Pluvicto Moves Into First-Line Metastatic Prostate Cancer, Marking Shift Toward Earlier Radioligand Therapy

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A new regulatory approval is reshaping the treatment landscape for metastatic hormone-sensitive prostate cancer (mHSPC), bringing radioligand therapy into much earlier stages of disease. Pluvicto (lutetium Lu-177 vipivotide tetraxetan aka 177Lu-PSMA-617), a therapy targeting prostate-specific membrane antigen (PSMA), can now be used in combination with standard androgen deprivation therapy and androgen receptor pathway inhibitors in […]

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Phase 2 Trial for Xaluritamig in Patients With mCRPC and Suboptimal Response to Pluvicto

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Thomas Jefferson University is running a phase 2 study of xaluritamig, also known as AMG 509, in adults with metastatic castration-resistant prostate cancer whose disease has shown a suboptimal response to Lu-177 vipivotide tetraxetan (aka 177Lu-PSMA 617) the radioligand therapy better known as Pluvicto. The trial reflects a very specific and clinically important question: what […]

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Phase 1 Trial for ASP388B

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ASP388B is an experimental anticancer drug now being tested in a first-in-human study for people with advanced solid tumors, including mCRPC. The public trial record shows it is being studied both alone and in combination with standard treatments, but its exact molecular target has not been publicly disclosed in the materials I could verify. In […]

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UPDATE: FX-111 Entered Clinical Trials Phase

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The first-in-human Phase 1 trial is designed to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics and early signs of anti-tumor activity for FX-111 just started recruiting. We already talked about the rationale behind it in this post. FX-111 is a selective degrader of ARon, the transcriptionally active, hormone-bound form of the androgen receptor. That distinction matters because […]

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Mitochondrial Fitness and Endurance May Help Men With Prostate Cancer Tolerate Androgen Deprivation Therapy Better

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A study published in Nature Communications, “Muscle mitochondria, function, mass, and quality of life in prostate cancer during androgen deprivation therapy,” looked at how muscle health affects men with advanced prostate cancer during androgen deprivation therapy. The researchers followed 60 patients over six months and assessed body composition, strength, endurance, quality of life, and skeletal […]

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UPDATE: VIR-5500 Extended into mHSPC

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VIR-5500 expanded into mHSPC in April 2026, when it announced the first patient had been dosed in the Phase 1 dose-expansion cohorts. VIR-5500 is being studied in late-line mCRPC as monotherapy and, importantly for this expansion, in combination with an androgen receptor pathway inhibitor in early-line mCRPC and mHSPC. The move was built on earlier […]

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UPDATE: SL-28 Phase 1/2 Trial Started To Recruit in Advanced Solid Tumors

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A very interesting Phase 1/2 trial of SL‑28 has started enrolling up to 60 patients with advanced solid tumours at The Southern Oncology Clinical Research Unit (SOCRU). Although the study is open to a broad range of solid cancers, it is particularly noteworthy for prostate cancer because a published case report described a complete response […]

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EvoPAR‑Prostate05 Phase 3 Trial: Saruparib Maintenance for Metastatic Hormone‑Sensitive Prostate Cancer

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EvoPAR‑Prostate05 is a Phase 3 maintenance trial testing the PARP1‑selective inhibitor saruparib (AZD5305) in men with metastatic hormone‑sensitive prostate cancer (mHSPC). The trial enrolls both HRR‑mutated and non‑HRR‑mutated patients but requires that each participant has confirmed homologous recombination repair mutation status (HRRm – genes such as BRCA1, BRCA2, ATM, PALB2, CDK12, RAD51B/C/D, or BARD1), homologous […]

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Phase 2 Trial: Adaptive PSMA-PET–Guided 177Lu-DOTA-HYNIC-panPSMA (TLX597-Tx) in mHSPC

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The OPTIMAL-e trial is a phase 2 pilot study testing adaptive, PSMA-PET–guided radioligand therapy (RLT) with 177Lu-DOTA-HYNIC-panPSMA (TLX597-Tx) in men with metastatic hormone-sensitive prostate cancer (mHSPC), on top of standard androgen deprivation therapy (ADT) and an androgen receptor pathway inhibitor (ARPI). Conducted at St Vincent’s Hospital in Sydney, it is single-arm, open-label, and nonrandomized, designed […]

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Phase 1 Trial of SHY-ONC6, a Proteasome-Modulating Therapy in Solid Tumors (Including mCRPC)

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SHY-ONC6 is now entering a Phase 1 first-in-human clinical study in patients with advanced or metastatic solid tumors. The trial is open-label and multicenter, and its main goals are to assess safety, tolerability, pharmacokinetics, and early signs of anti-tumor activity in people whose disease has progressed on standard therapy or who cannot tolerate it. SHY-ONC6 […]

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