NCT06888102RecruitingEarly phase 1
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
Source: ClinicalTrials.gov · Last updated 3 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 11 Oct 2024
- Start date
- Apr 2026
- Primary completion date
- Oct 2028
- Lead sponsor
- Edwin Posadas, MD
- Diseases
- Prostate cancer
- NCT number
- NCT06888102
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 20
- From Apr 2026 to the primary completion date, Oct 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently participating in a study using an investigational, medicinal anti-cancer agent within 4 weeks prior to first dose of epigenetic therapy.
Other illness
- 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)
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cedars-Sinai Cancer at SOCC Coordinator of this site? Confirm its status | Los Angeles | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.