Dr. Pieczonka on the Design of the Phase 3 VERACITY Trial With VERU-111 in mCRPC

Christopher Pieczonka, MD, director of clinical research at Crouse Health, discusses the design of the phase 3 VERACITY trial (NCT04844749) studying VERU-111 (Sabizabulin) in patients with metastatic castration-resistant prostate cancer (mCRPC).

A dose of 63 mg of VERU-111 is going to be used in the phase 3 study, which was the same dose used in the phase 2 study (NCT03752099), according to Pieczonka. The double-blinded trial will enroll approximately 245 patients who will be randomized 2:1 to either oral VERU-111 or placebo.

The primary of end point of the trial will be radiographic progression-free survival, with key secondary end points including overall response rate and overall survival, Pieczonka explains. The treatment is being examined as a possible alternative to standard of care intravenous chemotherapy regimens, he says. As patients are living longer on original model hormonal agents, a group of patients are being cultivated who are young and healthy enough to take another step in treatment with VERU-111 before moving on to more toxic additional therapies, Pieczonka concludes.