A Platform Study of Epigenetic Therapy Before Prostatectomy in Men With Prostate Cancer

Part of paid clinical trials in Los Angeles, California.

Sponsor
Edwin Posadas, MD
Study ID
NCT06888102
Phase
EARLY_PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • High-risk Prostate Cancer

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Neoadjuvant Epigenetic Therapy — DRUG
    Participants will be assigned to receive one of the study interventions and will be monitored for safety and response. The duration of epigenetic therapy will be dependent on the treatment administered and will continue for the duration described in the cohort appendix for each respective combination, unless the participant: is no longer clinically benefiting (NLCB, as evidenced by symptomatic or radiographic disease progression and/or clinical deterioration); experiences any toxicity meeting specified discontinuation criteria (as described in the cohort appendix for each respective combination) or unacceptable toxicity in the best clinical discretion of the treating physician (i.e., Investigator discretion); reaches the maximum duration of study intervention; or withdraws consent.

Study Details

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.

Key Dates

Start date
Apr 30, 2026
Status verified
Feb 2026
Primary completion
Oct 31, 2028
Completion
Oct 31, 2029

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Neoadjuvant Epigenetic Therapy

Primary Outcome Measure

Safety of Using Epigentic Therapy [ Time Frame: 2 Years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Cancer at SOCCLos AngelesCalifornia90048
Clinical Trial Recruitment Navigator
Edwin Posadas, MD (PRINCIPAL_INVESTIGATOR)
Hyung L Kim, MD (SUB_INVESTIGATOR)
Stephen Freedland, MD (SUB_INVESTIGATOR)
Michael Ahdoot, MD (SUB_INVESTIGATOR)
Andrew Hung, MD (SUB_INVESTIGATOR)
Anirban Mitra, MD-PhD (SUB_INVESTIGATOR)
Jun Gong, MD (SUB_INVESTIGATOR)
Nikka Berkowitz, NP (SUB_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By research site
Cedars-Sinai Cancer at SOCC· Los Angeles, CA

Related Studies