A Platform Study of Epigenetic Therapy Before Prostatectomy in Men With Prostate Cancer
ConditionHigh-risk Prostate Cancer
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexMale
Age18+
SponsorEdwin Posadas, MD
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, 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.
Eligibility criteria
Qualifiers
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
AST and ALT < 2.5 x ULN
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Neoadjuvant Epigenetic Therapy
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Edwin Posadas, MD
Lead sponsor
Cedars-Sinai Medical Center
Sponsor institution
Source ClinicalTrials.gov