Phase 2 Study of FK-PC101 Vaccine as Additional Treatment for Men With High-Risk Prostate Cancer After Prostate Surgery

What this Trial Is About

Researchers are evaluating the vaccine FK-PC101 to see if it can delay or prevent the return of prostate cancer in men who have had surgery to remove their prostate tumor. This Phase 2, randomized, open-label trial compares FK-PC101 to current treatment practices in men with localized high-risk prostate cancer. The study also aims to learn about the safety of FK-PC101 and how it affects participants medically. In this study, men will have a sample of their prostate cancer tissue collected during surgery to create a personalized vaccine. Those randomized to the vaccine group will receive up to 7 doses of FK-PC101 over a 6-month period, starting 2 months after surgery. The vaccine doses are given intradermally and include the immune adjuvant BCG for the first two doses. Men in the control group will receive standard care without adjuvant therapy but may receive the vaccine if their cancer returns within a year after surgery. Participants will attend multiple clinic visits for treatment or follow-up over approximately 22 months. Regular blood tests and scans will monitor if the cancer returns. Researchers will assess disease-free survival as the primary outcome, along with time to next treatment, metastasis-free survival, immune response to FK-PC101, and safety. The study involves careful screening before surgery, post-surgery eligibility checks, and ongoing evaluations throughout the study period.

FK-PC101 as Adjuvant Therapy for Men With High-Risk Prostate Cancer