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NCT02772588PHASE2COMPLETED

AASUR in High Risk Prostate Cancer

ARN-509+Abiraterone Acetate+Leuprolide With Stereotactic, Ultra-Hypofractionated Radiation (AASUR) in Very High Risk Prostate Cancer: A Single Arm, Phase II Study

Sponsor: Memorial Sloan Kettering Cancer Center + Janssen Pharmaceuticals, Weill Medical College of Cornell University

No open prediction endpoints

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Key Facts

Study type
INTERVENTIONAL
Conditions
Prostate Cancer
Interventions
ARN-509, Abiraterone, Leuprolide, stereotactic, ultra-fractionated radiotherapy
Enrollment
64 participants
Primary completion
Jan 2026
Study completion
Jan 2026
First posted
May 2016
Last updated
Apr 2026

Primary Endpoints (CT.gov)

Number of Participants With Biochemical Failure

Time frame: 36 months

Eligibility Criteria

Inclusion Criteria: * Histological or cytologic evidence of adenocarcinoma of the prostate confirmed at local institution. * At least one of the following: * Two or more high risk features OR * Gleason score 8-10 * PSA ≥20 ng/mL within two months prior to registration * Clinical Stage ≥T3 disease, as determined by standard digital rectal examination (DRE) * Radiographic stage ≥T3 disease as determined by a ≥75% probability of extracapsular extension or seminal vesicle invasion per reading radiologist * Any Gleason 9 or 10 disease OR \>4 cores of Gleason 8 disease * KPS ≥ 70% * IPSS (International Prostate Symptom Score) ≤ 20F * Patient must be available for follow-up * Laboratory test findings within 28 days of study registration : * Adequate hepatic function: * Bilirubin ≤ 1.5 times the upper institutional limits of normal (ULN). Patients with a history of Gilbert's syndrome may be enrolled if the total bilirubin is \< 3 mg/dL with a predominance of indirect bilirubin. If the total b

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✦ Analyst Commentary

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

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Source

Open on ClinicalTrials.gov