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.
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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 …
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