Epigenetic therapy given before prostatectomy for men with prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, non-randomized platform protocol gives men undergoing radical prostatectomy short-course epigenetic therapy prior to surgery. Participants are assigned to specific intervention cohorts that typically deliver agents for up to about four weeks at doses known to be clinically safe, with exact regimens defined in cohort appendices. The study focuses on safety monitoring, biomarker characterization from preoperative biopsies and surgical specimens, and early signs of antitumor activity. The platform design allows adding or modifying therapy modules as new data emerge.

Why it matters

Who can join: the full rules

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.

Where it's running

• Cedars-Sinai Cancer at SOCC
  Los Angeles, California, United States Recruiting

Study contacts

• Principal investigator: Edwin Posadas, MD — Cedars-Sinai Medical Center
• Study coordinator: Clinical Trial Navigator
• Email: cancer.trial.info@cshs.org
• Phone: 3104232133

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.