Actively Recruiting
A Platform Study of Epigenetic Therapy Before Prostatectomy in Men With Prostate Cancer
Led by Edwin Posadas, MD · Updated on 2026-02-03
20
Participants Needed
1
Research Sites
182 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open-label, non-randomized, exploratory platform protocol designed to assess the safety and antitumor activity of epigenetic therapies in participants with localized prostate cancer who are undergoing radical prostatectomy. The epigenetic therapy is intended to increase the sensitivity of the underlying tumor to the patient's immune system. The platform study will evaluate safety, biomarkers, and clinical activity of an epigenetic therapy. The particular details relevant to each module within this platform study will be provided as appendices to the core protocol.
CONDITIONS
Official Title
A Platform Study of Epigenetic Therapy Before Prostatectomy in Men With Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male patients electing to undergo radical prostatectomy with preoperative tissue available
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ function defined by: AST and ALT less than 2.5 times the upper limit of normal (ULN)
- Total bilirubin less than 1.5 times ULN
- Platelet count greater than 90,000 per microliter
- Hemoglobin greater than 8.5 g/dL
- Serum creatinine less than 1.5 times ULN or estimated glomerular filtration rate (eGFR) greater than 30 mL/min
- If sexually active with partners of childbearing potential, must have had successful vasectomy or agree to use adequate contraception from the start of treatment until 3 months after last dose
- Written informed consent and ability to comply with study requirements
You will not qualify if you...
- Active illness or cancer other than prostate cancer requiring therapy
- Previous anti-cancer therapy including chemotherapy, hormonal therapy, radiation, surgery, immunotherapy, biologic therapy, or tumor embolization
- Participation in another investigational anti-cancer agent study within 4 weeks prior to starting epigenetic therapy
AI-Screening
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Trial Site Locations
Total: 1 location
1
Cedars-Sinai Cancer at SOCC
Los Angeles, California, United States, 90048
Actively Recruiting
Research Team
C
Clinical Trial Navigator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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