Study on FK-PC101 Vaccine as Additional Treatment for Men with High-Risk Prostate Cancer

Sponsor: Cellvax Therapeutics Inc

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06636682

Provider View

This clinical trial is testing a new vaccine, FK-PC101, to see if it can help delay or prevent prostate cancer from coming back in men who have had surgery to remove their cancer. The study will also look at the safety of the vaccine.

Patient Parameters

Program Overview

The purpose of this study is to find out if the FK-PC101 vaccine can help delay or prevent the return of prostate cancer in men who have had surgery to remove their prostate. The study will also check for any side effects of the vaccine. Participants will be compared to those receiving standard treatment to see if the vaccine is more effective. If chosen to receive the vaccine, participants will get it up to 7 times over 6 months. There will be follow-up visits for nearly 2 years to monitor for any signs of cancer returning. Participants not initially receiving the vaccine can get it if their cancer returns within a year after surgery.

Description

This study involves men with high-risk prostate cancer who have had surgery to remove their prostate. It aims to test the effectiveness of the FK-PC101 vaccine in preventing cancer from coming back. Participants will be randomly assigned to either receive the vaccine or follow standard treatment. Those receiving the vaccine will get up to 7 doses over 6 months, starting 2 months after surgery. All participants will have regular check-ups at 2, 3, 6, 10, 14, 18, and 22 months after starting the study. If cancer returns, participants can receive other treatments as needed. Those in the standard treatment group can receive the vaccine if their cancer comes back within a year. The study will monitor the safety and effectiveness of the vaccine in preventing cancer recurrence.

Eligibility Criteria

Inclusion Criteria

  • Have high-risk prostate cancer based on specific medical guidelines.
  • Have a significant amount of cancer in prostate biopsy samples.
  • Have a PSA level greater than 4 ng/mL within 28 days before joining the study.
  • No signs of cancer spread to distant areas based on recent scans.
  • Eligible for prostate surgery, scheduled within 3 to 14 days after joining the study.
  • Have not received or plan to receive pre-surgery radiation or hormone therapy.
  • Expected to live more than 5 years.

Additional criteria after surgery:

  • Cancer has spread outside the prostate on one side.
  • High Gleason score indicating aggressive cancer.
  • Lymph node surgery required, with specific staging allowed.
  • Negative or minimal positive surgical margins.

Final criteria 2 months after surgery:

  • Vaccine has been prepared and meets quality standards.
  • PSA level is undetectable on recent tests.
  • No plans for additional cancer treatments unless cancer returns.
  • Good organ function based on recent blood tests.
  • Able to give informed consent and follow study requirements.

Exclusion Criteria

  • Have another active cancer that could affect study results.
  • Eligible for and choose to receive additional therapy after surgery.
  • Have significant heart disease or recent heart problems.
  • Have uncontrolled lung disease that could increase risk during the study.
  • Have known cancer spread to bones, organs, or brain.
  • Have an active autoimmune disease or severe lung inflammation treated in the past 2 years.
  • Currently taking high-dose steroids or other immune-suppressing drugs.
  • Have uncontrolled illness or psychiatric conditions affecting study participation.
  • At risk for certain infections or allergic to specific components of the vaccine.
  • Have known HIV or active hepatitis B or C infections.
  • Have any medical condition that poses a high risk for treatment side effects.

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