC PDS01ADC (M9241) + Docetaxel Immunocytokine IL-12 targeting necrotic tumor regions. Designed to boost the efficacy of docetaxel in heavily pretreated mCRPC populations. 1/2 9.6 n.a. 37.5
NCT07365995 mCRPC BNT324 (DB-1311) vs Docetaxel First-in-class B7-H3-targeting ADC. Data shows strong response rates even in patients who failed PARP inhibitors and Lu-177 PSMA therapy. 3 8.5* n.a. n.a.
n.a. mCRPC / NEPC SKL35501 / NTSR1-targeted Ac-225 Targeting Neurotensin Receptor 1 (NTSR1), which is enriched in PSMA-negative advanced disease and Neuroendocrine Prostate Cancer (NEPC). 1 n.a. n.a. n.a.
NCT07354594 mCRPC ARREST / 177Lu-PSMA + Radiotherapy boost Uses targeted external beam radiation to eliminate 'cold spots' missed by systemic Lu-177. Radiotherapy also supercharges PSMA expression on cancer cells. 2 n.a. n.a. n.a.
NCT06136650 mCRPC MK-5684-004 / Opevesostat CYP11A1 inhibitor blocking the first step of hormone production. Specifically targeted at patients with Androgen Receptor Ligand-Binding Domain (AR-LBD) mutations. 3 5* n.a. 73.7*
NCT07344311 mCRPC A-CAR032 / STEAP2 CAR-T Armored CAR-T cell therapy targeting STEAP2. Includes a shield to block immunosuppressive TGF-beta signals from the tumor microenvironment. 1 n.a. n.a. n.a.
NCT07341737 mCRPC SL-28 / Leukocyte-Tells Off-the-shelf donor cell therapy. A striking case study showed PSA reduction from 10.4 to 0.1 without requiring ADT-level testosterone suppression. 1/2 n.a. n.a. n.a.
n.a. mCRPC UPDATE: SECuRE / 67Cu-SAR-bisPSMA Copper-67 PSMA radioligand therapy. Demonstrated a 66.7% PSA50 response in heavily pretreated mCRPC patients with bone metastases. 2 n.a. n.a. 66.7
NCT06236139 mCRPC STEAP1 CAR-T + Enzalutamide Combines CAR-T cells targeting STEAP1 with Enzalutamide. Preclinical data showed complete disappearance of measurable disease in mouse models. 1 n.a. n.a. n.a.
NCT07336446 mCRPC ANDROMEDA / AZD9750 (AR PROTAC) Proteolysis-targeting chimera (PROTAC) that degrades the AR protein completely. Combined with Saruparib to exploit DNA repair vulnerabilities (BRCA/ATM). 1/2 n.a. n.a. n.a.
NCT07332455 mCRPC GSK5471713 / AR Degrader Small-molecule AR degrader aimed at overcoming resistance mechanisms like AR overexpression and splice variants by physically destroying the receptor. 1/2 n.a. n.a. n.a.
n.a. mCRPC (HRD+) BrUOG360 / Copanlisib + Rucaparib Targets concurrent HRD and PI3K pathway alterations. Investigates if PI3K inhibition can re-sensitize PARP-resistant tumors (BRCA1/2, PTEN loss). 1b/2 n.a. n.a. 23*
n.a. mCRPC UPDATE: PT-112 / Pyrophosphate Platinum Platinum-based agent with bone-seeking properties (osteotropism). Effective in neuroendocrine-like, AR-non-responsive end-stage disease. 3 n.a. n.a. n.a.
NCT07311694 mCRPC HRS-4357 / PSMA Radioligand Chinese randomized Phase 3 trial comparing new radioligand to NHA switching. Specifically for patients progresssed on exactly one prior ARPI. 3 n.a. n.a. n.a.
NCT07310433 mCRPC Dapagliflozin + NHA SGLT2 inhibitor (diabetes drug) used to block glucose uptake. Exploits the metabolic 'Warburg effect' vulnerability in castration-resistant cells. 2 n.a. n.a. n.a.
NCT07298239 mCRPC Allogeneic CAR-NK / PSMA target Off-the-shelf Natural Killer cells modified to target PSMA. Potentially faster and safer than patient-specific CAR-T therapies. 1 n.a. n.a. n.a.
NCT04887935 nmHSPC Dapagliflozin Neoadjuvant Pilot trial in high-risk localized PCa (before surgery). Measures impact on metabolic biomarkers (glucose, insulin) and tumor shrinkage. 1 n.a. n.a. n.a.
NCT07287150 mCRPC InavoPC / Inavolisib Ultra-selective PI3Kα inhibitor for patients with PTEN loss (40-60% of mCRPC). Blocks PI3K-AKT signals that drive resistance to hormonal therapy. 3 n.a. n.a. n.a.
NCT07288359 mCRPC GVV858 / CDK2 inhibitor Targeting the cell cycle in CCNE1-amplified tumors. Aims to block the 'escape route' tumors use when ADT fails to stop division. 1/2 n.a. n.a. n.a.
NCT07285694 mCRPC UPDATE: AB-3028 / Logic-gated CAR-T Programmable CAR-T cells requiring dual antigen recognition (PSMA + second priming antigen) to activate, reducing damage to healthy tissues. 1/2 n.a. n.a. n.a.
NCT06136884 mCRPC UPDATE: AO-252 / TACC3 inhibitor Brain-penetrating oral inhibitor of TACC3. Disrupts mitosis to cause tumor shrinkage (22% seen in early data). Active in p53-mutated tumors. 1 n.a. n.a. n.a.
NCT07277270 mCRPC GSK5764227 / B7-H3 ADC + Enzalutamide Combines AR blockade with cytotoxic delivery to B7-H3 positive cells. Aims to overcome resistance where B7-H3 correlates with poor prognosis. 1/2 n.a. n.a. n.a.
NCT07192120 mCRPC MHB048C / PSMA-Targeted ADC Antibody-drug conjugate delivering Topoisomerase I inhibitor directly to PSMA cells. Features a bystander effect for antigen-heterogeneous lesions. 1/2 n.a. n.a. n.a.
NCT07268794 mHSPC CONVERT-HB1 / Local + Systemic Therapy Tests local treatment of primary tumor in high-volume patients who respond deeply to systemic therapy (induction ADT/ARPI/Docetaxel). 2 n.a. n.a. n.a.
NCT04876651 mCRPC ProstACT Global / TLX591 Beta-emitting PSMA antibody (rosopatamab). Antibody size minimizes dry mouth side effects compared to small-molecule radioligands (Pluvicto). 3 n.a. n.a. n.a.
NCT07258407 mCRPC TD001 / PSMA ADC PSMA-directed ADC using Exatecan (Top1 inhibitor). Potentially effective in tumors with lower or heterogeneous PSMA expression. 1/2 n.a. n.a. n.a.
NCT05320406 mHSPC REVELUTION / Relugolix vs Leuprolide Prospective study showing relugolix (antagonist) causes significantly less coronary plaque progression than leuprolide (agonist) over 12 months. 2 n.a. n.a. n.a.
n.a. mCRPC ITC-6146RO / B7-H3 ADC Highly stable ADC targeting B7-H3. Uses OHPAS linker and duocarmycin payload to minimize premature toxic release in blood. 1 n.a. n.a. n.a.
NCT04471727 mCRPC / NEPC MK-6070 / DLL3 Trispecific T-Cell Engager Targets DLL3 on aggressive neuroendocrine tumors. Trispecific design binds DLL3, CD3, and albumin to extend half-life and trigger precise T-cell killing. 1/2 n.a. n.a. n.a.
NCT07252414 mCRPC UPDATE: GenSci143 / Bispecific ADC (B7-H3 + PSMA) Dual-target antibody-drug conjugate targeting B7-H3 and PSMA simultaneously to overcome tumor heterogeneity and resistance in advanced prostate cancer. 1 n.a. n.a. n.a.
NCT07250542 mCRPC Fasudil Hydrochloride + PD-1 Checkpoint Blockade ROCK inhibitor (Fasudil) used to normalize tumor vasculature and reduce hypoxia, potentially turning 'cold' prostate tumors into 'hot' ones responsive to PD-1 immunotherapy. 2 n.a. n.a. n.a.
NCT07244341 mCRPC Valemetostat + Darolutamide Dual EZH1/2 inhibitor combined with darolutamide. Targets epigenetic drivers (PRC2 complex) to overcome lineage plasticity and neuroendocrine differentiation. 1/2 n.a. n.a. n.a.
NCT07244393 mCRPC KEYNOTE-G28 / 177Lu-DGUL + Pembrolizumab Combination of PSMA radioligand and PD-1 inhibitor. 177Lu-DGUL induces immunogenic cell death, potentially priming the tumor for pembrolizumab’s immune boost. 1 n.a. n.a. 81*
n.a. mCRPC GTB-5550 / Tri-specific NK Cell Engager Engages B7-H3 and CD16 while delivering IL-15 directly to Natural Killer cells. Designed to maintain activity in immunosuppressive tumor niches. 1 n.a. n.a. n.a.
NCT07241416 mHSPC Rezvilutamide vs Enzalutamide Head-to-head Phase 3 trial comparing two next-gen AR antagonists. Rezvilutamide is designed to have lower brain penetration, potentially reducing fatigue and seizures. 3 n.a. n.a. n.a.
NCT07230106 mCRPC SHR3680 + HS-20093 + SHR2554 (Triplet Therapy) Combines AR antagonist, B7-H3 ADC, and EZH2 inhibitor. Targets androgen signaling, cytotoxic delivery, and epigenetic regulation simultaneously. 2 n.a. n.a. n.a.
n.a. mCRPC / nmHSPC RAD 402 / Terbium-161 KLK3 Antibody Targets KLK3 (PSA gene). Uses Terbium-161, which emits both beta and Auger electrons for short-range lethal energy against micrometastases. 1 n.a. n.a. n.a.
n.a. mCRPC EVOLUTION / 177Lu-PSMA + Ipilimumab/Nivolumab Tests if dual checkpoint blockade improves Pluvicto outcomes. 33% of patients were progression-free at 12 months in the combination arm vs 17% in monotherapy. 2 12* n.a. n.a.
NCT07226986 mCRPC AMO959 + Pluvicto + ARPI AMPK activator combined with Pluvicto and standard ARPI. Aims to disrupt cancer cell metabolism while delivering targeted radiation. 1b/2 n.a. n.a. n.a.
NCT07226713 mCRPC (Stat5+) POSTPONE / Pacritinib JAK2/IRAK1 inhibitor for patients with high nuclear Stat5 activation (>5% of cells). Targets a key resistance loop driven by AR signaling inhibitors. 2 n.a. n.a. n.a.
NCT07225946 mCRPC KLK2-PASenger / Pasritamig + Docetaxel Bispecific T-cell engager targeting KLK2 combined with chemotherapy. Uses intermittent dosing to preserve T-cell fitness and avoid exhaustion. 3 n.a. n.a. 40*
n.a. mCRPC GenSci143 / Bispecific ADC (B7-H3 + PSMA) Designed to overcome single-antigen loss or heterogeneity. Combines two validated prostate targets with a Topoisomerase I inhibitor payload. 1 n.a. n.a. n.a.
NCT07224009 mHSPC / mCRPC Low-Dose Naltrexone for ADT Fatigue Investigates if 3mg naltrexone reduces ADT-induced fatigue by modulating mitochondrial bioenergetics and reducing pro-inflammatory cytokines like IL-6. 2 n.a. n.a. n.a.
NCT07219147 mCRPC Pluvicto + Sipuleucel-T Sequential strategy using radioligand therapy to cause antigen release, followed by Sipuleucel-T to boost the specific immune response against PAP. 1 n.a. n.a. n.a.
NCT06800313 mCRPC UPDATE 2: HLD-0915 / RIPTAC Bifunctional molecule that binds AR and BRD4 to kill cancer cells. Preliminary data: 59% PSA50 response and 32% PSA90 response in heavily pretreated patients. 1/2 n.a. n.a. 59
n.a. nmHSPC EMBARK / Enzalutamide + ADT Final OS data for high-risk biochemical recurrence. Combo reduces death risk by 40% over 8 years compared to hormone therapy alone. 3 n.a. 96* n.a.
NCT05534646 mCRPC UPDATE: ENV-105 (Carutoximab) + Apalutamide CD105 antagonist targeting the microenvironment. Interim data: median PFS of 13 months, significantly better than standard 2nd/3rd line hormone therapies. 2 13 n.a. 77.7*
NCT06190899 mCRPC Gedatolisib + Darolutamide Dual PI3K/mTOR inhibitor + AR blocker. Early data shows 6-month rPFS rate of 66% in patients who failed prior AR pathway inhibitors. 1/2 6.5* n.a. n.a.
NCT05720130 mCRPC ADVC001 / Lead-212 Alpha Therapy PSMA-targeted Lead-212 isotope. 80% of patients achieved PSA50 response. Includes complete radiographic responses within weeks of starting. 2 n.a. n.a. 80
n.a. nmHSPC PRESTO / Apalutamide Intensification For biochemical relapse with rapid PSA doubling time. Adding apalutamide to ADT improved PSA-PFS from 20 to 25 months without delaying testosterone recovery. 3 25* n.a. n.a.
n.a. nmHSPC (Local/Advanced) ENZARAD / Enzalutamide Intensification Subgroup analysis shows enzalutamide + ADT + Radiation significantly improves MFS (87% vs 77%) only in node-positive (N1) disease. 3 n.a. 83* n.a.
n.a. mHSPC PSMAddition / Pluvicto + ADT + ARPI Pluvicto moved to frontline hormone-sensitive setting. Reduced progression risk by 28%. 57.1% achieved complete radiographic response. 3 n.a. n.a. n.a.
n.a. mCRPC AlphaBet / 177Lu-PSMA + 223Ra Dual radionuclide therapy targeting bone (Radium-223) and soft tissue (Lutetium-177). Over 50% PSA50 response rate in bone-dominant disease. 1/2 n.a. n.a. 50
n.a. mHSPC ARASAFE / Alternative Docetaxel Schedule Compares 50mg bi-weekly vs standard 75mg tri-weekly Docetaxel. Alternative schedule reduced severe neutropenia/death risk (24% vs 64%) with same efficacy. 3 43.7* n.a. n.a.
n.a. mCSPC / mCRPC PETRANHA / Saruparib (PARP1) Next-gen PARP1 inhibitor. 88.5% ORR in mCSPC. Benefits seen in both HRR-mutated and wild-type patients, with improved hematologic safety. 1/2 n.a. n.a. 83*
n.a. nmHSPC Co-PSMA / 64Cu-SAR-bisPSMA Copper-based PET tracer identified twice as many lesions as 68Ga standard due to longer half-life (12.7h) allowing for next-day imaging. 2 n.a. n.a. n.a.
NCT07216248 mHSPC PSA-Triggered Intermittent Therapy / Relugolix Tests intermittent ADT using Relugolix + ARPI. Therapy is paused when PSA < 0.2, aiming to reduce side effects like metabolic and sexual dysfunction. 2 n.a. n.a. n.a.
NCT07213674 mCRPC Xaluritamig (AMG 509) + Abiraterone Large Phase 3 trial for chemo-naive patients. Combines STEAP1-targeting bispecific engager with hormonal suppression (Abiraterone). 3 n.a. n.a. n.a.
NCT07214961 mCRPC ARTISAN / AB001 (Lead-212 Alpha Radioligand) Lead-212 isotope targeting PSMA. Fractionated dosing aimed at high localized energy delivery with reduced systemic side effects. 1 n.a. n.a. n.a.
NCT07206056 mCRPC Tulmimetostat + JSB462 (Luxdegalutamide) Combines EZH1/2 inhibitor with AR PROTAC. Targets both the epigenetic silencing and the physical degradation of mutated androgen receptors. 1/2 n.a. n.a. 43*
n.a. mCRPC UPDATE: VIR-5500 / Dual-Masked T-cell engager Utilizes XTEN masking to activate T-cells only in the tumor environment. PSA50 response achieved in 58% of patients, even those with high burden. 1 n.a. n.a. 58
n.a. mCSPC (HRR+) AMPLITUDE / Niraparib + Abiraterone Moves PARP inhibitors to first-line mCSPC for HRR-mutated patients. Reduced risk of progression or death by 48% in BRCA1/2 patients. 3 26* n.a. n.a.
n.a. mCRPC Cabazitaxel vs ARPI Switch Prospective Phase 2b for poor prognosis disease. Prior ARPI exposure predicted failure of ARPI switch, making Cabazitaxel a better choice in that setting. 2b n.a. 30.9* 47.2*
n.a. mHSPC (Oligorecurrent) LUNAR / 177Lu-PNT2002 + SBRT Phase 2 trial for oligorecurrent PCa. Combining PSMA radioligand therapy with SBRT more than doubled rPFS (17.6 vs 7.4 months) and delayed ADT by a year. 2 17.6 n.a. n.a.
n.a. mHSPC ASPIRE / Docetaxel + Apalutamide Large Phase 3 trial evaluating treatment intensification by adding docetaxel to apalutamide and ADT. Incorporates genetic profiling for TP53, PTEN, and RB1 mutations. 3 n.a. n.a. n.a.
n.a. mCRPC Phase 1 / 161Tb-PSMA First clinical results for Terbium-161 PSMA in patients who failed 177Lu-PSMA. Achieved 57% PSA50 response and objective imaging response in 57% of participants. 1 n.a. n.a. 57
n.a. mCRPC (Poly-metastatic) Combination ARSI + Denosumab + Radiotherapy Multi-modal approach for patients with high-volume bone disease (≥4 lesions). 85% achieved ≥90% PSA reduction and 50% achieved undetectable PSA. 2 n.a. n.a. 85
n.a. nmHSPC BALANCE / Apalutamide + Salvage Radiation Uses PAM50 genomic subtyping to identify Luminal B tumors. Subtype-specific benefit: 5-year MFS improved to 94.7% vs 81.8% in the control. 2 n.a. n.a. n.a.
NCT07192614 mCRPC ACTIVATED-4-PC / AZD6621 T-cell engager targeting STEAP2. Preferentially activates CD8+ killer T-cells over CD4+ cells to maximize cancer kill and reduce inflammatory cytokine release. 1/2 n.a. n.a. n.a.
NCT07190300 mHSPC TulmiSTAR-02 / Tulmimetostat + ARPI Combines EZH2 inhibitor with Darolutamide or Abiraterone. Targets epigenetic regulation to delay emergence of resistance in newly diagnosed metastatic disease. 1/2 n.a. n.a. n.a.
NCT07181161 mCRPC AZD0516 / STEAP2 ADC Antibody-drug conjugate targeting STEAP1/2. Paired with brain-penetrant PARP1 inhibitor (AZD9574) to exploit DNA repair mechanisms via synthetic lethality. 1/2a n.a. n.a. n.a.
NCT07179783 mCRPC / NEPC Sacituzumab Tirumotecan + Tagitanlimab ADC targeting Trop-2 combined with PD-L1 inhibitor. Focuses on aggressive variant PCa and neuroendocrine subtypes where standard hormone therapy fails. 2 n.a. n.a. n.a.
NCT07181473 mCRPC TJ101 / Bispecific ADC (EGFR + B7-H3) Dual-targeting ADC attacking EGFR and B7-H3 simultaneously. Designed for hormone-resistant cases where B7-H3 is abundant. 1 n.a. n.a. n.a.
n.a. nmHSPC OST-504 / Listeria-based Immunotherapy Uses a live attenuated Listeria vector to deliver 24 prostate-associated antigens. Aims to induce T-cell responses in biochemical recurrence patients. 1b n.a. n.a. n.a.
NCT07164794 mCRPC / NEPC Memantine / NMDA Receptor Antagonist Repurposed Alzheimer’s drug. Blocks NMDA receptors which fuel a 'glutamatergic signaling autocrine loop' driving aggressive neuroendocrine transformation. 2 n.a. n.a. n.a.
NCT07164443 mCRPC KLK2-comPAS / Pasritamig Phase 3 randomized trial comparing KLK2-targeting bispecific T-cell engager vs placebo in late-line mCRPC. Preliminary data: 40% PSA50 response. 3 8* n.a. 40
n.a. mCRPC AB001 / Lead-212 PSMA Alpha therapy Targets PSMA with short-lived isotope Lead-212. Preclinical data suggests stronger tumor control than Pluvicto (beta-emitter) when given in fractionated doses. 1 n.a. n.a. n.a.
NCT05547061 mCRPC UPDATE: 177Lu-DGUL South Korean PSMA radioligand. Achieved 35.9% ORR (RECIST) and 81% (PET). Significantly lower xerostomia (13.2% vs 38.8% for Pluvicto). 2 n.a. n.a. 81*
n.a. mCRPC Low-Dose Abiraterone (250mg) + Food Brazil study showing 250mg dose with a low-fat meal is as effective as 1000mg fasted. PSA50 response rate was 68.3% in earlier stage patients. 2 7.9 20.6 68.3*
n.a. mHSPC ARCHES (5-Year Follow-up) / Enzalutamide Updated data: Enzalutamide + ADT boosted overall survival by 30%. Benefit particularly strong for high-volume disease (median OS 7 years vs 4 years). 3 n.a. 84* n.a.
n.a. mCRPC ITC-6146RO / B7-H3 ADC ADC targeting B7-H3 with OHPAS linker and duocarmycin payload. Specifically designed to avoid off-target damage and liver toxicity. 1 n.a. n.a. n.a.
n.a. mCRPC (MMR-deficient) Anti-PD-L1 (Atezolizumab/Durvalumab) Specific for MMR-deficient/MSI-H prostate cancer (5% of cases). 60% achieved PSA50 reduction. Median OS reached 27 months in this subgroup. n.a. 7.7 27 60
NCT07142551 mHSPC SPIDERMAN / BAT + Darolutamide Bipolar Androgen Therapy (BAT) alternating high/low testosterone combined with darolutamide. Aims to extend hormone sensitivity and reduce side effects. 2 n.a. n.a. n.a.
NCT07140900 mHSPC Xaluritamig (AMG 509) + ARPI STEAP1-targeted immunotherapy moved to frontline hormone-sensitive setting. Evaluates synergy with Abiraterone and Darolutamide. 1 n.a. n.a. n.a.
NCT05396833 mCRPC (ATM mutant) Lartesertib + Tuvusertib Combines ATM and ATR inhibitors. Creates a 'double hit' on DNA repair systems, particularly effective in ATM-deficient tumors (20-30% of cases). 1 n.a. n.a. n.a.
NCT04543903 Localized / Metastatic Alpha DaRT / Radium-224 seeds Implanted seeds coated with Radium-224. Emits alpha particles with extremely short range (mm) for ultra-precise destruction of tumors while sparing rectum/bladder. Pilot n.a. n.a. n.a.
NCT07114601 mCRPC OMNIRAY / LY4257496 (GRPR Radioligand) Targets Gastrin-Releasing Peptide Receptor (GRPR). Potential option for PSMA-negative tumors or patients who previously failed Pluvicto. 1 n.a. n.a. n.a.
n.a. n.a. Fasting-Mimicking Diets (FMD) Compares high vs low protein plant-based fasting. Both induced autophagy and IGF-1 reduction (35%), but High Protein FMD better reduced visceral fat. n.a. n.a. n.a. n.a.
NCT06347705 mCRPC 2141-V11 / CD40 Agonist Enhanced CD40 agonist injected directly into tumors. Replaces tumor tissue with Tertiary Lymphoid Structures (TLS). Induced systemic responses in non-injected sites. 1/2 n.a. n.a. n.a.
n.a. mCRPC UPDATE: HLD-0915 / Fast Track RIPTAC molecule inducing proximity between AR and an effector protein. Granted FDA Fast Track for advanced cases with emerged resistance. 1/2 n.a. n.a. 59
NCT06172283 mHSPC / nmHSPC Intermittent Fasting Adjuvant Tests if alternate-day fasting increases enzalutamide efficacy. Preclinical models showed 85% reduction in lesions and decreased tumor protein synthesis. 1/2 n.a. n.a. n.a.
NCT07111507 NEPC Tarlatamab / DLL3 bispecific engager Specifically for Neuroendocrine Prostate Cancer (NEPC). Targets DLL3 protein. Early results show higher objective response rates in DLL3-positive patients. 2 n.a. n.a. n.a.
NCT07104643 mCRPC TYK-00540 + Enzalutamide Oral inhibitor targeting CDK2/4/6. Designed to overcome resistance to earlier CDK4/6 inhibitors by disrupting multiple cell cycle pathways. 1b/2 n.a. n.a. n.a.
NCT07104617 mCRPC TY-302 + Abiraterone Combines a CDK4/6 inhibitor with Abiraterone. Aims to stop cancer cell proliferation while blocking androgen production simultaneously. 1b/2 n.a. n.a. n.a.
n.a. mCRPC / NEPC STRIKE-001 / KTX-2001 (NSD2 inhibitor) First clinical trial of NSD2 inhibitor. NSD2 drives aggressive/neuroendocrine disease and helps tumors evade the immune system. Combined with Darolutamide. 1 n.a. n.a. n.a.
n.a. mCRPC UPDATE: INKmune CaRe trial Immunotherapy priming NK cells. Effective activation seen in patients with low baseline NK activity. Some lesions disappeared completely during therapy. 1/2 n.a. n.a. n.a.
NCT07088588 mCRPC (HRR+) SYN608 / PARG inhibitor Targets the PARG enzyme in tumors with HRR deficiencies (BRCA, ATM). Lab tests show efficacy even in tumors resistant to standard PARP inhibitors. 1 n.a. n.a. n.a.
NCT07090369 mCRPC LumOnate / Triple Combo Synergistic combo: 177Lu-PSMA (radiation) + Olaparib (DNA repair block) + Pembrolizumab (immune activation). Evaluates safety of triple mechanism. 1b n.a. n.a. 66*
NCT05875168 mCRPC DS-3939a / TA-MUC1 ADC Targets tumor-associated MUC1, found in 90% of cases with lymph node spread. Uses DXd technology to deliver Topoisomerase I payload. 1/2 n.a. n.a. n.a.
NCT07189871 mCRPC Betabart (RV-01) / B7-H3 Radioligand First-in-human trial for B7-H3 targeted radioligand. Uses Lutetium-177 but clears via the liver instead of kidneys, potentially reducing renal toxicity. 1 n.a. n.a. n.a.
NCT07080242 NEPC BL-M14D1 / TROP2 ADC ADC targeting TROP2 for neuroendocrine prostate cancer. Uses stable linker to release topoisomerase I inhibitor only inside the cancerous cell. 1 n.a. n.a. n.a.
n.a. mHSPC / mCRPC Low-Dose Abiraterone (500mg) + Food Singapore hospital trial showing 500mg with meal achieves >80% enzyme occupancy. 78% achieved PSA50; 91.1% reduction seen in mCRPC cohort. 1 n.a. n.a. 78*
n.a. mCRPC (AR altered) PC-BETS Substudy C / Darolutamide Biomarker trial using ctDNA. Enriched benefit seen in patients with AR copy number >10, though overall results were modest for ARPI-to-ARPI switch. 2 n.a. n.a. n.a.
n.a. mCRPC PSMAfore / 177Lu-PSMA-617 (Pluvicto) Phase 3 trial in taxane-naive patients. Showed 59% lower risk of progression. PSA50 response rate reached 50.7% vs 14.9% for ARPI switch. 3 12.0* 24.48 50.7
n.a. mHSPC UPDATE: PSMAddition / Pluvicto Announced that Pluvicto plus standard care significantly extended rPFS in the hormone-sensitive setting. Full data expected in late 2025. 3 n.a. n.a. n.a.
n.a. mCRPC Pluvicto + TRE-515 / dCK inhibitor Combination therapy pairing Pluvicto with a first-in-class dCK inhibitor. Aims to disrupt DNA precursor supply to make cells more vulnerable to radiation. 1 n.a. n.a. n.a.
n.a. mCRPC Masitinib + Docetaxel Phase 3 trial for patients with low alkaline phosphatase (ALP ≤ 250). Previous data showed 47% reduced risk of progression in ALP ≤ 100 subgroup. 3 n.a. n.a. n.a.
NCT06190899 mCRPC CELC-G-201 / Gedatolisib + Darolutamide Targets PI3K/AKT/mTOR and AR pathways. Early results show 6-month rPFS rate of 66% with no treatment discontinuations due to side effects. 1/2 6.6* n.a. n.a.
NCT07028853 mCSPC MEVPRO-3 / Mevrometostat + Enzalutamide Phase 3 trial evaluating EZH2 inhibitor in mCSPC. Previous data in mCRPC showed rPFS of 14.3 months vs 6.2 months for enzalutamide alone. 3 14.3* n.a. 34.1*
NCT07006727 NEPC 225Ac-ETN029 / DLL3 Alpha Therapy Radiopharmaceutical using Actinium-225 to target DLL3, expressed in 77% of neuroendocrine prostate cancer (NEPC) cases. 1 n.a. n.a. n.a.
n.a. mCRPC (EBV+) WGc-043 / EBV mRNA Vaccine Targets tumors linked to Epstein-Barr virus. Explores the connection between EBV and advanced disease stages in subsets of PCa patients. 1 n.a. n.a. n.a.
n.a. mCRPC Cu-61 NuriPro / PSMA Imaging Next-gen PET imaging agent. Detected more lesions in 50% of patients compared to F-18 tracers. Therapeutic Cu-67 version planned for 2026. 1 n.a. n.a. n.a.
n.a. mCRPC 225Ac-LNC1011 / Alpha Emitter Targeted alpha therapy showing 50% ORR (RECIST) and 75% ORR (PET-based). One patient achieved a PSA drop from 7.8 to 0.18 ng/mL. 1 n.a. n.a. 100*
n.a. mCRPC ART-101 / PSMA small molecule Theranostic small molecule with higher tumor retention and lower salivary uptake than approved agents. Compatible with Ac-225 and Lu-177. 1 n.a. n.a. n.a.
NCT06907043 mCRPC EIK1004 (IMP1707) / PARP1 inhibitor Selective PARP1 inhibitor designed to cross the blood-brain barrier. Aims to treat CNS metastases while sparing PARP2 to reduce side effects. 1/2 n.a. n.a. n.a.
NCT06943521 mCRPC / NEPC MT-4561 / BRD4 Degrader Destroys BRD4 protein via ubiquitin-proteasomal degradation. Targets the BRD4-KDM5C-PTEN axis which drives CRPC evolution and invasion. 1/2 n.a. n.a. n.a.
NCT07024277 NEPC ZG006 / DLL3 Trispecific Engager Trispecific T-cell engager targeting two DLL3 sites. Preclinical studies showed complete disappearance of tumors in some models. 2 n.a. n.a. n.a.
NCT06925737 mCRPC IDeate-Prostate01 / Ifinatamab Deruxtecan Phase 3 trial comparing B7-H3 ADC vs Docetaxel. Early data showed 25% response rate in heavily pretreated mCRPC patients. 3 n.a. n.a. n.a.
NCT07007910 mCRPC HSK46575 / CYP11A1 inhibitor Small molecule targeting an earlier step in hormone production than abiraterone. Designed to stay longer in the body with once-daily dosing. 1 n.a. n.a. n.a.
NCT07002320 mCRPC ASpiRE / SX-682 + Apalutamide Targets CXCR1/2 to dismantle the 'immunosuppressive cloak' (MDSCs) that shields PCa from the immune system. Combined with AR inhibitors. 1/2 n.a. n.a. n.a.
NCT06999187 mCRPC DR-0202 / CLEC7A Bispecific Antibody Leverages myeloid cells to engulf tumor cells. Priming mechanism teaches T-cells to recognize unique tumor markers for long-lasting immunity. 1a/1b n.a. n.a. n.a.
NCT06895811 mCRPC BRL-302 / Switchable CAR-T UCAR technology with a 'light switch' control. Allows doctors to turn off T-cell activity within hours if side effects (CRS) become too strong. 1 n.a. n.a. n.a.
n.a. mCRPC PMR-116 / MYC inhibitor Disrupts the rRNA synthesis machinery that the MYC oncogene depends on. Preclinical data: 85% reduction in MYC-driven prostate cancer lesions. 1 n.a. n.a. n.a.
n.a. mCRPC OncoACP3 / ACP3 Targeted Radioligand Targets Acid Phosphatase 3, highly specific to PCa. Compatible with Actinium-225 for high localized tumor kill with reduced side effects. 1 n.a. n.a. n.a.
NCT06982222 mCRPC (Bone Metastases) Sn-117m-DTPA / Tin Radiopharmaceutical Theranostic agent for painful bone metastases. Emits low-energy electrons to treat the bone while sparing marrow toxicity. 30% achieved complete pain resolution. 1/2 n.a. n.a. n.a.
NCT05932862 mCRPC (BRCA+) XL309 / USP1 inhibitor Targets DNA repair enzyme USP1. Designed to overcome or synergize with standard PARP inhibitor therapy in BRCA-mutated tumors. 1 n.a. n.a. n.a.
NCT06801236 mCRPC UPDATE: ACE-232 / CYP11A1 inhibitor Novel oral inhibitor showing potential superiority to earlier CYP11A1 drugs. Aims to suppress androgen production even in treatment-resistant cases. 1 n.a. n.a. n.a.
n.a. mCSPC (HRR+) AMPLITUDE Update / Niraparib + Abiraterone Combination therapy reduced progression risk by 37% in all HRR mutated and 48% specifically in BRCA1/2 mutated hormone-sensitive patients. 3 29.5* n.a. n.a.
n.a. Localized (Intermediate/High Risk) CAN-2409 / Biological Immunotherapy Viral therapy delivering HSV-tk gene to tumors. 30% reduction in recurrence risk when combined with radiation and valacyclovir. 3 n.a. n.a. 67.1
NCT05413421 mCRPC ORIC-944 / PRC2 inhibitor Allosteric inhibitor combined with ARPIs. Deep responses seen: 59% PSA50 and 24% PSA90 response rates in patients who failed prior AR therapies. 1b n.a. n.a. 59
NCT06991556 mHSPC JSB462 (Luxdegalutamide) + Abiraterone PROTAC degrader targeting wild-type and mutated AR. Aims to physically eliminate the receptor to prevent resistance found in 24% of mCRPC cases. 2 n.a. n.a. 43*
NCT04939610 mCRPC LuMIERE / 177Lu-FAP-2286 Radioligand targeting CAFs in the tumor microenvironment. Effectively treats bone metastases (3.0 Gy/GBq) with minimal kidney or marrow exposure. 1/2 n.a. n.a. n.a.
n.a. mCRPC (HRR+) TALAPRO-2 / Talazoparib + Enzalutamide Subgroup analysis showed most pronounced benefit in BRCA2 (rPFS 30.7m vs 12.3m). Significant response also seen in CDK12 and ATM subgroups. 3 30.7* 45.1* 69.4
n.a. mCRPC 177Lu-PSMA-I&T (Swiss registry) Prospective registry of 333 patients. Confirmed safety and efficacy comparable to Pluvicto. 17% achieved PSA90 response. 2 6.5* 13 41
NCT02446405 mHSPC ENZAMET (8-Year Follow-up) / Enzalutamide Landmark trial showing enzalutamide extended median OS by 25 months vs older NSAAs. Median OS was 95 months in the treatment group. 3 n.a. 95 n.a.
NCT04898634 mCRPC JNJ-78278343 (Pasritamig) / KLK2 T-cell engager Targets KLK2 (specific to PCa tissue). PSA50 response rate of 42.4% in heavily pretreated patients. Durable responses up to 11.2 months. 1 6.77 n.a. 42.4
NCT06383052 mCRPC 177Lu-NYM032 / PSMA Radioligand Novel Chinese radionuclide conjugate engineered to maximize radiation to tumor while sparing healthy tissue. 67% PSA50 response rate. 1 n.a. n.a. 67
NCT05682443 mCRPC PRESERVE-006 / 177Lu + Gotistobart (BNT316) Pluvicto combined with innovative anti-CTLA-4. Depleting Tregs in the tumor microenvironment amplified Pluvicto response (66.7% vs 16.7%). 1/2 n.a. n.a. 66.7*
n.a. mCRPC VIOLET / 161Tb-PSMA-I&T Uses Terbium-161 (beta + Auger emissions). Auger electrons enhanced destruction of micrometastases. 70% PSA50 response achieved. 1/2 11.1 n.a. 70
NCT06139575 mCRPC JH020002-01C / 177Lu-JH020002 Heavily pretreated cohort (including Ra-223 and PARPi). 63.6% PSA50 response rate at higher doses, with one partial radiographic response. 1/2 n.a. n.a. 63.6
n.a. mCRPC MHB088C / B7-H3 ADC Uses 'SuperTopoi' payload, 5-10 times more potent than standard ADC toxins. 6-month rPFS was 87% in heavily pretreated mCRPC. 1/2 n.a. n.a. n.a.
NCT03460977 mCRPC UPDATE: Mevrometostat (EZH2 inhibitor) Phase 2 expansion for abiraterone-experienced patients. Median rPFS significantly improved to 14.3 months vs 6.2 for enzalutamide alone. 2 14.3 n.a. 34.1
NCT03317392 mCRPC COMRADE / Olaparib + Radium-223 Combination for bone metastases. Improved rPFS regardless of HRR status. Significantly delayed time to next treatment (12.0m vs 7.7m). 2 8.6* n.a. n.a.
n.a. mCRPC TALAPRO-2 / Talazoparib + Enzalutamide Final OS analysis for all-comers. Median OS reached 45.8 months vs 37.0 months for enzalutamide alone. Benefit was strongest in HRR-mutated patients (nearly 50% death risk reduction). 3 33.1 45.8* n.a.
n.a. mCRPC PT-112 / Pyrophosphate Platinum Novel platinum agent with osteotropism for bone metastases. Induces immunogenic cell death. 17% of patients in Phase 1 achieved rPFS ≥ 6 months. 3 6* n.a. n.a.
n.a. mCRPC KEYNOTE-641 / Pembrolizumab + Enzalutamide Trial stopped for futility. Addition of pembrolizumab did not improve OS (24.7m vs 27.3m) or rPFS and increased toxicity in chemo-naive patients. 3 10.4 24.7 n.a.
n.a. mCRPC UPDATE: JANX007 / PSMA-TRACTr Tumor-activated T-cell engager. Phase 1a data showed 7.9 months median rPFS at higher doses with 78% 6-month rPFS rate. Expanding to taxane-naive and ARPi resistant cohorts. 1b 7.9* n.a. 100
n.a. mCRPC NTS071 / p53 Y220C Mutation Target AI-designed small molecule targeting the p53 Y220C mutation. Stabilizes mutant p53 to restore tumor suppressor function. Tumor-agnostic approach including PCa. 1 n.a. n.a. n.a.
n.a. mCRPC CAPItello-280 / Capivasertib + Docetaxel Trial discontinued. Regimen unlikely to meet primary endpoints of rPFS and OS in the overall population of patients progressed on ADT. 3 n.a. n.a. n.a.
NCT05415098 mCRPC APG-5918 / EED inhibitor Inhibitor of EED (PRC2 component). Synergistic with enzalutamide in preclinical models. Induces G0/G1 cell cycle arrest even in AR-independent tumors. 1 n.a. n.a. n.a.
NCT06224387 mCRPC CTS2190 / PRMT1 inhibitor Orally available inhibitor of PRMT1. Causes degradation of AR, including resistant AR-V7 variants. Outperformed standard treatments in preclinical CRPC models. 1 n.a. n.a. n.a.
NCT06666270 mCRPC (HRR+) SYN818 / DNA Polymerase Theta (POLQ) inhibitor Exploits vulnerabilities in tumors with BRCA1/2 or ATM mutations. Intended to be combined with PARP inhibitors to intensify DNA damage in HRR-deficient cells. 1 n.a. n.a. n.a.
NCT05873686 mCRPC NXP900 / SFK inhibitor Locks SRC and YES1 kinases in an inactive form. Preclinical data suggests it can reverse acquired resistance in mCRPC models when combined with enzalutamide. 1 n.a. n.a. n.a.
NCT06318273 mCRPC ABBV-969 / Bispecific ADC (STEAP1 + PSMA) Dual-targeting ADC engaging both STEAP1 and PSMA. Aimed at improving tumor cell coverage in heterogeneous tumors using a topoisomerase-1 inhibitor payload. 1 n.a. n.a. n.a.
NCT05800665 mCRPC GDC-2992 / AR Degrader + Antagonist Dual-action molecule: degrades AR protein via cereblon (CRBN) and acts as a competitive antagonist. Effective against resistant AR mutants in preclinical models. 1 n.a. n.a. n.a.
n.a. mCRPC (HRR+) IMP1734 (EIK1003) / PARP1 inhibitor Next-gen PARP1-selective inhibitor. Designed to spare PARP2 to reduce common side effects like anemia and low white blood cell counts seen with older PARP inhibitors. 1/2 n.a. n.a. n.a.
n.a. mCRPC GSK5764227 (HS-20093) / B7-H3 ADC Antibody-drug conjugate targeting B7-H3, prevalent in aggressive PCa. Tested alone and with cisplatin or pembrolizumab. Already showed promise in Asian studies. 1 n.a. n.a. n.a.
n.a. nmHSPC Grape Seed Extract (GSE) / Phytochemical Phase 2 trial for biochemical recurrence. GSE significantly slowed PSA doubling time (PSADT) from 5.7 to 6.8 months. 78% of men saw some benefit. 2 n.a. n.a. 37*
n.a. mCRPC / NEPC BA1106 / anti-CD25 antibody Depletes regulatory T cells (Tregs) to shift the balance toward anti-tumor immunity. Does not block IL-2 signaling. Shown durable control in neuroendocrine models. 1 n.a. n.a. n.a.
n.a. mCRPC Q702 / Axl, Mer, CSF1R triple inhibitor Blocks three proteins that drive resistance and shield tumors from the immune system. Demonstrated target engagement and stable disease in heavily pretreated patients. 1 n.a. n.a. n.a.
NCT03972657 mCRPC Nezastomig (REGN5678) + Cemiplimab Combination of bispecific antibody and PD-1 booster. 25% achieved PSA50 at higher doses. Survival was 17.3m vs 10.3m for lower doses, but safety is a concern (14% severe reactions). 1/2 5.0* 17.3* 25
n.a. nmHSPC TGW101 / TAG-72 ADC ADC targeting TAG-72 using 'Click-to-Release' technology. Primarily present in early/localized PCa (88%) but expression drops in late metastases. 1 n.a. n.a. n.a.
NCT06657222 mCRPC Tubulis / 5T4-targeted ADC Targets 5T4 oncofoetal glycoprotein. High expression in mCRPC. Uses a stable cleavable linker and Exatecan payload to improve targeting precision. 1 n.a. n.a. n.a.
NCT06926075 mCRPC ADVICE / Kesonotide Dual anti-inflammatory and chemo drug targeting Vimentin in both tumor cells and the supporting microenvironment (TME). Blocks EMT and invasiveness. 1b/2a n.a. n.a. n.a.
NCT06573294 mCRPC GEN1057 / DuoBody-FAPαxDR4 Bispecific antibody that triggers apoptosis (DR4) only when FAP-alpha is nearby. High localized precision avoids liver damage seen with earlier DR4 drugs. 1 n.a. n.a. n.a.
NCT06863272 mCRPC MK-2400 (Ifinatamab Deruxtecan) / TROP2 ADC ADC targeting TROP2. Interim data in NSCLC showed 52.4% ORR. Evaluating if similar strong responses occur in TROP2-expressing prostate cancers. 1 n.a. n.a. n.a.
NCT06922318 mCRPC COSMYC / ZEN-3694 + BAT Combined suppression of MYC. Pairs BET inhibitor (ZEN-3694) with Bipolar Androgen Therapy (BAT) to sensitize tumors to subsequent enzalutamide treatment. 2 n.a. n.a. n.a.
NCT06909825 mCRPC FPI-2265 (225Ac-PSMA) + Olaparib Combines Targeted Alpha Therapy with PARP inhibitor. Enrolment does not require HRR mutation. Aims to enhance DNA damage via Alpha-radiation and repair-blockade. 2 n.a. n.a. n.a.
NCT06889493 mCRPC / NEPC SVV-001 + Checkpoint inhibitors Seneca Valley Virus (Oncolytic virus) combined with Nivolumab/Ipilimumab. Virus selectively kills tumor cells and releases antigens to turn 'cold' neuroendocrine tumors 'hot'. 1 n.a. n.a. n.a.
n.a. mCRPC FC705 / PSMA Radioligand (Korea) Achieved 60% ORR in Phase 2 for bone/soft tissue. PSA50 response rate of 73.3% significantly outperformed VISION benchmarks (46%). 2 n.a. n.a. 73.3
n.a. n.a. PGV001 / Personalized Cancer Vaccine Multi-peptide neoantigen vaccine. At 5-year follow-up, 3 of 13 patients remained tumor-free. Stimulates immune response to prevent recurrence after surgery/chemo. 1 n.a. 60* n.a.
NCT06910657 mCRPC IDOV-Immune / Oncolytic Virus Based on Vaccinia virus. Engineered to selectively infect and rupture cancer cells (oncolysis), acting as a personalized vaccine inside the body. 1 n.a. n.a. n.a.
NCT06260774 mCRPC TTX-MC138 / RNA Therapeutic Inhibits miR-10b, a master regulator of metastasis. Delivered via nanoparticle platform. Achieved persistent regression of metastases in preclinical models. 1 n.a. n.a. n.a.
n.a. mCRPC UPDATE: ENV105 / Carutoximab Safety lead-in completed for combo with apalutamide. Aims to reverse resistance to ARSIs by targeting CD105 in the tumor microenvironment. 2 13* n.a. n.a.
n.a. mCRPC FOR46 (FG-3246) / CD46 ADC Targets CD46 protein on PCa cells. PSA50 response rate of 36% and ORR 20%. Median rPFS of 8.7 months in patients who exhausted prior ARPIs. 1 8.7 n.a. 36
n.a. mCRPC (Bone metastases) SKB107 / TBM-001 (RDC) Chinese Radionuclide-Drug Conjugate (RDC). Targets and destroys bone lesions directly. Designed to manage pain and fractures in 80% of metastatic patients. 1 n.a. n.a. n.a.
n.a. mCRPC Pocenbrodib / p300/CBP inhibitor First AI-designed drug to enter mCRPC trials. Targets p300/CBP epigenetic regulators. Developed from initiation to human dosing in under 30 months. 1/2 n.a. n.a. n.a.
n.a. mHSPC LIBERTAS / Apalutamide + Intermittent ADT Investigates de-escalation by using apalutamide alone if PSA < 0.2 after 6 months. High initial success: 71% achieved undetectable PSA. 3 n.a. n.a. 71*
NCT06879041 mCRPC AZD2284 + AZD2287 + AZD2275 Actinium-225 therapy phase. Explores a strategy utilizing biomarkers PSMA and STEAP2 simultaneously to improve biodistribution and therapeutic effect. 1 n.a. n.a. n.a.
NCT05413850 mCRPC 177Lu rhPSMA-10.1 / rhPSMA Radioligand Next-gen radiohybrid PSMA. Demonstrated 100% PSA reduction in pilot cases. Tumor-to-healthy tissue ratio is superior to traditional PSMA ligands. 1/2 24* n.a. 100*
n.a. mCRPC UPDATE: FutureChem FC705 / PSMA radioligand Phase 3 trial in Korea. Uses an albumin-binding ligand to extend blood circulation. 60% achieved PSA50 in Phase 2 despite heavy prior treatment. 3 n.a. n.a. 60*
NCT06541639 mCRPC EVM16 CX01 / Personalized mRNA Vaccine AI-based neoantigen prediction algorithm EVER-NEO-1. Encodes patient-specific mutations. Combined with Tislelizumab (anti-PD-1) to boost effectiveness. 1 n.a. n.a. n.a.
NCT06782555 mCRPC IMGS-101 (Evofosfamide) + Checkpoint inhibitors Hypoxia-modifying agent. Targets low oxygen tumor zones which usually restrict T-cell infiltration. Aims to restore checkpoint inhibitor efficacy in mCRPC. 1/2 n.a. n.a. n.a.
n.a. mCRPC UPDATE: SECuRE / 67Cu-SAR-bisPSMA Copper-67 based radiopharmaceutical. Data shows 92% response rate (PSA >35% reduction) in pre-chemotherapy participants. 45% achieved PSA50 response. 2 n.a. n.a. 45
NCT06855277 mCRPC AAA817 / 225Ac-PSMA-617 + ARPI Phase 3 trial evaluating Targeted Alpha Therapy (Ac-225) in combination with ARPI for chemo-naive patients. Targets PSMA-positive tumor cells with high localized energy. 3 9.1* 12.5* 66*
NCT06842498 mCRPC FG-3246 (FOR46) / CD46 ADC Antibody-drug conjugate targeting CD46. Phase 1b results with enzalutamide showed a median rPFS of 10.2 months in biomarker-unselected patients. 2 10.2 n.a. n.a.
NCT06229366 mHSPC / mCRPC ACCEL / Actinium-225-PSMA-62 Investigates Ac-225 alpha therapy in oligometastatic hormone-sensitive (OmHSPC) and mCRPC. PSMA-62 ligand is engineered for better cellular internalization. 1/2 n.a. n.a. n.a.
NCT04876651 mCRPC ProstACT Global / TLX591 Uses the rosopatamab antibody to carry Lutetium-177. Binds to PSMA with higher affinity than peptides, allowing for lower radiation doses and fewer side effects. 3 n.a. n.a. n.a.
NCT06840535 mCRPC OncoACP3 / ACP3 Targeted Radiotracer Targets Acid Phosphatase 3 (ACP3), which is more specific to PCa than PSMA. Aims for clearer imaging and more potent localized radiotherapy when paired with Ac-225. 1 n.a. n.a. n.a.
NCT05534646 mCRPC ENV105 (Carutoximab) + Apalutamide Targets CD105 (endoglin) to disrupt the BMP signaling pathway. Designed to restore sensitivity to AR inhibitors in treatment-resistant tumors. 2 n.a. n.a. n.a.
NCT04868604 mCRPC UPDATE: SECuRE / 67Cu-SAR-bisPSMA Copper-67 radioligand. Fast Track granted after one patient achieved complete response (undetectable PSA for 13 months) following two 8 GBq doses. 1/2 n.a. n.a. 45
n.a. mCRPC (Visceral/Liver) COSMIC-021 / Cabozantinib + Atezolizumab Combination for patients with visceral metastases. In the liver subgroup, median survival reached 14.7 months vs 5.0 months for cabozantinib alone. 1 n.a. 14.7* n.a.
n.a. mHSPC STAMPEDE / Transdermal Estradiol Comparison of estrogen patches vs LHRHa injections. Shows identical PSA response rates with better bone health and lower cardiovascular risk. 2 n.a. n.a. n.a.
n.a. mCRPC (HRR+) Final OS TALAPRO-2 / Talazoparib + Enzalutamide Final results for HRR-deficient patients. Median OS of 45.1 months. BRCA1/2 group median OS not reached vs 28.5m in placebo. 3 30.7* 45.1* n.a.
n.a. mCRPC CBP-1018 / Bi-ligand-drug conjugate Dual-targeting drug conjugate. Showed 88% disease control rate and 66% 7-month rPFS rate in heavily pretreated patients who failed taxanes and ARPIs. 1/2 n.a. n.a. n.a.
n.a. Localized (Slow progress) Gut-Prostate Axis / Phytochemicals + Probiotics Double-blind trial using supplement with ginger, green tea, etc. Adding probiotics reversed PSA growth from 21.7% rise to 20% decrease. n.a. n.a. n.a. n.a.
n.a. mCRPC UPDATE: Mevrometostat (EZH2 inhibitor) Phase 1 update showing 49% reduction in death risk when combined with hormone therapy in patients previously treated with taxanes. 1 n.a. n.a. n.a.
n.a. mCRPC MaaT Pharma / Microbiome Therapy Restoring microbial diversity to enhance immunotherapy. transplantation of microbiota alongside anti-PD1 shown to improve response rates. n.a. n.a. n.a. n.a.
n.a. mCRPC / NEPC BR111 / ROR1-targeted ADC ADC targeting ROR1, expressed in castration-resistant small cell and neuroendocrine prostate cancers. Dual-epitope mechanism to reduce escape mutations. n.a. n.a. n.a. n.a.
NCT07244393. mCRPC 177Lu-DGUL + Keytruda First Korean trial combining radioligand and immune checkpoint inhibitor. PSMA-targeting radiation primes the tumor for anti-PD1 therapy. 1 n.a. n.a. n.a.
n.a. mCRPC (PCPro+) Opaganib + Darolutamide Targets sphingosine kinase-2 (SPHK2) to overcome resistance to AR inhibitors. Uses a specific lipid biomarker test (PCPro) for patient selection. 2 n.a. n.a. n.a.
NCT06800313 mCRPC HLD-0915 / RIPTAC Regulated Induced Proximity Targeting Chimera. Induces proximity between AR and transcriptional regulators to cause selective cancer cell death. 1 n.a. n.a. 59
NCT06801236 mCRPC ACE-232 / CYP11A1 inhibitor Selective oral inhibitor designed to overcome resistance caused by AR-LBD mutations or amplification. Suppresses androgen production more potently than abiraterone. 1 n.a. n.a. n.a.
NCT06265727 mCRPC CRB-701 (SYS6002) / Nectin-4 ADC ADC targeting Nectin-4, overexpressed in many PCa cases. Preliminary data across solid tumors showed ORR of 40% at doses ≥ 2.7 mg/kg. 1/2 n.a. n.a. n.a.
NCT06465069 mCRPC LY4052031 & LY4101174 / Nectin-4 ADCs Novel ADCs combining human monoclonal antibody with topoisomerase I inhibitor payload. Designed to target both high and low Nectin-4 expressing tumors. 1a/1b n.a. n.a. n.a.
NCT06056791 mCRPC CaRe Trial / INKmune Immunotherapy that "awakens" the patient's dormant NK cells. Expanded to include U.S. veterans. Administered via outpatient infusion. 1/2 n.a. n.a. n.a.
NCT06785636 mCRPC Pocenbrodib / p300/CBP inhibitor Inhibitor of epigenetic regulators p300/CBP discovered via AI. Tested as monotherapy and in combination with ARPI, Olaparib, or Pluvicto. 1 n.a. n.a. n.a.
NCT06782555 mCRPC Evofosfamide + Checkpoint Inhibitors Drug activated by tumor hypoxia. Aims to destroy the oxygen-deprived zones that shield the tumor from the immune system. 1/2 n.a. n.a. n.a.
NCT06780670 mCRPC AAA817 / 225Ac-PSMA-617 Registrational study for Actinium-225 alpha therapy in patients previously treated with Lutetium-177 (Pluvicto) and taxanes. 2/3 n.a. n.a. 66*
NCT06781983 mCRPC IPH4502 / Nectin-4 ADC ADC that links an anti-Nectin-4 antibody to the Exatecan payload. Targeted at tumors with variable Nectin-4 expression, including prostate cancer. 1 n.a. n.a. n.a.
NCT05369000 mCRPC LAVA-1207 / T-cell engager Development discontinued for failure to meet internal efficacy benchmarks, despite positive PSA reduction signals in some patients. 1 n.a. n.a. n.a.
NCT06778863 mCRPC (p53 mutant) CLSP-1025 / p53 R175H targeted engager T-cell engager ultra-preciso che bersaglia specificamente la forma mutata della proteina p53, presente in molti tumori solidi aggressivi. 1 n.a. n.a. n.a.
n.a. mCRPC VIR-5500 / PSMA T-cell engager Bispecific antibody with masking technology to activate only on the tumor. 58% of patients achieved PSA50 response. 1 n.a. n.a. 58
n.a. mCRPC ORIC-944 / PRC2 inhibitor Allosteric inhibitor of the PRC2 complex combined with ARPI. Durable PSA90 responses (up to 38 weeks) observed in phase 1b. 1b n.a. n.a. 50*
n.a. Localized (High risk) CAN-2409 / Oncolytic Immunotherapy Adenovirus injected into the tumor that activates the drug Valtrex (valacyclovir). 30% reduction in the risk of recurrence in high-risk localized prostate cancer. 3 n.a. n.a. n.a.
NCT06764485 mCRPC BMS-986365 / AR Degrader + Antagonist Dual mechanism: degrades the androgen receptor and blocks it. In phase 1, 70% of patients had a 30% PSA decline. 3 6.3* n.a. n.a.
n.a. mCRPC PNKP inhibitor / DNA repair target Targets the enzyme PNKP to sensitize cancer cells to radiotherapy or chemotherapy by preventing DNA repair. 1 n.a. n.a. n.a.
NCT06710379 mCRPC ADRX-0405 / STEAP1 ADC ADC with a drug-to-antibody ratio (DAR) of 8. It targets STEAP1, which is highly expressed in the prostate and almost absent in healthy tissues. 1 n.a. n.a. n.a.
NCT05719558 mCRPC ASP1002 / Claudin 4 Bispecific Binds Claudin 4 on the tumor and CD137 on T cells. Activates the immune system against tumors expressing Claudin 4 (frequent in prostate cancer). 1 n.a. n.a. n.a.
NCT06734130 mCSPC Adaptive ADT + Docetaxel A model of intermittent hormonal therapy guided by individualized algorithms based on PSA response to reduce long-term toxicity. 2 n.a. n.a. n.a.
n.a. nmCRPC WOMBAT / BAT + Darolutamide Australian study on Bipolar Androgen Therapy in M0 patients with rising PSA during darolutamide. 2 n.a. n.a. n.a.
NCT06705686 mCRPC PHAROS / (R)-9bMS (ACK1 inhibitor) ACK1 protein inhibitor. Could reduce AR-V7 levels, making cancer sensitive again to standard hormone therapies. 1 n.a. n.a. n.a.
n.a. mCRPC KPG-121 / Cereblon modulator Cereblon modulator with anti-angiogenic effect. Early efficacy: 37.5% partial response and 75% disease control rate. 1 n.a. n.a. 37.5
NCT05652686 NEPC SKYBRIDGE / PT217 (DLL3 x CD47) First-in-class bispecific antibody targeting DLL3 and CD47. Specifically designed for neuroendocrine prostate cancer (NEPC) and small cell lung cancer. 1/2 n.a. n.a. n.a.
n.a. mCRPC (Low PSMA) 67Cu-SAR-bisFAP / 67Cu-SAR-Bombesin Radiopharmaceuticals for patients with low PSMA expression. Targets Gastrin-Releasing Peptide receptor (GRPr) or Fibroblast Activation Protein (FAP) in the microenvironment. 1 n.a. n.a. n.a.
n.a. n.a. Ketogenic Diet / Beta-hydroxybutyrate (BHB) Investigates how T-cells favor BHB as energy. A ketogenic diet or BHB supplements may supercharge CAR-T therapy by improving immune cell metabolism. 1 n.a. n.a. n.a.
NCT06095089 mCRPC JNJ-87189401 + JNJ-78278343 Dual bispecific antibody approach targeting PSMA and KLK2. JNJ-87189401 provides CD28 costimulation while JNJ-78278343 activates CD3 T-cells. 1 n.a. n.a. n.a.
n.a. mCRPC UPDATE: Xaluritamig (AMG 509) / STEAP1 T-cell engager Phase 1/2 update: 36-60% PSA50 response rate. Median overall survival reached 17.7 months, comparable to Pluvicto, but targeting STEAP1 instead of PSMA. 1/2 8.3* 17.7 60*
NCT04969835 mCRPC (FAP+) AVA6000 / FAP-activated Doxorubicin Peptide Drug Conjugate (PDC) that releases chemotherapy only when cleaved by FAP enzymes in the tumor. Dramatically reduces systemic toxicity of doxorubicin. 1 n.a. n.a. n.a.
NCT06582017 mCRPC QXL138AM / CD138-targeted Mic Masked immuno-cytokine targeting CD138. Preclinical models showed 69% tumor growth inhibition in PCa. Mask is removed only in the tumor microenvironment. 1 n.a. n.a. n.a.
NCT06609005 mCRPC INV-9956 / CYP11A1 inhibitor Inhibits hormone biosynthesis at the first step. Potent against AR L702H mutations. Superior tumor inhibition vs competitors in preclinical VCaP models. 1 n.a. n.a. n.a.
n.a. mCRPC / nmHSPC Copper-61 NODAGA-PSMA / Precision Imaging Phase 1 trial for a new isotope with a 3.3-hour half-life. Aims to detect PSMA-positive lesions with better accessibility and geographic distribution than 68Ga. 1 n.a. n.a. n.a.
n.a. mCRPC VVD-130850 / STAT3 inhibitor Oral allosteric inhibitor of STAT3. Blocks hyperactivation of STAT3 which drives metastasis and immune evasion in advanced prostate cancer. 1 n.a. n.a. n.a.
NCT04221542 mCRPC Xaluritamig (AMG 509) Phase 3 / STEAP1 T-cell engager Randomized Phase 3 comparing xaluritamig vs cabazitaxel or AR switch. For patients previously treated with taxane chemotherapy. 3 n.a. n.a. n.a.
n.a. nmHSPC (Active Surveillance) High Omega-3 Diet + Fish Oil / Ki-67 marker Trial in 100 men on active surveillance. Intervention group saw 15% reduction in Ki-67 (proliferation marker) compared to 24% increase in the control group. n.a. n.a. n.a. n.a.
n.a. mCRPC STARt-001 / Invikafusp Alfa (STAR0602) Selectively activates specific T-cell subsets. 50% disease control rate in anti-PD-1 resistant patients. TMB-H subgroup showed 25% ORR. 1/2 n.a. n.a. n.a.
n.a. mCRPC AO-252 / TACC3 inhibitor Targets TACC3 protein involved in cancer cell proliferation. Preclinical studies support efficacy in prostate cancer by restraining primary cilium formation. 1 n.a. n.a. n.a.
NCT01436968 Localized (High risk) PrTK03 / CAN-2409 + Radiotherapy Viral immunotherapy using HSV-tk. Phase 3 met primary endpoint with 14.5% improvement in Disease-Free Survival (DFS) in intermediate-to-high risk patients. 3 n.a. n.a. n.a.
n.a. mCRPC RaLu Trial / Ra-223 followed by Lu-177 Retrospective study showing Radium then Lutetium sequence is safe and feasible. Outcomes were similar regardless of time interval or prior taxane use. Retrospective n.a. 13.2* n.a.
n.a. mCRPC LNCB74 / B7-H4 ADC ADC targeting B7-H4, which suppresses the immune system in aggressive PCa. Preclinical data shows significant advantages over existing B7-H4 agents. 1 n.a. n.a. n.a.
n.a. mCRPC OP-3136 / KAT6 inhibitor Potent and selective small molecule inhibitor of KAT6 epigenetic regulators. Aims to disrupt oncogenic transcriptional programs. 1 n.a. n.a. n.a.
n.a. mCRPC Talazoparib + Enzalutamide (Comparison) Matching-adjusted indirect comparison showing TALA+ENZA has superior rPFS compared to Olaparib/Abiraterone or Niraparib/Abiraterone. n.a. 30.7* n.a. 69.4*
n.a. mCRPC BNT324 (DB-1311) / B7-H3 ADC ADC targeting B7-H3. Phase 1 interim data showed 28% objective response rate and 7.2 months median rPFS in mCRPC. 1/2 7.2 n.a. n.a.
n.a. mHSPC STAMPEDE / Metformin Metformin reduced metabolic side effects (weight gain) and lowered death risk by 10% in non-diabetic mHSPC patients. 3 n.a. n.a. n.a.
n.a. mCRPC JANX007 / PSMA-TRACTr Phase 1a results Tumor-activated T-cell engager. 100% of patients achieved PSA50 and 63% achieved PSA90. 50% ORR in RECIST evaluable patients. 1a n.a. n.a. 100
n.a. mHSPC (PTEN-deficient) CAPItello-281 / Truqap (Capivasertib) AKT inhibitor for PTEN-deficient mHSPC (25% of cases). Significantly improved rPFS when added to abiraterone and ADT. 3 n.a. n.a. n.a.
n.a. mHSPC ARANOTE / Darolutamide + ADT Randomized trial showing 46% reduction in radiographic progression or death compared to placebo + ADT. FDA accepted sNDA for this chemotherapy-free regimen. 3 n.a. n.a. 62.6*
NCT06551324 mCRPC MEVPRO-1 / Mevrometostat (EZH2 inhibitor) Phase 3 trial evaluating EZH2 inhibitor in men previously treated with abiraterone. EZH2 is a major driver of neuroendocrine differentiation. 3 n.a. n.a. n.a.
NCT04497844 mCSPC (HRR+) AMPLITUDE / Niraparib + Abiraterone Evaluates combined PARP/AR inhibition in frontline hormone-sensitive setting for HRR-mutated patients. Primary endpoint is rPFS. 3 n.a. n.a. n.a.
NCT01436968 Localized (Intermediate-High risk) CAN-2409 / Oncolytic virus immunotherapy Uses inactivated herpes virus to deliver toxic genes to cancer cells. Aiming for improved disease-free survival in localized cases. 3 n.a. n.a. n.a.
n.a. mCRPC (Oligoprogressive) MEDCARE / Progression-directed therapy (PDT) Radiotherapy targeted at new/progressing lesions while continuing current systemic therapy. Delayed next systemic treatment by median 17 months. 2 n.a. n.a. n.a.
NCT05204927 mCRPC ECLIPSE / 177Lu-PSMA-I&T Targeted radiation therapy vs NHA switching. Significantly prolonged rPFS in PSMA-positive patients who failed one prior ARPI. 3 n.a. n.a. n.a.
n.a. NEPC / Small Cell Pembrolizumab + Chemotherapy (UCLA Study) Combines anti-PD1 with standard chemotherapy for aggressive small cell variants. Median survival reached 27 months (vs 9m historical). 1 n.a. 27 n.a.
n.a. Localized / nmHSPC White Button Mushroom (Agaricus bisporus) / MDSC target Integrative oncology study. Supplements reduced myeloid-derived suppressor cells (MDSCs) and increased anti-tumor T cells/NK cells in humans. 2 n.a. n.a. n.a.
n.a. mCRPC WB-EMS / Whole-body electromyostimulation Muscle stimulation training program. Serum collected from patients post-exercise significantly inhibited growth of PCa cells in vitro. n.a. n.a. n.a. n.a.
NCT02655822 mCRPC Ciforadenant / Adenosine 2A Receptor block Targets adenosine-induced immunosuppression. 21% partial response (PSA >30%) when combined with atezolizumab. 1 n.a. n.a. n.a.
n.a. mCRPC ProstACT GLOBAL / 177Lu-DOTA-rosopatamab (TLX591) Randomized Phase 3 for TLX591 radiopharmaceutical. Focuses on survival, QoL, and biodistribution in progressive mCRPC patients. 3 n.a. n.a. n.a.
NCT03724747 mCRPC Thorium-227 (BAY2315497) / Targeted Alpha Therapy PSMA-TTC (Thorium conjugate). Effective in models resistant to standard enzalutamide. Synergistic with darolutamide in bone metastasis models. 1 n.a. n.a. n.a.
n.a. mCRPC Benfo-Oxythiamine (B-OT) / Radiosensitizer Inhibits transketolase enzymes to sensitize tumor cells to 177Lu-PSMA. A case report showed substantial PSA decline and metastasis regression. 1 n.a. n.a. n.a.
n.a. mCRPC Blue Earth / 177Lu rhPSMA-10.1 Dosimetry findings revealed high tumor-to-organ radiation ratios. Phase 2 trial will test front-loaded radioactivity to extend treatment duration. 1/2 n.a. n.a. n.a.
n.a. mCRPC Masofaniten (EPI-7386) + Enzalutamide Phase 2 trial halted. Interim review showed no added benefit of masofaniten over enzalutamide alone in PSA90 response rates. 2 n.a. n.a. n.a.
n.a. mCRPC Camcevi / Leuprolide Mesylate (3-month) New depot formulation for ADT. 97.9% of patients in Phase 3 trial maintained testosterone suppression below 50 ng/dL. 3 n.a. n.a. n.a.
n.a. mCRPC ARROW / Iodine-131 PSMA + Enzalutamide Met primary endpoint for PSA response (62.9% vs 31.3%). Radiographic PFS showed no significant difference, but Iodine-131 remains a viable targeting option. 2 n.a. n.a. 62.9
NCT05768139 mCRPC / nmHSPC STX-478 / PI3Kα inhibitor Mutant-selective PI3Kα inhibitor. Reduced toxicity (no hyperglycemia) compared to older PI3K drugs. Demonstrated 21% ORR across solid tumors. 1 n.a. n.a. n.a.
n.a. mHSPC ARASENS Post-hoc / Darolutamide PSA response Post-hoc analysis showing 67% reached undetectable PSA. Sustained low PSA levels strongly correlated with longer OS and delayed transition to mCRPC. 3 n.a. n.a. 67*
n.a. mHSPC ARASENS / Darolutamide + Docetaxel + ADT High-volume patients reached median rPFS of 43.7 months vs 19.1 months in control. Median OS was not reached in the darolutamide arm. 3 43.7* n.a. n.a.
n.a. mCRPC APEX-01 / ARX517 (PSMA ADC) ADC delivering microtubule inhibitor. 52% achieved PSA50 and 26% achieved PSA90 at higher dose levels. Highly favorable safety profile. 1/2 n.a. n.a. 52*
n.a. mHSPC ARANOTE / Darolutamide + ADT Chemotherapy-free triplet alternative. Showed 46% reduction in radiographic progression risk and 62.6% reached undetectable PSA (<0.2 ng/mL). 3 n.a. n.a. 62.6*