A Platform Study of Epigenetic Therapy Before Prostatectomy in Men With Prostate Cancer
Recruiting
Early Phase 1
Interventional Study
High-risk Prostate Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Male
- Trial phase
- Early Phase 1
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 20 (estimated)
- Sponsor
- Edwin Posadas, MD · Other
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About This Trial
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, bioma…
Trial Locations
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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
…
Contacts