Phase 1/2 Trial: Epigenetic KAT6 Inhibitor Plus Darolutamide in mCRPC

A Phase 1b/2 trial is planned to test the investigational KAT6 inhibitor OP-3136 combined with darolutamide in metastatic castration-resistant prostate cancer (mCRPC). About 36 patients will be enrolled, with the study expected to start in the second half of 2026. The focus is on safety, tolerability, and early signs of anti-tumor activity. OP-3136 blocks KAT6A/B, […]

A-DREAM Trial Suggests Some Men with Metastatic Prostate Cancer May Stop Therapy Safely for a Time

A new phase 2 study, A-DREAM / Alliance A032101, suggests that a carefully selected group of men with metastatic hormone-sensitive prostate cancer may be able to interrupt androgen deprivation therapy and an androgen receptor pathway inhibitor after achieving an excellent response, while still maintaining a treatment-free interval. The study met its primary endpoint, with 41% […]

Phase 2 TALENT Trial: Talazoparib as Monotherapy or With Enzalutamide in HRR-deficient mCRPC

The TALENT trial is a randomized, open‑label, phase 2 trial evaluating whether adding enzalutamide to talazoparib improves outcomes compared with talazoparib alone in men with metastatic castration‑resistant prostate cancer (mCRPC) who have homologous recombination repair (HRR) gene alterations and have progressed after abiraterone‑based therapy. The trial builds on the phase 3 TALAPRO‑2 results, which showed […]

ABBV-969 in mCRPC: Dual‑Targeting ADC Shows Robust PSA and Objective Responses in Heavily Pretreated Patients

ABBV-969, a first-in-class dual-targeting antibody-drug conjugate (ADC), is emerging as a promising new therapeutic candidate for patients with metastatic castration-resistant prostate cancer (mCRPC), particularly in the late-line setting where treatment options are limited and outcomes remain poor. Designed to simultaneously target prostate-specific membrane antigen (PSMA) and six-transmembrane epithelial antigen of prostate 1 (STEAP1), both highly […]

CONVERGE-01: CONV01-α Shows Activity After Lu-PSMA in mCRPC

Actinium-225 rosopatamab tetraxetan (CONV01-α) is a PSMA-targeted alpha radioligand therapy being tested in men with metastatic castration-resistant prostate cancer who have already received androgen receptor pathway inhibitors, up to one taxane regimen, and 1–6 cycles of lutetium-177 PSMA therapy (Pluvicto), with all patients having PSMA PET–positive disease by VISION criteria. The drug links an alpha […]

Overcoming AR Mutations in Prostate Cancer: Phase 1 Results of HRS-5041

A new investigational drug, HRS-5041, may offer a compelling strategy to overcome resistance to androgen receptor (AR)-targeted therapies.. Unlike traditional AR inhibitors, HRS-5041 is an oral androgen receptor degrader designed to eliminate the receptor itself, including clinically relevant mutant forms. In a phase 1, 156 patients with mCRPC were treated with HRS-5041. All patients had […]

BAT Before Sipuleucel-T in mCRPC: Immune Priming?

Bipolar androgen therapy (BAT) given before sipuleucel‑T appears to increase the rate and magnitude of PA2024‑specific immune responses in men with metastatic castration‑resistant prostate cancer (mCRPC), compared with historical sipuleucel‑T data. The central interpretation is not that BAT by itself generates this immune response, but that BAT may prime the tumor and immune environment so […]

Darolutamide Linked to Cognitive Benefit Over Enzalutamide in Prostate Cancer

Darolutamide (Nubeqa) caused significantly less cognitive decline than enzalutamide (Xtandi) over 24 weeks in men with advanced prostate cancer, according to results from the phase 2 ARACOG trial, which are scheduled to be presented at the 2026 ASCO Annual Meeting. The findings represent the first randomized, prospective head-to-head comparison of the cognitive effects of two […]

Phase 3 PSMAddition Trial Reports Positive Outcomes for mHSPC

Results from the PSMAddition trial were published in a phase 3 setting and showed several clear numbers worth noting. The trial compared standard double hormone-based treatment alone (ADT + ARPI) versus the same treatment plus a PSMA-targeted radioligand therapy (Pluvicto), in men with metastatic hormone-sensitive prostate cancer.The biggest headline was a 58% lower risk of […]

ARASEC Trial Validates Darolutamide Plus ADT in Metastatic Hormone-Sensitive Prostate Cancer

The ARASEC trial, offers compelling evidence for darolutamide combined with androgen deprivation therapy as a treatment option for men with metastatic hormone-sensitive prostate cancer. This Phase 2 study tackled a challenging ethical dilemma in modern clinical trial design: how to evaluate a new treatment when randomizing patients to receive only standard ADT would be considered […]