Final PEACE-3 Trial Data: Radium-223 + Enzalutamide Extends Survival by 5.6 Months in Bone mCRPC.

Radium-223 plus enzalutamide significantly boosts survival for men with metastatic castration-resistant prostate cancer (mCRPC) and bone metastases, according to final results from the Phase 3 PEACE-3 trial  presented at ASCO GU 2026. In this study of 446 patients with at least two bone metastases who were asymptomatic or only mildly symptomatic, adding six infusions of […]

EvoPAR-PR01: Saruparib (AZD5305) Phase III Trial in Metastatic Castration-Sensitive Prostate Cancer

Saruparib (AZD5305), a next-generation PARP1-selective inhibitor, represents a promising evolution in prostate cancer therapy, particularly for metastatic castration-sensitive disease (mCSPC), through the ongoing phase III EvoPAR-PR01 trial. Unlike first-generation PARP inhibitors (PARPi) such as olaparib that target both PARP1 and PARP2, saruparib specifically inhibits and traps PARP1 on DNA damage sites, sparing PARP2 to potentially […]

New Phase 3 Trial For BNT324 in Metastatic Castration-Resistant Prostate Cancer

BNT324 (DB-1311) is rapidly emerging as one of the most promising new agents in metastatic castration-resistant prostate cancer (mCRPC), with a data package that is unusually strong for a first-in-class B7-H3–targeting antibody–drug conjugate and now compelling enough to justify a head‑to‑head Phase 3 trial against docetaxel. The reason it has attracted so much attention is […]

Phase 3 Trial For Opevesostat A CYP11A1 Inhibitor in mCRPC

Opevesostat, a first-in-class CYP11A1 inhibitor, blocks the first step of steroid hormone production, eliminating all ligands that activate mutant androgen receptors in metastatic castration-resistant prostate cancer (mCRPC). The Phase 3 MK-5684-004 aka OMAHA-004 trial tests it against standard next-generation hormonal agents (NHAs, like abiraterone, enzalutamide, …) switching in 1,500 patients progressed on one prior NHA, […]

PT-112 Update: Phase 2 Biomarker Findings Pave Way for Phase 3 in End-Stage Prostate Cancer

Since FDA cleared PT-112 for a pivotal phase 3 trial in May 2025 (we talked about it here) following a successful end-of-phase-2 meeting, fresh insights illuminate why this novel platinum-based agent merits excitement for late-line metastatic castration-resistant prostate cancer (mCRPC). PT-112 stands apart from traditional platinums: its pyrophosphate structure drives osteotropism (high bone accumulation alongside […]

HRS-4357, a Novel PSMA-targeted Radiologand Therapy Phase 3 Trial

HRS-4357, a novel PSMA-targeted radiopharmaceutical, is poised to enter a landmark Phase III clinical trial targeting metastatic castration-resistant prostate cancer (mCRPC). The trial, received approval from China’s National Medical Products Administration on December 23, 2025, and plans to enroll 370 patients across multiple centers in China. This randomized, open-label, controlled study will directly compare HRS-4357 […]

Phase 3 InavoPC Trial of Inavolisib for mCRPC

A Phase 3 clinical trial is evaluating Inavolisib, a precision oncology drug, for men with metastatic castration-resistant prostate cancer (mCRPC).. The InavoPC trial offers a distinct approach: combining a PI3K inhibitor with continued hormonal therapy to address a fundamental biological mechanism of treatment resistance. Inavolisib is a highly selective inhibitor of the PI3Kα kinase enzyme. […]

UPDATE: ProstACT Global Phase 3 Trial for TLX591 Dosed The First Patient

ProstACT Global is a pivotal randomized Phase 3 study testing the PSMA-targeted radiopharmaceutical TLX591 (lutetium‑177 rosopatamab tetraxetan) in metastatic castration‑resistant prostate cancer. The trial has just moved into its randomized expansion phase, with the first patient in this part dosed at a specialized prostate cancer center in Melbourne, marking a key transition from safety/dosimetry work […]

Phase 3 Trial Evaluates Rezvilutamide vs Enzalutamide in mHSPC

A pivotal new Chinese phase 3 clinical trial is poised to begin recruiting patients with metastatic hormone-sensitive prostate cancer to compare two leading androgen receptor antagonists head-to-head: rezvilutamide (SHR3680) versus enzalutamide in mHSPC. This trial represents an important milestone in prostate cancer therapeutics by directly evaluating the efficacy and safety of these oral treatments in […]

A Phase 3 Study of Pasritamig Plus Docetaxel

Pasritamig is a bispecific T-cell engager that targets human kallikrein 2 (KLK2), a protein found primarily in prostate tissue and often retained in advanced prostate cancer. This drug brings T cells into close contact with KLK2-expressing tumor cells, directing immune responses against the cancer. In phase 1 studies, pasritamig was evaluated in men with metastatic […]