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New treatment option for High-risk Prostate Cancer
Official title A Platform Study of Epigenetic Therapy Before Prostatectomy in Men With Prostate Cancer
ClinicalTrials.gov ID: NCT06888102
What this study is testing
What is Neoadjuvant Epigenetic Therapy?
Neoadjuvant Epigenetic Therapy is an investigational medicine, being studied as a potential treatment for high-risk prostate cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, men only
You may be able to join if
- 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
You likely can't join if
- 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.
See the full eligibility 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) \ 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...
- Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.