FK-PC101 as Adjuvant Therapy for Men With High-Risk Prostate Cancer
brief summary
The goal of this clinical trial is to learn if the vaccine FK-PC101 works to delay or prevent the return of prostate cancer in men who have had surgery to remove their prostate cancer. It will also learn about the safety of FK-PC101. The main questions it aims to answer are: Does FK-PC101 delay or prevent the return of prostate cancer following surgery? What medical problems do participants (subjects) have when taking FK-PC101? Researchers will compare FK-PC101 to current treatment practice to see if FK-PC101 works to prevent or delay the return of prostate cancer following surgery to remove the prostate cancer tumor. Subjects will: Have a sample of the prostate cancer tissue collected at the time of surgery to remove this tissue from the body. This tissue will then be used to create a personalized vaccine that is specific to your prostate cancer. If randomly selected to receive the vaccine, subjects will receive the vaccine up to 7 times over a 6-month period. In addition to the treatment visits for those randomized to receive FK-PC101, there will be up to 4 follow up visits to the clinic over a 22-month (nearly 2 year) period. For subjects randomized to receive current treatment practice, they will be asked to attend up to 8 visits over 22 months to track if there is any detectable cancer. Should their prostate cancer return within a year following surgery, they will be eligible to receive FK-PC101, which already had been produced and thus no additional tumor tissue would need to be obtained. Subjects in both study arms will have regular blood tests and scans to test whether their prostate cancer has returned.
detailed description
This is a multicenter, adaptive, Phase 2, randomized, open-label study designed to evaluate the efficacy of FK-PC101 adjuvant therapy in men with localized prostate cancer who have undergone radical prostatectomy (RP). Subjects will undergo a 3-step screening and enrollment process. Following an initial safety run-in that will include at least three subjects assigned to receive FK-PC101 vaccine and monitored closely for safety, subjects randomized to the vaccine group will receive up to 7 doses of FK-PC101, starting at 2 months post-RP. Subjects in the control group will receive standard-of-care. All subjects will have assessments at 60 days (2 months), 90 days (3 months) and 180 days (6 months) and then continue with follow-up visits at 10, 14, 18, and 22 months after randomization.
FK-PC101 is an autologous cellular vaccine, with each product being manufactured from a portion of tumor from each subject's prostatectomy specimen. The primary endpoint of DFS will be compared with the control group, who will also meet all eligibility criteria but who do not receive any postoperative adjuvant therapy.
Subjects will undergo a three-step eligibility process with criteria prior to RP, immediately following RP and 2 months post-RP/immediately prior to randomization.
Subjects will be randomized in a 1:1 open-label fashion to the vaccine group and the control group. Subjects will be stratified based on pathologic nodal status (pN0 vs. pN1). Subjects in the vaccine group will initiate vaccine dosing with up to 7 doses given between Day 1 and Day 180 (on Days 1, 8, 15, 22, 60, 90 and 180). Subjects randomized to the control group will be followed through 8 follow-up visits through month 22 (2 years post-surgery).
Following disease recurrence, all subjects may be treated with other prostate cancer therapies as deemed appropriate. Subjects in the control group will be eligible to receive their vaccine after disease recurrence has been documented. For subjects in the control group who elect to receive their vaccine, it must be started within 1 year of randomization. The vaccine doses may be administered prior to, during, or following other prostate cancer therapies but will follow the same schedule as for the subjects in the vaccine group.
official title
A Multicenter, Adaptive, Phase 2, Randomized, Open-label Study of Irradiated Autologous Cellular Vaccine in Men With High-Risk Prostate Cancer Following Prostatectomy