NCT06636682 · Cellvax Therapeutics Inc
FK-PC101 as Adjuvant Therapy for Men With High-Risk Prostate Cancer
What this study is about
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.
View original scientific description
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.
Interventions
BIOLOGICAL
FK-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).
BIOLOGICAL
Standard 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).
Primary outcome measures
Disease-free survival (DFS)
Time frame: Up to approximately 22 months
DFS is defined as local prostate cancer recurrence, distant metastatic prostate cancer recurrence, biochemical recurrence of PSA, or death from any cause
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 anticancer therapy.
- Has a life expectancy \>5 years. Additional key eligibility criteria immediately postoperative for inclusion in the randomized population include:
- 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.
Where
- Chicago, Illinois
- Gahanna, Ohio
- Myrtle Beach, South Carolina
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 21, 2024 · Source of record for eligibility and locations