FK-PC101 as Adjuvant Therapy for Men With High-Risk Prostate Cancer

Conditions

• High-risk Prostate Cancer
• Prostate CA
• Prostate Cancer
• Prostate Cancer (Adenocarcinoma)
• Prostate Cancer (Post Prostatectomy)
• Prostate Cancer Patients Undergoing Radical Prostatectomy
• Prostate Cancers

Eligibility Criteria

Sex

MALE

Age

N/A - N/A

Healthy Volunteers

Not accepted

Interventions

• FK-PC101 — BIOLOGICAL
  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).
• Standard of Care (SOC) — BIOLOGICAL
  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).

Study Details

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.

Key Dates

Start date

Oct 14, 2024

Status verified

Oct 2024

Primary completion

Feb 2, 2027

Completion

May 4, 2027

Study Design

Enrollment

100 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• Experimental: FK-PC101
  Up to 7 doses of intradermal FK-PC101 vaccine
• Active Comparator: Standard of Care
  Standard of care, with possibility to cross-over to FK-PC101 vaccine should prostate cancer recur within 1 year of radical prostatectomy

Primary Outcome Measure

Disease-free survival (DFS) [ Time Frame: Up to approximately 22 months ]

Central Contacts

• FK-PC101 Trial Management
  215-941-5916
  [email protected]

Locations (3)

Find similar trials in Chicago, IL

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