Status:
RECRUITING
A Platform Study of Epigenetic Therapy Before Prostatectomy in Men With Prostate Cancer
Lead Sponsor:
Edwin Posadas, MD
Conditions:
High-risk Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
EARLY_PHASE1
Brief Summary
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...
Detailed Description
The study lead investigators will modify and/or add new therapies to the protocol as data emerge from this and other trials. Participants must provide consent for archival biopsy tissue prior to surge...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Men electing to undergo radical prostatectomy with preoperative tissue available.
- Age ≥18 years
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
- Adequate organ function defined by:
- AST and ALT \< 2.5 x ULN
- Total bilirubin \< 1.5 x ULN
- Platelets \> 90 x 1000/μL
- Hemoglobin (Hgb) \> 8.5 g/dL
- Serum Creatinine (Cr) \<1.5 x ULN or eGFR \> 30 mL/min
- People with partners of childbearing potential in circumstances that may result in the pregnancy, must have had a successful vasectomy (with medically confirmed lack of sperm that are alive) OR must either practice complete abstinence or agree to use adequate contraception (latex or synthetic condom during sexual contact with a female of childbearing potential) from the start of study treatment until 3 months following last dose of study intervention. Subjects should not donate sperm on study, during interruptions in treatment and for 3 months following completion of study drug treatment.
- Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
- Exclusion Criteria
- Active intercurrent illness or malignancy requiring therapy outside of prostate cancer.
- Other anti-cancer therapy (chemotherapy, hormonal therapy, radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization)
- Currently participating in a study using an investigational, medicinal anti-cancer agent within 4 weeks prior to first dose of epigenetic therapy.
Exclusion
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2029
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06888102
Start Date
December 1 2025
End Date
April 1 2029
Last Update
November 4 2025
Active Locations (1)
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1
Cedars-Sinai Cancer at SOCC
Los Angeles, California, United States, 90048