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Can epigenetic drugs prime prostate tumors for immune attack before surgery?

NCT ID NCT06888102

Disease control Sponsor: Edwin Posadas, MD Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This early-phase trial is testing whether giving epigenetic therapy before prostate removal can make the cancer more visible to the immune system. About 20 men with high-risk prostate cancer will receive the drugs before their scheduled prostatectomy. The main goals are to check safety, see if the treatment delays surgery, and measure changes in gene activity in the removed tissue.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
epigenetic therapy (drugs that change gene activity to help the immune system attack cancer)
What this could lead to
If it works, this could point toward a new way to make prostate cancer more sensitive to the immune system before surgery.
What could go wrong
This is a very early, small trial (20 men) focused on safety and feasibility, not effectiveness. The drugs may cause side effects or not improve outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Oct 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

prostate cancer prostate carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

High-risk prostate cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cedars-Sinai Cancer at SOCC

    RECRUITING

    Los Angeles, California, 90048, United States

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