Epigenetic therapy given before prostatectomy for men with prostate cancer
IIT2023-10-Posadas-PC-Net : A Platform Study of Epigenetic Therapy Before Prostatectomy in Men With Prostate Cancer
This will try short courses of epigenetic drugs before prostatectomy to see if they make tumors more sensitive to the immune system in men with high-risk localized prostate cancer.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Cedars-Sinai Medical Center Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT06888102 on ClinicalTrials.gov |
What this trial studies
This open-label, non-randomized platform protocol gives men undergoing radical prostatectomy short-course epigenetic therapy prior to surgery. Participants are assigned to specific intervention cohorts that typically deliver agents for up to about four weeks at doses known to be clinically safe, with exact regimens defined in cohort appendices. The study focuses on safety monitoring, biomarker characterization from preoperative biopsies and surgical specimens, and early signs of antitumor activity. The platform design allows adding or modifying therapy modules as new data emerge.
Who should consider this trial
Good fit: Men aged 18 or older with high-risk localized prostate cancer who are planning radical prostatectomy, have ECOG 0–1, adequate organ function, and agree to provide preoperative biopsy and surgical tissue are the intended candidates.
Not a fit: Patients with metastatic disease, poor organ function, ECOG performance status ≥2, or those not proceeding to prostatectomy are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the approach could increase immune recognition of prostate tumors and potentially improve surgical outcomes or lower the risk of recurrence.
How similar studies have performed: Epigenetic agents have shown promising biomarker changes and occasional clinical benefit in other cancers, but using them as a neoadjuvant approach in localized prostate cancer remains experimental with limited prior success.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Los Angeles, California
- Cedars-Sinai Cancer at SOCC — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Edwin Posadas, MD — Cedars-Sinai Medical Center
- Study coordinator: Clinical Trial Navigator
- Email: cancer.trial.info@cshs.org
- Phone: 3104232133
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.