The FDA announced on February 18, 2026, that it will no longer require two pivotal clinical trials for new drug approvals, establishing a single-trial approach as the default standard. In a New England Journal of Medicine perspective, FDA leaders argued that the “two-trial dogma”, unchallenged since the 1960s, is obsolete given advances in biology, statistical […]
Researchers at Case Western Reserve University used tiny ultrasound-activated nanobubbles to dismantle the tough collagen walls that shield solid tumors from treatments. These “fortresses” made of stiff, crosslinked collagen block immune cells and drugs from reaching cancer cells deep inside, a major hurdle in fighting aggressive tumors like prostate cancer. The nanobubbles, filled with inert […]
A promising Phase 1/2 clinical trial is investigating SHR-4394, a selective CDK4/6 inhibitor, combined with anti-tumor therapies such as rezvilutamide, HRS-5041, or tazemetostat in men with metastatic prostate cancer. CDK4/6 inhibitors like SHR-4394 block a key pathway that makes prostate cancer cells grow out of control. This pathway uses proteins called cyclin D, CDK4/6, and […]
A first-in-human Phase 1 clinical trial is underway to evaluate BG-C0979, a novel antibody-drug conjugate (ADC) designed for adults with advanced solid tumors. This open-label study focuses on assessing the drug’s safety, tolerability, pharmacokinetics, and early signs of antitumor activity through dose escalation and potential expansion phases. BG-C0979 targets ADAM9, a disintegrin and metalloproteinase enzyme […]
The ACRES trial represents a promising step forward in targeted alpha therapy for metastatic castration-resistant prostate cancer (mCRPC), focusing on Actinium-225-labeled radiohybrid PSMA-10.1 (225Ac-rhPSMA-10.1) in patients who have largely progressed after Lutetium-177 PSMA therapy. This multi-site, open-label Phase 1/2 study addresses an urgent need in advanced prostate cancer, where effective post-Lu-PSMA options remain limited despite […]
EBNK-001 represents a promising advancement in cancer immunotherapy as an “off-the-shelf” allogeneic natural killer (NK) cell product designed for multi-dose administration in patients with advanced solid tumors. Unlike autologous therapies that require individual patient cell harvesting and processing, EBNK-001 leverages healthy donor-derived NK cells, enabling immediate availability without lengthy manufacturing delays. This off-the-shelf approach addresses […]
Saruparib (AZD5305), a next-generation PARP1-selective inhibitor, represents a promising evolution in prostate cancer therapy, particularly for metastatic castration-sensitive disease (mCSPC), through the ongoing phase III EvoPAR-PR01 trial. Unlike first-generation PARP inhibitors (PARPi) such as olaparib that target both PARP1 and PARP2, saruparib specifically inhibits and traps PARP1 on DNA damage sites, sparing PARP2 to potentially […]
LAST WEEK TODAY! A summary of what was published on ProstateWarriors.com during the past week Hi fellow warriors! The week has been very quiet, but that was to be expected since a major genitourinary oncology conference is coming up in about ten days. Still, I’m expecting news very soon! Stay strong and fight on! As usual, we […]
A new phase 2b clinical trial has received FDA “study may proceed” clearance for teverelix, a long‑acting GnRH antagonist being evaluated in men with advanced prostate cancer who are at high cardiovascular risk. The trial is designed to test a dose‑optimization regimen of teverelix over a 22‑week treatment period, with the primary goal of confirming […]
A study used prostate tissue from patients who had undergone surgery, some of whom later relapsed and some of whom remained cancer-free many years afterward. By comparing these two groups, the research team could define which samples represented aggressive disease and then search for molecular features that consistently separated them from indolent tumors. The original […]