RecruitingEarly Phase 1NCT06888102

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

IIT2023-10-Posadas-PC-Net : A Platform Study of Epigenetic Therapy Before Prostatectomy in Men With Prostate Cancer

Sponsor

Edwin Posadas, MD

Enrollment

20 participants

Start Date

Apr 1, 2026

Study Type

INTERVENTIONAL

Conditions

High-risk Prostate Cancer

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 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.

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests experimental epigenetic therapies — drugs that change how genes are switched on or off in cancer cells — given before prostate removal surgery. The goal is to see if these drugs shrink the tumor or change it in ways that could improve long-term outcomes. **You may be eligible if...** - You are a man aged 18 or older with prostate cancer - You have decided to have your prostate surgically removed - You are in good physical condition (ECOG performance score 0 or 1) - Your blood counts, liver, and kidneys are working adequately - You are willing to use contraception if your partner could become pregnant **You may NOT be eligible if...** - You have already received chemotherapy or radiation for prostate cancer - Your organ function tests are outside acceptable ranges - You have uncontrolled medical conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNeoadjuvant Epigenetic Therapy

Participants will be assigned to receive one of the study interventions and will be monitored for safety and response. The duration of epigenetic therapy will be dependent on the treatment administered and will continue for the duration described in the cohort appendix for each respective combination, unless the participant: is no longer clinically benefiting (NLCB, as evidenced by symptomatic or radiographic disease progression and/or clinical deterioration); experiences any toxicity meeting specified discontinuation criteria (as described in the cohort appendix for each respective combination) or unacceptable toxicity in the best clinical discretion of the treating physician (i.e., Investigator discretion); reaches the maximum duration of study intervention; or withdraws consent.