Michael J. Morris, MD, discusses findings from the phase 2 TheraP study, and how they led to the development of the phase 3 VISION trial in metastatic castration-resistant prostate cancer.
Michael J. Morris, MD, medical oncologist, section head, Prostate Cancer, GU Oncology, Memorial Sloan Kettering Cancer Center, discusses findings from the phase 2 TheraP study (NCT03392428), and how they led to the development of the phase 3 VISION trial (NCT03511664) in metastatic castration-resistant prostate cancer (mCRPC).
The TheraP study was the first randomized trial to evaluate the potential anticancer activity of Lutetium 177 (177Lu) PSMA-617 (177Lu-PSMA-617) vs cabazitaxel (Jevtana) in men with mCRPC, Morris says. The study did not include overall survival (OS) as the primary end point, but rather prostate-specific antigen (PSA) response rate, Morris says. The study demonstrated that 177Lu-PSMA-617 resulted in a higher PSA response rate compared with cabazitaxel in the second-line setting for this patient population, Morris explains.
The results of the TheraP trial led to the development of the VISION trial because TheraP did not set OS as a clinical end point, Morris continues. Therefore, VISION moved 177Lu-PSMA-617 further in development by demonstrating OS and progression-free survival improvement with the radiopharmaceutical compared with standard of care in men with mCRPC, Morris concluded.