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
Endpoints are classified and published by ProgramSignal analysts.
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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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