Yale Comprehensive Cancer Center

Isaac Y. Kim, MD, PhD, MBA, discusses cytoreductive radical prostatectomy (CRP). Despite advancements, the overall survival rate for metastatic prostate cancer (the incidence of which is rising in the U.S.) has only increased by four months since 2000. Dr. Kim cites the need for a paradigm change and posits that CRP may increase survival.

Dr. Kim describes a Phase I study on CRP showing a major complication rate of six percent as well as potential oncologic benefits. He cites a pilot study on patients receiving CRP and systemic therapy with some patients having durable responses long-term after CRP. Dr. Kim summarizes key lessons from the phase-one study, that CRP is feasible but difficult and the oncological outcome is promising, with three potentially different oncologic responses to CRP, with some patients experiencing PSA nadir <0.2 ng/ml, PSA decline but nadir remains 20.2 ng/ml, or disease progression. Dr. Kim turns to the SIMCAP (Surgery in Metastatic Carcinoma of Prostate) Phase-II.5 study with the hypothesis being that CRP will render systemic therapy more effective and enhance quality of life in men with metastatic prostate cancer. He reviews endpoints, inclusion criteria, and study design and explains the study is a 1:1 randomization of surgery and systemic therapy vs. systemic therapy alone. Dr. Kim emphasizes the study’s scientific value in addition to the study's clinical value, providing access to biospecimens early in the treatment cycle. He compares the SIMCAP and SWOG clinical trial S1802, explaining that SIMCAP is purely focused on surgery and doesn't include radiation and SIMCAP will have initial data more quickly than SWOG S1802. Dr. Kim summarizes by emphasizing CRP is safe and feasible, with a promising but uncertain therapeutic value, and the phase-two result on efficacy and quality of life is expected in two to four years.