Actively Recruiting
FK-PC101 as Adjuvant Therapy for Men With High-Risk Prostate Cancer
Led by Cellvax Therapeutics Inc · Updated on 2024-10-21
100
Participants Needed
3
Research Sites
133 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
FK-PC101 as Adjuvant Therapy for Men With High-Risk Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Has localized high-risk or very high-risk prostate cancer based on NCCN v4.2023 classification
- Has 3 or more prostate biopsy cores with 50% or more tumor involvement
- Has PSA greater than 4 ng/mL within 28 days before enrollment
- Has no distant metastases based on PSMA-PET/CT within 28 days before enrollment
- Is a candidate for radical prostatectomy scheduled 3 to 14 days after enrollment
- Has not received and does not plan to receive neoadjuvant radiation, androgen deprivation therapy, or other anticancer therapy
- Has a life expectancy greater than 5 years
- After surgery, has tumor stage greater than pT3a
- Has Gleason score 8, 9, or 10 on prostatectomy specimen
- Subjects with pT3b or pT4 tumors with Gleason sum 7 (4+3) are eligible
- Underwent pelvic lymph node dissection with pN0 or pN1 nodal staging
- Has negative or microscopic-only positive surgical margins
- FK-PC101 vaccine has been produced and meets release standards
- Has undetectable PSA (<0.04 ng/mL) before randomization
- Has not received and will not receive postoperative radiation, hormonal therapy, or other anticancer therapy before evidence of recurrence
- Has adequate organ function based on blood tests within 2 weeks before dosing
- Is able to give informed consent and comply with study requirements
You will not qualify if you...
- Has an additional active malignancy that could affect study results, except certain skin cancers and carcinomas in situ
- Is eligible for or chooses to receive adjuvant therapy after surgery
- Has significant cardiovascular disease or recent heart problems
- Has uncontrolled serious lung disease
- Has known metastases including bone, visceral, brain, or leptomeningeal
- Has active autoimmune disease or severe pneumonitis needing systemic treatment in past 2 years
- Is receiving high-dose steroids or immunosuppressive therapy
- Has uncontrolled infection, blood clotting disorder, or psychiatric/social issues that limit compliance
- Is at risk for disseminated BCG infection or allergic to BCG or its components
- Has known HIV infection or active/chronic Hepatitis B or C
- Has any medical condition that puts them at high risk for toxicity as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 3 locations
1
University of Chicago Medicine, High-Risk and Advanced Prostate Cancer Clinic
Chicago, Illinois, United States, 60637
Active, Not Recruiting
2
Central Ohio Urology Group
Gahanna, Ohio, United States, 43230
Actively Recruiting
3
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
Actively Recruiting
Research Team
F
FK-PC101 Trial Management
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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