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New treatment option for Prostate Cancer (Adenocarcinoma)
Official title FK-PC101 as Adjuvant Therapy for Men With High-Risk Prostate Cancer
ClinicalTrials.gov ID: NCT06636682
What this study is testing
What is FK-PC101?
FK-PC101 is an investigational medicine, being studied as a potential treatment for prostate cancer (adenocarcinoma).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 22 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults, men only
You may be able to join if
- 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.
- Is a candidate for radical prostatectomy, and scheduled radical prostatectomy date must be 3 to 14 days after enrollment.
You likely can't join if
- Has an additional active malignancy that may confound the assessment of the study endpoints. If the subject has a past cancer history (active...
- Is eligible for and elects to receive adjuvant therapy following RP.
- Has clinically significant cardiovascular disease (e.g., uncontrolled or any New York Heart Association [NYHA] Class 3 or 4 congestive heart failure...
- Has uncontrolled, clinically significant pulmonary disease (e.g., chronic obstructive pulmonary disease, pulmonary hypertension) that in the opinion...
- Has known metastases, such as bone, visceral, or brain or leptomeningeal metastases.
- Has an active autoimmune disease or Grade ≥3 pneumonitis that has required systemic treatment in the past 2 years (i.e., with use of...
See the full 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.
- Is a candidate for radical prostatectomy, and scheduled radical prostatectomy date must be 3 to 14 days after enrollment.
- Has not received nor plans to receive neoadjuvant (preoperative) radiation therapy, androgen deprivation therapy (ADT), or any other anticancer therapy.
- Has a life expectancy \>5 years. Additional key eligibility criteria immediately postoperative for inclusion in the assigned by chance population include:
- Stage \>pT3a (tumor has extended outside of the prostate on one side).
- Gleason score of 8, 9, or 10 (high/very high) on prostatectomy specimen.
- people with pT3b or pT4 tumors with a Gleason sum 7 (4+3) are eligible.
- Pelvic lymph node dissection (PLND) is required with either pN0 or pN1 nodal staging permitted.
- people must have negative surgical margins or microscopic-only positive surgical margins. Final eligibility criteria at 2 months postoperative for randomization include:
- FK-PC101 has been produced for the subject and meets all release specifications.
- An undetectable PSA (\<0.04 ng/mL) on the most recent test performed prior to randomization (Day -4 to -7).
- No prior, current, or planned future postoperative or adjuvant XRT, hormonal therapy such as ADT, or any other anticancer therapy (future therapy should not be administered until evidence exists of prostate cancer...
- Adequate organ function based on CBC and chemistry studies within 2 weeks of Day 1 (Day -14 to -7). Specific laboratory requirements include:
- Absolute neutrophil count (ANC) \>1000/µL
- Platelet count \>100,000/µL.
- Hemoglobin \>8.0 gm/dL.
- Estimated glomerular filtration rate (eGFR) \>60 mL/minute based on Cockcroft-Gault formula.
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) both \<2 × upper limit of normal (ULN).
- Albumin \>3.0 gm/dL.
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions of the study.
- Has an additional active malignancy that may confound the assessment of the study endpoints. If the subject has a past cancer history (active malignancy within 2 years prior to study entry) with substantial potential...
- Is eligible for and elects to receive adjuvant therapy following RP.
- Has clinically significant cardiovascular disease (e.g., uncontrolled or any New York Heart Association [NYHA] Class 3 or 4 congestive heart failure, uncontrolled angina, history of myocardial infarction, unstable...
- Has uncontrolled, clinically significant pulmonary disease (e.g., chronic obstructive pulmonary disease, pulmonary hypertension) that in the opinion of the Investigator would put the subject at significant risk for...
- Has known metastases, such as bone, visceral, or brain or leptomeningeal metastases.
- Has an active autoimmune disease or Grade ≥3 pneumonitis that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement...
- Is currently receiving systemic steroid therapy at a prednisone equivalent dose of \>10 mg daily for at least 1 week or other form of immunosuppressive therapy within 7 days prior to enrollment.
- Has uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, disseminated intravascular coagulation, or psychiatric illness/social situations that would limit compliance with study...
- Is at risk for disseminated BCG infection or has previously demonstrated an allergic response to BCG or its components.
- Has known positive status for human immunodeficiency virus (HIV) or active or chronic Hepatitis (Hep) B or Hep C. Screening is not required.
- Has any medical condition which in the opinion of the Investigator places the subject at an unacceptably high risk for toxicity.
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
- Gahanna, Ohio, United States
- Myrtle Beach, South Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 22 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling male, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States; Gahanna, Ohio, United States; Myrtle Beach, South Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.