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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests the safety and cancer-fighting effects of epigenetic drugs, which affect how genes work. These drugs aim to help the body's immune system attack the cancer. It is for men with prostate cancer that has not spread who plan to have surgery to remove the prostate.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You are a man age 18 or older.
- You plan to have surgery to remove the whole prostate, and a tissue sample is available before surgery.
- You can do all usual activities, or you have trouble only with hard physical activity.
- Your blood tests meet the study's limits for liver and kidney function, red blood cells, and platelets (cells that help blood clot).
- If you could get a partner pregnant, you must have a vasectomy confirmed to leave no live sperm, avoid sex completely, or use latex or synthetic condoms during sex. Follow these rules from the start of treatment until 3 months after the last dose.
- You must not donate sperm during treatment, during treatment breaks, or for 3 months after treatment ends.
- You can follow the study rules and sign a form agreeing to take part.
Who can't join
- You have another active illness or cancer that needs treatment besides prostate cancer.
- You are receiving other cancer treatment, such as chemotherapy, hormone treatment, radiation, surgery, or treatment that uses the immune system.
- You are taking part in a study using an experimental cancer drug within 4 weeks before your first dose of the study treatment.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility 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.
Study sites (1)
CA
- Cedars-Sinai Cancer at SOCC · Los Angeles, CA 90048Clinical Trial Recruitment Navigator · Study contactEdwin Posadas, MD · Principal investigatorHyung L Kim, MD · Sub-investigatorStephen Freedland, MD · Sub-investigatorMore trials in Los Angeles