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Epigenetic Therapy Before Prostatectomy for High-Risk Prostate Cancer

This study is testing an "Epigenetic Therapy" (a type of treatment that can change how genes work) before surgery (prostatectomy) in men with high-risk prostate cancer. The goal is to see if this therapy is safe and how well it works to make the tumor more sensitive to your body's immune system. Researchers will also look at certain markers (biomarkers) like EGFR and how the immune system responds. You can join if you are a man, 18 or older, planning to have a radical prostatectomy, and meet certain health requirements. The study will measure safety, side effects (toxicity), and if patients can still have surgery, all over 2 years. The current recruitment status is unclear.

Study design
This is an open-label (you and your doctor will know what treatment you are getting), non-randomized study involving about 20 participants.
What's involved
You will receive Epigenetic Therapy for a period that depends on the specific treatment. You will also provide biopsy tissue before surgery and allow the use of surgical specimens for biomarker testing.
Compensation
Not stated in the trial record.
Follow-up
You will be monitored for safety and side effects for up to 2 years after starting treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06888102

A Platform Study of Epigenetic Therapy Before Prostatectomy in Men With Prostate Cancer

Recruiting
EARLY_PHASE1Ages 18+InterventionalTreatment
Edwin Posadas, MD
~20 participants
Updated 2026-02-03 on ClinicalTrials.gov
What's tested:Neoadjuvant Epigenetic Therapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety of Using Epigentic Therapy
Measured over 2 Years
+4 more outcomes measured

Conditions

High-risk Prostate Cancer

Explore related trials

Prostate Carcinoma

Where it's being run

1 sites across 1 states
California1

Study leadership

  • Edwin Posadas, MD · PRINCIPAL_INVESTIGATOR · Cedars-Sinai Medical Center

Who to contact

Clinical Trial Navigator
[email protected]
3104232133
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Safety of Using Epigentic Therapy2 Years

    Safety and tolerability using CTCAE version 5.0. To assess the safety, toxicity, and feasibility of using epigenetic therapy in the neoadjuvant setting for men undergoing radical prostatectomy (RP). Defined by the number of patients who demonstrate treatment related AEs, defined as grade 3 or 4, or grade 2 that causes a dose interruption.

  • Toxicity of Using Epigentic Therapy2 Years

    Safety and tolerability using CTCAE version 5.0. To assess the safety, toxicity, and feasibility of using epigenetic therapy in the neoadjuvant setting for men undergoing radical prostatectomy (RP). Defined by the number of patients that undergo radical prostatectomy without delay due to epigenetic therapy.

  • Feasibility - % of Patients Able to Undergo Surgery2 Years

    Feasibility - Percentage of patients able to undergo surgery. To assess the feasibility of measuring changes in gene expression (in radical prostatectomy \[RP\] tissue) induced by epigenetic therapy at conventional doses (defined by ongoing clinical work focusing on doses within the recommended dose and schedule per the manufacturer where safety has been defined) with a focus on Interferon Stimulated Genes

  • Feasibility - % of patients with grade 3/4 AEs related2 Years

    Feasibility - Percentage of patients with grade 3/4 adverse events related to epigenetic therapy. To assess the feasibility of measuring changes in gene expression (in radical prostatectomy \[RP\] tissue) induced by epigenetic therapy at conventional doses (defined by ongoing clinical work focusing on doses within the recommended dose and schedule per the manufacturer where safety has been defined) with a focus on Interferon Stimulated Genes

  • Feasibility - % of patients with evaluable tissue specimens2 Years

    Feasibility - Percentage of patients with evaluable tissue specimens following epigenetic therapy. To assess the feasibility of measuring changes in gene expression (in radical prostatectomy \[RP\] tissue) induced by epigenetic therapy at conventional doses (defined by ongoing clinical work focusing on doses within the recommended dose and schedule per the manufacturer where safety has been defined) with a focus on Interferon Stimulated Genes. The evaluability of tissue specimens would be defined as the number of subjects that completed epigenetic therapy and underwent RP and undergo any of the correlative studies using tissue or blood.