Actively Recruiting
A Multicenter, Adaptive, Phase 2, Randomized, Open-label Study of Irradiated Autologous Cellular Vaccine in Men With High-Risk Prostate Cancer Following Prostatectomy
Led by Cellvax Therapeutics Inc · Updated on 2024-10-21
100
Participants Needed
3
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the vaccine FK-PC101 to see if it can delay or prevent the return of prostate cancer in men who have had surgery to remove their prostate tumor. This Phase 2, randomized, open-label trial compares FK-PC101 to current treatment practices in men with localized high-risk prostate cancer. The study also aims to learn about the safety of FK-PC101 and how it affects participants medically. In this study, men will have a sample of their prostate cancer tissue collected during surgery to create a personalized vaccine. Those randomized to the vaccine group will receive up to 7 doses of FK-PC101 over a 6-month period, starting 2 months after surgery. The vaccine doses are given intradermally and include the immune adjuvant BCG for the first two doses. Men in the control group will receive standard care without adjuvant therapy but may receive the vaccine if their cancer returns within a year after surgery. Participants will attend multiple clinic visits for treatment or follow-up over approximately 22 months. Regular blood tests and scans will monitor if the cancer returns. Researchers will assess disease-free survival as the primary outcome, along with time to next treatment, metastasis-free survival, immune response to FK-PC101, and safety. The study involves careful screening before surgery, post-surgery eligibility checks, and ongoing evaluations throughout the study period.
CONDITIONS
Brief 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
- PSA level greater than 4 ng/mL measured within 28 days before enrollment
- No evidence of distant metastases based on PSMA-PET/CT within 28 days before enrollment
- Scheduled for radical prostatectomy 3 to 14 days after enrollment
- Has not received or plans to receive preoperative radiation, androgen deprivation therapy, or other anticancer therapies
- Life expectancy greater than 5 years
- Postoperative tumor stage greater than pT3a
- Gleason score of 8, 9, or 10 on prostatectomy specimen, or pT3b or pT4 tumors with Gleason sum 7 (4+3)
- Pelvic lymph node dissection performed with pN0 or pN1 nodal status
- Negative or microscopic-only positive surgical margins
- FK-PC101 vaccine produced and meeting release specifications
- Undetectable PSA (<0.04 ng/mL) before randomization
- No prior, current, or planned postoperative or adjuvant radiation, hormonal, or anticancer therapy until recurrence evidence
- Adequate organ function based on recent blood tests
- 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
- Eligible for and chooses to receive adjuvant therapy after prostatectomy
- Clinically significant cardiovascular disease or recent serious heart events
- Uncontrolled significant pulmonary disease
- Known bone, visceral, brain, or leptomeningeal metastases
- Active autoimmune disease or severe pneumonitis requiring systemic treatment in past 2 years
- Receiving systemic steroid therapy above prednisone 10 mg daily or other immunosuppressives recently
- Uncontrolled infection, blood clotting disorders, psychiatric illness, or social issues limiting compliance
- At risk for disseminated BCG infection or allergy to BCG or its components
- Known positive HIV or active/chronic Hepatitis B or C
- Any medical condition posing high risk for toxicity as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 14 days before radical prostatectomy
Participants are screened for eligibility to participate in the trial.
3-step screening and enrollment process
Duration - Up to 6 months post-prostatectomy
Participants randomized to the vaccine group receive up to 7 doses of FK-PC101 vaccine administered intradermally between Day 1 and Day 180 after prostatectomy. The control group receives standard-of-care without adjuvant therapy.
7 vaccine dosing visits on Days 1, 8, 15, 22, 60, 90, and 180; control group observed without vaccine visits
Duration - Up to 22 months post-randomization
Participants continue with follow-up visits to monitor disease status and safety up to 22 months after randomization.
Follow-up visits at 2, 3, 6, 10, 14, 18, and 22 months post-randomization
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
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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