A Multicenter, Adaptive, Phase 2, Randomized, Open-label Study of Irradiated Autologous Cellular Vaccine in Men With High-Risk Prostate Cancer Following Prostatectomy
Cellvax Therapeutics Inc
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.
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-ca…
Eligibility
- Age range
- Not specified
- Sex
- Male
- Healthy volunteers
- No
Inclusion Criteria: * Has localized high-risk or very high-risk prostate cancer based on the NCCN v4.2023 classification. * Has ≥3 prostate biopsy cores with ≥50% tumor involvement. * Has PSA \>4 ng/mL ≤28 days prior to enrollment. * Has no evidence of distant metastases based on PSMA-PET/CT performed ≤28 days prior to enrollment. * Is a candidate for radical prostatectomy, and scheduled radical prostatectomy date must be 3 to 14 days after enrollment. * Has not received nor plans to receive neoadjuvant (preoperative) radiation therapy, androgen deprivation therapy (ADT), or any other antican…
Interventions
- BiologicalFK-PC101
Up to 7 doses of FK-PC101 will be administered intradermally between Day 1 and Day 180. The immune adjuvant Bacillus Calmette Guérin (BCG) will be given concurrently with Dose 1 (day 1) and Dose 2 (day 8).
- BiologicalStandard of Care (SOC)
Subject receives Investigator-defined standard of care, excluding adjuvant therapy. If prostate cancer recurs before 12 months after radical prostatectomy, subjects are eligible to receive up to 7 doses of intradermal FK-PC101 vaccine (first 2 given concurrently with BCG).
Locations (3)
- University of Chicago Medicine, High-Risk and Advanced Prostate Cancer ClinicChicago, Illinois
- Central Ohio Urology GroupGahanna, Ohio
- Carolina Urologic Research CenterMyrtle Beach, South Carolina