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 […]

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 […]

Targeted Alpha Therapy Plus PARP Blockade: AZD2265 plus AZD9574 for Advanced Prostate Cancer

There is a new flexible trial for men with metastatic prostate cancer that has stopped responding to hormone therapy. Phase 1/2 PROSPECTOR trial tests three options: a PSMA‑targeted radioactive drug (AZD2265), the same drug combined with a PARP1 inhibitor (AZD9574), and standard docetaxel chemotherapy. The first part of the trial finds safe dose levels and […]

Phase 1/2 Trial for GDC‑1261 in Advanced Prostate Cancer

GDC‑1261 is a new study drug being tested in men with advanced or metastatic prostate cancer in a first‑in‑human Phase 1/2 trial. The public description of the study states that the main goals are to evaluate the safety profile, pharmacokinetics, and preliminary anti‑tumor activity of GDC‑1261 and to identify a recommended dose and dosing schedule […]

Phase 1/2 Update: Concurrent Enzalutamide–Cabazitaxel Produces Durable PFS Signal in mCRPC

The updated Phase 1/2 data for concurrent enzalutamide plus cabazitaxel in chemo‑naïve mCRPC show deep biochemical responses and a promising signal for progression‑free outcomes, but the dataset remains hypothesis‑generating. In a multi‑institutional single‑arm trial of enzalutamide with cabazitaxel (plus prednisone), 35 patients were included in the efficacy analysis with a median follow‑up of 23.7 months; […]

TLX597-Tx Shows Early Promise in a Phase 2 PSMA Trial for Prostate Cancer

TLX597-Tx (177Lu-DOTA-HYNIC-panPSMA) is emerging as a next-generation PSMA-targeted radioligand therapy designed to deliver radiation more precisely to prostate cancer cells while limiting exposure to healthy organs. New data from the OPTIMAL-PSMA trial suggest that the drug may achieve strong tumor uptake with relatively low dose to the salivary glands and kidneys, two of the main […]

Phase 2 ARTEMIS-003 Trial: HS-20093 for mCRPC

HS-20093  has received Breakthrough Therapy designation from China’s National Medical Products Administration for metastatic castration-resistant prostate cancer. The designation covers patients previously treated with novel endocrine therapy and taxane-based chemotherapy, a setting where later-line treatment options remain limited. HS-20093 is a B7-H3-targeted antibody-drug conjugate designed to bind tumor cells expressing B7-H3 and deliver a cytotoxic […]

Phase 1/2 RAISIC‑1 Trial: PTT‑4256 in Advanced Solid Tumors

PTT‑4256 is an emerging first‑in‑class small‑molecule inhibitor of GPR65, a proton‑sensing G‑protein‑coupled receptor selectively expressed on immune cells within the acidic tumour microenvironment. It is being evaluated in the RAISIC‑1 trial, a modular, open‑label, phase 1/2 study in patients with advanced solid tumours designed to assess safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy. The trial’s […]

Phase 1/2 Trial for AZD8359: a CD8-Biased T Cell Engager Targeting STEAP2 in m CRPC

Bispecific T cell engagers, while conceptually powerful, have carried a toxicity profile that constrains their clinical utility. AZD8359, a novel trispecific T cell engager now entering its first-in-human clinical trial, represents a thoughtful attempt to resolve that toxicity problem at the molecular engineering level, and its preclinical data are among the most compelling seen in this […]