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.
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.
Has an additional active malignancy that may confound the assessment of the study endpoints. If the subject has a past cancer history (active malignancy within 2 years prior to study entry) with substantial potential for recurrence, this must be discussed with the Sponsor before study entry. Note: Subjects with the following concomitant neoplastic diagnoses are eligible: non-melanoma skin cancer and carcinomas in situ (including breast DCIS, transitional cell carcinoma/NMIBC, anal carcinoma, and melanoma in situ).
Is eligible for and elects to receive adjuvant therapy following RP.
Has clinically significant cardiovascular disease (e.g., uncontrolled or any New York Heart Association [NYHA] Class 3 or 4 congestive heart failure, uncontrolled angina, history of myocardial infarction, unstable angina, pulmonary embolism or stroke within 6 months prior to study entry, uncontrolled hypertension, or clinically significant arrhythmias not controlled by medication).
Has uncontrolled, clinically significant pulmonary disease (e.g., chronic obstructive pulmonary disease, pulmonary hypertension) that in the opinion of the Investigator would put the subject at significant risk for pulmonary complications during the study.
Crossover
FK-PC101
Biological/VaccineUp 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).
Standard of Care (SOC)
Biological/VaccineSubject 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).
Disease-free survival (DFS)
DFS is defined as local prostate cancer recurrence, distant metastatic prostate cancer recurrence, biochemical recurrence of PSA, or death from any cause
Time to next treatment (TTNT)
Time from randomization until disease recurrence or receipt of any form of adjuvant or salvage radiotherapy, hormonal therapy including ADT, or any other form of prostate cancer therapy post-randomization
Metastasis-free survival (MFS)
Time from date of randomization to the 1st evidence of distant metastatic prostate cancer recurrence as detected by PSMA-PET/CT or other imaging performed, or to death from any cause
Immune response to FK-PC101
Immune response to FK-PC101 as measured by ELISpot assay (FK-PC101 arm only)
Safety and tolerability of FK-PC101
Frequency and severity of AEs per the NCI-CTCAE version 5.0
Overall survival (OS)
Time from date of randomization to date of death due to any cause
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