Phase 1 Trial: 177Lu-PSMA-617 Plus Darolutamide in High-Risk Localized Prostate Cancer

A new trial phase 1 trial is investigating the combination of 177Lu-PSMA-617 (Pluvicto) with darolutamide in high-risk localized prostate cancer. Both agents are already established in prostate cancer care, but using them together before surgery is a novel way to intensify treatment in patients whose disease is still potentially curable. Its main idea is simple: […]

GRPR-Targeted Radioligand Therapy in Prostate Cancer: The A9-0631 and A9-0642 Trial

A new first-in-human study is testing whether GRPR-targeted radiopharmaceuticals can extend precision oncology beyond the PSMA and SSTR frameworks. The trial combines two therapeutic agents, 177Lu-A9-0631 and 225Ac-A9-0642, with GRPR imaging using 68Ga-A9-6217 or low-dose 177Lu-A9-0631 in patients with GRPR-positive solid tumors. GRPR, or gastrin-releasing peptide receptor, is an appealing target because it is overexpressed […]

ARTO Trial Final Results: Long-Term Survival Benefit of SBRT Added to Abiraterone in Oligometastatic mCRPC

The phase 2 ARTO trial findings, published on The Lancet, provides stronger evidence that metastasis-directed SBRT can improve outcomes in oligometastatic castration-resistant prostate cancer. In this randomized study, 157 patients were enrolled across 16 academic and community centers in Italy and assigned 1:1 to abiraterone plus ADT with or without SBRT to all visible metastatic […]

Bavdegalutamide Plus Abiraterone in Metastatic Prostate Cancer: Phase Ib Safety and Activity Results

Bavdegalutamide (ARV-110) is an oral androgen receptor degrader designed to address resistance to androgen-receptor–targeted therapy in metastatic prostate cancer. In this phase 1b study, it was combined with abiraterone in patients whose disease was progressing on abiraterone, with the goal of testing safety, pharmacokinetics, and early signs of antitumor activity. The trial enrolled 45 patients, […]

Another Phase 1/2 Trial With SX-682, Combined With Docetaxel This Time

SX-682 is moving into a new clinical context. After an ongoing trial in prostate cancer with androgen receptor pathway inhibitors such as apalutamide and enzalutamide, the CXCR1/2 inhibitor is now being studied with docetaxel in recurrent/metastatic head and neck squamous cell carcinoma, salivary gland carcinoma, and advanced prostate cancer. That matters because docetaxel is not […]

Phase 1 Trial for a New PSMA Radioligand 177Lu‑PSMA‑VG01

177Lu‑PSMA‑VG01 is a next‑generation, small‑molecule PSMA‑targeting radiopharmaceutical designed to refine what 177Lu‑PSMA‑617 (Pluvicto) has already achieved. It uses a high‑affinity ligand to deliver the beta‑emitter lutetium‑177 directly to PSMA‑expressing tumor cells, aiming for greater tumor dosing with less exposure of healthy tissue. A new phase 1 trial is testing its dosimetry and side effects on […]

Dual-Targeting PSMA And FRα Drug Conjugate Advances to U.S. Trial for Prostate Cancer

MVB-101 (aka CBP-1018) is a new clinical-stage drug conjugate for prostate cancer simultaneously targets PSMA and folate receptor alpha (FRα) to overcome tumor heterogeneity. The drug is a bivalent peptide-like drug conjugate roughly one-fiftieth the size of a traditional antibody drug conjugate, designed to diffuse more rapidly into solid tumors. It delivers monomethyl auristatin E […]

Phase 1 RIALTO Trial: Radiotherapy for Metastatic Prostate Cancer With Incomplete Hormone Response

The RIALTO trial challenges decades of oncology dogma that treating the prostate becomes irrelevant once cancer spreads. For patients with de novo metastasized prostate cancer who show incomplete PSA-response (PSA >0.2 ng/ml after six months of combined ADT+ARPI), the prostate may function as a persistent tumor reservoir continuously seeding metastases. Local radiotherapy to the prostate […]

Phase III PrTK03 Trial Results: Aglatimagene Besadenovec (CAN-2409) Improves Survival in Localized Prostate Cancer

The phase III PrTK03 trial, reported in The Lancet Oncology, demonstrates that adding aglatimagene besadenovec (CAN-2409) plus valacyclovir to standard radiotherapy improves disease-free survival in patients with localized prostate cancer. Aglatimagene is an intratumoral adenoviral gene therapy that delivers the HSV-tk gene, enabling tumor cells to convert the prodrug valacyclovir into a cytotoxic metabolite that […]

Phase 2 Trial for 61Cu-NU101 vs 18F-Piflufolastat in Metastatic Prostate Cancer

61Cu-NU101 is a new PSMA-targeted PET/SPECT tracer for prostate cancer that showed promise in phase 1, detecting more lesions than 18F-piflufolastat (Pylarify) in half of the 8 patients studied, with lower background uptake and no side effects. The key advantage is its 3.3-hour half-life, compared to 68 minutes for 68Ga-PSMA-11 and 109 minutes for 18F-piflufolastat. […]