OncoMatch/Clinical Trials/NCT06636682
FK-PC101 as Adjuvant Therapy for Men With High-Risk Prostate Cancer
Is NCT06636682 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including FK-PC101 and Standard of Care (SOC) for prostate cancer (adenocarcinoma).
Treatment: FK-PC101 · Standard of Care (SOC) — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Disease stage
Required: Stage >PT3A, PT3B, PT4 (pathologic (post-prostatectomy))
Grade: Gleason score 8Gleason score 9Gleason score 10Gleason sum 7 (4+3) if pT3b or pT4 (Gleason)
Stage >pT3a (tumor has extended outside of the prostate on one side). Gleason score of 8, 9, or 10 (high/very high) on prostatectomy specimen. Subjects with pT3b or pT4 tumors with a Gleason sum 7 (4+3) are eligible.
Prior therapy
Cannot have received: radiation therapy
Has not received nor plans to receive neoadjuvant (preoperative) radiation therapy
Cannot have received: androgen deprivation therapy
Has not received nor plans to receive neoadjuvant (preoperative) androgen deprivation therapy (ADT)
Cannot have received: anticancer therapy
Has not received nor plans to receive neoadjuvant (preoperative) ... or any other anticancer therapy
Cannot have received: postoperative or adjuvant XRT
No prior, current, or planned future postoperative or adjuvant XRT
Cannot have received: hormonal therapy such as ADT
No prior, current, or planned future ... hormonal therapy such as ADT
Cannot have received: anticancer therapy
No prior, current, or planned future ... any other anticancer therapy
Lab requirements
Blood counts
ANC >1000/µL; platelet count >100,000/µL; hemoglobin >8.0 gm/dL
Kidney function
eGFR >60 mL/minute based on Cockcroft-Gault formula
Liver function
AST and ALT both <2 × upper limit of normal (ULN); albumin >3.0 gm/dL
Adequate organ function based on CBC and chemistry studies within 2 weeks of Day 1 (Day -14 to -7). Specific laboratory requirements include: Absolute neutrophil count (ANC) >1000/µL; Platelet count >100,000/µL; Hemoglobin >8.0 gm/dL; Estimated glomerular filtration rate (eGFR) >60 mL/minute based on Cockcroft-Gault formula; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) both <2 × upper limit of normal (ULN); Albumin >3.0 gm/dL.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Chicago Medicine, High-Risk and Advanced Prostate Cancer Clinic · Chicago, Illinois
- Central Ohio Urology Group · Gahanna, Ohio
- Carolina Urologic Research Center · Myrtle Beach, South Carolina
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