Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
FK-PC101 as Adjuvant Therapy for Men With High-Risk Prostate Cancer
NCT06636682 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- BIOLOGICAL FK-PC101
- BIOLOGICAL Standard of Care (SOC)
Study Locations (3)
Illinois
- University of Chicago Medicine, High-Risk and Advanced Prostate Cancer Clinic — Chicago
Ohio
- Central Ohio Urology Group — Gahanna
South Carolina
- Carolina Urologic Research Center — Myrtle Beach
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2024-10-14 |
| Est. Completion | 2027-05-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06636682
The ClinicalTrials.gov registry entry for NCT06636682 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cellvax Therapeutics, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 7 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 2 interventions — of which FK-PC101 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06636682 reports 3 study locations spanning 3 distinct geographic areas — top geographies include Illinois, Ohio, South Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06636682 about?
NCT06636682 is a clinical study titled "FK-PC101 as Adjuvant Therapy for Men With High-Risk Prostate Cancer". 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 ...
What is the current status of trial NCT06636682?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2024-10-14. Estimated completion is 2027-05-04.
What conditions does trial NCT06636682 study?
This clinical trial studies the following conditions: Prostate Cancer, Prostate Cancer (Adenocarcinoma), Prostate CA, High-risk Prostate Cancer, Prostate Cancers. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06636682?
The interventions under investigation include: FK-PC101 (BIOLOGICAL), Standard of Care (SOC) (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06636682?
This trial is sponsored by Cellvax Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06636682 being conducted?
This trial has 3 study locations across Illinois, Ohio, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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