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 […]

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 […]

GenSci143: A Dual-Target ADC Emerging for Metastatic Prostate Cancer

GenSci143 (aka GenSci-143) is a bispecific antibody-drug conjugate under development for metastatic castration-resistant prostate cancer (mCRPC) and other solid tumors. The construct targets B7-H3 (CD276) and PSMA simultaneously with a bispecific antibody, coupled via a stable, cleavable linker to a topoisomerase I inhibitor payload, aiming to improve tumor cell killing and bystander effects across heterogeneous […]

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 […]

177Lu-PSMA-617 (Pluvicto) Combo With Sipulecel-T in Phase 1 Trial

City of Hope Medical Center, in collaboration with the National Cancer Institute, is initiating a randomized phase 1 study in metastatic castration‑resistant prostate cancer (mCRPC) that compares lutetium Lu 177 vipivotide tetraxetan (177Lu‑PSMA‑617 or Pluvicto) alone versus the same radioligand combined with sipuleucel‑T, with the primary goal of quantifying the induced anti‑tumor immune response alongside […]

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 […]

Final OS Data from EMBARK Phase 3 Trial: Enzalutamide With ADT for Men at Risk of BRPC

Data from the phase 3 EMBARK trial, combining enzalutamide with standard hormone therapy, recently published in The New England Journal of Medicine and presented at the 2025 European Society for Medical Oncology (ESMO) Congress, reveal that this combination reduces the risk of death by more than 40% over eight years compared to hormone therapy alone. […]

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 […]