Phase 1/2 Trial: Valemetostat Plus Darolutamide in mCRPC

A phase 1/2 clinical trial investigating valemetostat (DS-3201b), a dual EZH1/2 inhibitor, combined with darolutamide in metastatic castration-resistant prostate cancer (mCRPC) is going to start to recruit participants. This study aims to evaluate the safety, tolerability, and preliminary efficacy of the combination in men whose disease has progressed despite prior androgen receptor pathway inhibitors (ARPIs). […]

Phase 2 Trial For a New Triplet Therapy: SHR3680 (Rezvilutamide), HS-20093 and SHR2554

This Phase II study investigates the efficacy and safety of three investigational agents: SHR3680 (rezvilutamide), HS-20093, and SHR2554, aiming to enhance outcomes in metastatic prostate cancer through dual-pathway inhibition. SHR3680, a selective androgen receptor (AR) antagonist, represents the latest generation of hormonal therapy designed to inhibit the AR signaling axis, a critical driver of prostate […]

EVOLUTION Trial Ipilimumab And Nivolumab Plus 177Lu‑PSMA‑617 in mCRPC

Phase II EVOLUTION is a randomized study testing whether adding ipilimumab and nivolumab to 177Lu‑PSMA‑617 improves outcomes versus 177Lu‑PSMA‑617 alone in men with metastatic castration‑resistant prostate cancer (mCRPC). Early data presented in 2025 indicate that at 12 months, 33% of patients on the combination were free of progression versus 17% on 177Lu‑PSMA‑617 alone, signaling a […]

New Trial for AMO959 and Pluvicto and ARSI Combo

The ongoing phase Ib/II trial investigating the combination of AMO959, Pluvicto (lutetium-177 vipivotide tetraxetan, also known as AAA617 or 177Lu-PSMA-617), and androgen receptor pathway inhibitors (ARPIs) in metastatic castration-resistant prostate cancer (mCRPC) explores a novel approach targeting disease through multiple pathways. AMO959 is a direct activator of AMPK, a key metabolic regulator that can disrupt […]

Pacritinib in Participants With mCRPC Expressing Stat5 (POSTPONE)

To join the phase 2 POSTPONE trial investigating pacritinib for advanced prostate cancer, patients must have metastases that are strongly positive for STAT5 activation—specifically, a recent tumor biopsy must show detectable nuclear STAT5 in more than 5% of cancer cells.​ This trial is built upon robust laboratory and clinical findings showing that the JAK2-STAT5 pathway […]

Low‑Dose Naltrexone for ADT‑Related Fatigue in Prostate Cancer

A new trial will test whether nightly low‑dose naltrexone (3 mg) reduces fatigue in men with prostate cancer receiving androgen‑deprivation therapy (ADT), while concurrently profiling mitochondrial, inflammatory, and oxidative stress pathways that may drive cancer‑related fatigue in this setting. The single‑arm University of Arkansas study plans to enroll 60 men over 30 months, using FACIT‑F […]

UPDATE 2: HLD-0915 Shows Promising Early Results in Drug-Resistant Prostate Cancer

A first-in-human clinical trial conducted at The University of Texas MD Anderson Cancer Center has revealed encouraging early results for HLD-0915, a new oral therapy designed for patients with metastatic castration-resistant prostate cancer (mCRPC). The findings, presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, indicate that HLD-0915 is well tolerated and […]

UPDATE About ENV-105: Promising Phase 2 Interim Results for mCRPC

The investigational drug ENV-105 (carutoximab), a first-in-class CD105 antagonist, has shown promising interim efficacy results in a Phase 2 clinical trial involving patients with metastatic castration-resistant prostate cancer (mCRPC) who have progressed after standard hormone therapies. This ongoing trial evaluated the combination of ENV-105 with apalutamide, a commonly used hormone therapy. Among patients treated, 86% […]

Phase 1/2 Trial to Evaluate Gedatolisib Plus Darolutamide Combo in mCRPC

Gedatolisib, an inhibitor targeting the PI3K/AKT/mTOR pathway, in combination with darolutamide, an androgen receptor antagonist, is being evaluated as a treatment option for metastatic castration-resistant prostate cancer (mCRPC). In a phase 1/2 clinical trial, patients who had progressed on prior androgen receptor signaling inhibitors received once-weekly intravenous gedatolisib in doses of 120 mg or 180 […]

Phase 1/2 AlphaBet Trial: Promising Combination of Lutetium-177 PSMA-I&T and Radium-223 in Advanced Prostate Cancer

A novel therapeutic approach combining lutetium-177 177Lu-PSMA-I&T and radium-223 (223Ra) shows encouraging results for men with metastatic castration-resistant prostate cancer (mCRPC), as demonstrated in the recently reported AlphaBet trial published in The Lancet Oncology in October 2025. This phase 1/2 AlphaBet study is the first to evaluate the safety, feasibility, and preliminary efficacy of the […]