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NCT03436654PHASE2ACTIVE_NOT_RECRUITING

Multi-arm Multi-modality Therapy for Very High Risk Localized and Low Volume Metastatic Prostatic Adenocarcinoma

Sponsor: Memorial Sloan Kettering Cancer Center + Dana-Farber Cancer Institute

No open prediction endpoints

Endpoints are classified and published by ProgramSignal analysts.

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Key Facts

Study type
INTERVENTIONAL
Conditions
Prostate Cancer
Interventions
Apalutamide, Abiraterone Acetate, Prednisone, GnRH agonist/antagonist
Enrollment
102 participants
Primary completion
Mar 2026
Study completion
Feb 2027
First posted
Feb 2018
Last updated
Apr 2026

Primary Endpoints (CT.gov)

Pathologic Response (pCR + MRD) in the RP specimen

Time frame: 6 months

Secondary Endpoints

Rate of undetectable PSA level following Testosterone recovery at 24 months from the time of randomization

Time to and frequency of testosterone recovery

Eligibility Criteria

Inclusion Criteria: * Willing and able to provide written informed consent and Authorization for Use and Release of Health and Research Study Information (HIPAA authorization) NOTE: HIPAA authorization may be either included in the informed consent or obtained separately * Male aged 18 years and above * Serum testosterone of ≥150 ng/dL (For Cohorts A and B1, testosterone level requirement is exempted if they are already on ADT prior to treatment start. For Cohort B2, subjects will be considered eligible if their testosterone is currently ≥150 ng/dl). * Histologically confirmed adenocarcinoma of the prostate, who meet the following criteria: Cohort A * Clinically localized disease with histologically confirmed adenocarcinoma of the prostate with either ≥3 positive cores or 2 positive cores if \>1cm in length with at least 50% tumor content WITH * With Gleason score 8-10 OR * Gleason 4+3 with one of the following features: * PSA ≥ 20 mg/mL within 2 months prior to diagnostic biopsy

Read full criteria on CT.gov →

✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

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Source

Open on ClinicalTrials.gov