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FK-PC101 for Prostate Cancer

Phase 2
Recruiting
Research Sponsored by Cellvax Therapeutics Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Must not have
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 angina, pulmonary embolism or stroke within 6 months prior to study entry, uncontrolled hypertension, or clinically significant arrhythmias not controlled by medication)
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 requirements
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline until month 22
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to determine if the vaccine FK-PC101 can delay or prevent the return of prostate cancer in men who have undergone surgery to remove their prostate cancer. Researchers will compare FK-PC101

Who is the study for?
Men with high-risk prostate cancer who've had surgery to remove their tumor can join. They must be healthy enough for regular visits, blood tests, and scans over nearly 2 years. Those with certain medical conditions or treatments that could interfere are excluded.
What is being tested?
The trial is testing FK-PC101, a personalized vaccine made from the patient's own cancer tissue, against standard care. It aims to see if this vaccine can delay or prevent cancer return post-surgery. Participants will either receive the vaccine up to 7 times in 6 months or follow current treatment practices.
What are the potential side effects?
While specific side effects of FK-PC101 aren't listed here, vaccines like this may cause reactions at the injection site, flu-like symptoms, fatigue, and possibly allergic responses. Regular monitoring will assess safety.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My prostate cancer is classified as high-risk or very high-risk.
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My prostate biopsy shows more than half of at least 3 samples are cancerous.
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My prostate cancer has spread outside the prostate on one side.
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My prostate cancer is advanced with a Gleason score of 7 (4+3).
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I have had surgery to remove lymph nodes in my pelvis.
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I am scheduled for a major prostate surgery within 3 to 14 days after joining.
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I haven't had, nor plan to have, radiation or hormone therapy for prostate cancer unless it comes back.
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My recent blood tests show my organs are functioning well.
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My prostate cancer is aggressive with a Gleason score of 8-10.
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My surgery removed all visible cancer, or only tiny amounts were left.
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I haven't had, nor plan to have, pre-surgery radiation, hormone therapy, or other cancer treatments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have serious heart problems or recent major heart events.
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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.
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My cancer has spread to my bones, organs, or brain.
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I haven't needed strong medication for autoimmune disease or severe lung inflammation in the last 2 years.
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I am on steroids or other immunosuppressants.
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I am HIV positive or have active/chronic Hepatitis B or C.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline until month 22
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline until month 22 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Disease-free survival (DFS)
Secondary study objectives
Immune response to FK-PC101
Metastasis-free survival (MFS)
Safety and tolerability of FK-PC101
+1 more
Other study objectives
Overall survival (OS)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: FK-PC101Experimental Treatment1 Intervention
Up to 7 doses of intradermal FK-PC101 vaccine
Group II: Standard of CareActive Control1 Intervention
Standard of care, with possibility to cross-over to FK-PC101 vaccine should prostate cancer recur within 1 year of radical prostatectomy

Find a Location

Who is running the clinical trial?

Cellvax Therapeutics IncLead Sponsor
Fernando Kreutz, MD PhDStudy ChairCellvax Therapeutics Inc
~67 spots leftby Feb 2027
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