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 […]

Phase 1/2 PETRANHA Trial Update: Promising Results Reported at ESMO 2025

At the 2025 ESMO Congress, new data from the phase 1/2 PETRANHA trial introduced saruparib (AZD5305), a highly selective PARP1 inhibitor, as a potentially safer and more effective therapeutic partner for androgen receptor pathway inhibitors (ARPIs) in metastatic prostate cancer. The results highlighted a strong efficacy signal in castration-sensitive disease and ARPI-naïve castration-resistant settings, while […]

Phase 2: Copper-Based PET Imaging Agent Surpasses Standard Tracer for Early Prostate Cancer Lesion Detection

The phase 2 Co-PSMA trial conducted at St Vincent’s Hospital in Sydney evaluated 64Cu-SAR-bisPSMA, a novel copper-based PET imaging agent, against the standard 68Ga-PSMA-11 tracer in patients with biochemical recurrence of prostate cancer and low PSA levels. Results showed 64Cu-SAR-bisPSMA detected a statistically greater number of PSMA-positive lesions per patient than the standard agent, particularly […]

Phase 2 Trial: Optimal PSA-Triggered Intermittent Therapy for mHSPC

This Phase II study explores a novel approach to treating metastatic hormone-sensitive prostate cancer (mHSPC) through PSA-triggered intermittent therapy. Traditionally, men with mHSPC are managed with continuous androgen deprivation therapy (ADT) in combination with androgen receptor pathway inhibitors (ARPIs). This strategy has significantly extended survival but often leads to enduring side effects such as fatigue, […]

Phase 1/2 Study: New Combination Therapy Combines Tulmimetostat (DZR123) and JSB462 (aka Luxdegalutamide aka ARV-766)