NCT06636682 - FK-PC101 as Adjuvant Therapy for Men With High-Risk Prostate Cancer | Biotech Hunter

Enrollment

100

Participants

Timeline

Start Date

October 14, 2024

Primary Completion Date

February 2, 2027

Study Completion Date

May 4, 2027

Conditions

Prostate Cancer (Adenocarcinoma)Prostate CAProstate CancersProstate Cancer (Post Prostatectomy)Prostate CancerProstate Cancer Patients Undergoing Radical ProstatectomyHigh-risk Prostate Cancer

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).

Trial Locations (3)

29572

RECRUITING

Carolina Urologic Research Center, Myrtle Beach

43230

RECRUITING

Central Ohio Urology Group, Gahanna

60637

ACTIVE_NOT_RECRUITING

University of Chicago Medicine, High-Risk and Advanced Prostate Cancer Clinic, Chicago