MedTrace Logo

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

NCT06636682 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-10-21

No results posted yet for this 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

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

Sponsors & Collaborators

  • Cellvax Therapeutics Inc

    lead INDUSTRY

Principal Investigators

  • Fernando Kreutz, MD PhD · Cellvax Therapeutics Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-14
Primary Completion
2027-02-02
Completion
2027-05-04
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06636682 on ClinicalTrials.gov