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NCT06636682 · ClinicalTrials.gov registry record · Phase 2
FK-PC101 as Adjuvant Therapy for Men With High-Risk Prostate Cancer
A Phase 2 study of Prostate Cancer and Prostate Cancer (Adenocarcinoma), sponsored by Cellvax Therapeutics.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
- 3
- Study locations
NCT06636682 is a Phase 2 study of Prostate Cancer and Prostate Cancer (Adenocarcinoma) that is actively recruiting participants, run by Cellvax Therapeutics. The registered enrollment target is 100 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (84% lower). The trial reports 3 study locations across 3 states.
The verdict
NCT06636682, a Phase 2 study of Prostate Cancer and Prostate Cancer (Adenocarcinoma), is actively recruiting participants, sponsored by Cellvax Therapeutics.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
- 3
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 2. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (84% lower). The listed sponsor is Cellvax Therapeutics, which has 1 total studies on file at ClinicalTrials.gov.
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.
NCT06636682 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Illinois, Ohio, South Carolina.
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), High-risk Prostate Cancer, Prostate CA, Prostate Cancers.
What interventions are being tested in trial NCT06636682?
The interventions under investigation include: FK-PC101 (BIOLOGICAL), Standard of Care (SOC) (BIOLOGICAL).
Who is sponsoring clinical trial NCT06636682?
This trial is sponsored by Cellvax Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov.
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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