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 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

Trial Details

NCT ID

NCT06636682

Phase

PHASE2

Sponsor

Cellvax Therapeutics Inc

Status

RECRUITING

Cancer Type

Prostate Cancer

Interventions

FK-PC101
Standard of Care (SOC)

Locations (sample)

Chicago, Illinois, United States|41.85003,-87.65005
Gahanna, Ohio, United States|40.01923,-82.87934
Myrtle Beach, South Carolina, United States|33.68906,-78.88669

Key Eligibility 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.

For full eligibility, visit ClinicalTrials.gov.

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