Androgen Receptor Antagonist ARN-509 With or Without Abiraterone Acetate, Gonadotropin-Releasing Hormone Analog, and Prednisone in Treating Patients With High-Risk Prostate Cancer Undergoing Surgery
Randomized Three-Arm Trial to Evaluate the Effect of Neoadjuvant Apalutamide Alone or in Combination With Abiraterone Acetate and GnRH Agonist on Enhancing Surgical Outcome of Nerve-Sparing Radical Prostatectomy in Men With High-Risk Prostate Cancer
Sponsor: Rutgers, The State University of New Jersey + National Cancer Institute (NCI)
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
Request endpoint coverageKey Facts
Primary Endpoints (CT.gov)
Post-surgical potency rate defined as proportion of patients with International Index of Erectile Function score >= 17
Time frame: At 12 months
Secondary Endpoints
Change in tumor volume on pelvic MRI after neoadjuvant therapy
Number of patients with biochemical recurrence defined using the Prostate Cancer Clinical Trials Working Group 2 definition
Number of patients with pathological T0
Eligibility Criteria
Inclusion Criteria: * Histologically proven adenocarcinoma of the prostate and: Gleason \> 8 OR prostatic specific antigen (PSA) \> 20 and more than 1 positive core * Patients with Eastern Cooperative Oncology Group performance scale (ECOG PS) 0 or 1 * Clinical stage T3 or less as demonstrated by abdominal/pelvic computed tomography (CT) or magnetic resonance imaging (MRI) will be selected as the prostate is resectable * Hemoglobin \>= 9.0 g/dL, independent of transfusion and/or growth factors within 3 months prior to randomization * Platelet count \>= 100,000 x 10\^9/uL independent of transfusion and/or growth factors within 3 months prior to randomization * Serum albumin \>= 3.0 g/dL * Glomerular filtration rate (GFR) \>= 45 mL/min * Serum potassium \>= 3.5 mmol/L * Serum total bilirubin =\< 1.5 × upper limit of normal (ULN) (Note: In subjects with Gilbert's syndrome, if total bilirubin is \> 1.5 × ULN, measure direct and indirect bilirubin and if direct bilirubin is =\< 1.5 × ULN, …
Read full criteria on CT.gov →✦ Analyst Commentary
Expert commentary on why this trial matters and what to watch for.
Request coverage →