Recruiting
Early Phase 1

Epigenetic Therapy

Sponsor:

Edwin Posadas, MD

Code:

NCT06888102

Conditions

High-risk Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Neoadjuvant Epigenetic Therapy

Study Details

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 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.

Conditions

High-risk Prostate Cancer

Study ID

NCT06888102

Start date

Apr, 2026

Status verified date

Feb, 2026

Completion date

Oct, 2029

Anticipated

Primary completion date

Oct, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Neoadjuvant Epigenetic Therapy

Interventions

Neoadjuvant 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.

Primary outcome measure

  • Safety of Using Epigentic Therapy [ Time Frame: 2 Years ]
  • Toxicity of Using Epigentic Therapy [ Time Frame: 2 Years ]
  • Feasibility - % of Patients Able to Undergo Surgery [ Time Frame: 2 Years ]
  • Feasibility - % of patients with grade 3/4 AEs related [ Time Frame: 2 Years ]
  • Feasibility - % of patients with evaluable tissue specimens [ Time Frame: 2 Years ]

Central Contacts and Locations

Central contacts

Clinical Trial Navigator

3104232133cancer.trial.info@cshs.org

Locations

Cedars-Sinai Cancer at SOCC

Recruiting

Los Angeles, California, United States, 90048

Principal Investigator:

Edwin Posadas, MD

More Information

Sponsor

Edwin Posadas, MD

Last update posted

Feb 3, 2026

Last verified

Feb, 2026

Keywords

  • Epigenetic Therapy
  • PD-L1
  • radical prostatectomy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Edwin Posadas, MD on 2026-02-03.