Christopher Pieczonka, MD, director of clinical research, Crouse Health, discusses the rationale to evaluate sabizabulin (VERU-111) in men with metastatic castration-resistant prostate cancer (mCRPC) in the phase 3 VERACITY trial (NCT04844749).

The rationale to evaluate VERU-111 in mCRPC was based on the hypothesis that oral chemotherapy could benefit patients who are likely to respond to intravenous (IV) chemotherapy, explains Pieczonka. IV chemotherapy is efficacious, but it is not targeted against a specific genetic abnormality, Pieczonka says. 

Historically, docetaxel was the standard IV chemotherapy used in mCRPC, Pieczonka adds. The drug is given in a high dose so that patient doesn’t have to come in for daily infusions, Pieczonka continues. Therefore, the patient receiving docetaxel can benefit for several weeks before requiring additional therapy. However, IV chemotherapy is associated with toxicities, such as neutropenia and neuropathy, Pieczonka adds. 

 Overall, oral chemotherapy could elicit similar therapeutic effects vs IV chemotherapy, Pieczonka says. However, by daily dosing with the oral medication, those toxicities may be mitigated, Pieczonka concludes. 

Videos

Christopher Pieczonka, MD, discusses the rationale to evaluate sabizabulin in men with metastatic castration-resistant prostate cancer in the phase 3 VERACITY trial.

Dr. Pieczonka on the Rationale to Evaluate 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.

Christopher Pieczonka, MD, discusses the design of the phase 3 VERACITY trial studying VERU-111 in patients with metastatic castration-resistant prostate cancer.

Christopher Pieczonka, MD

Articles

Dr. Pieczonka on the Rationale to Evaluate VERU-111 in mCRPC

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