Apalutamide in Treating Patients With Prostate Cancer Before Radical Prostatectomy
A Single Arm Study of 6-Months Neoadjuvant Apalutamide Prior to Radical Prostatectomy in Intermediate Risk Patients to Reduce the Frequency of Pathologic Features That Drive Post-Operative Radiation Therapy
Sponsor: M.D. Anderson Cancer Center + National Cancer Institute (NCI)
No open prediction endpoints
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Primary Endpoints (CT.gov)
Number of Adverse Surgical Pathology Features at Risk of Pelvic Radiation Therapy
Time frame: Assessed at time of surgical specimen microscopic evalution Assessed at time of surgical specimen microscopic evaluation
Secondary Endpoints
Safety and Tolerability of 6 Months Neoadjuvant Apalutamide Followed by Radical Prostatectomy
Clinical Complete Responses (pT0) and "Near" Complete Responses (<6mm Total Tumor Volume)
Biochemical Recurrence Rate
Eligibility Criteria
Inclusion Criteria: * Willing and able to provide written informed consent * Histologically confirmed adenocarcinoma of the prostate * A minimum of 10 core biopsies have been performed at baseline and available. A prostate biopsy within 6 months from screening is allowed for entry requirements. Biopsies performed within 6-12 months from screening are acceptable if the treating physician would allow treatment without further biopsy. Patients must meet intermediate risk criteria from Gleason score, T stage, and prostate-specific antigen (PSA) value by National Comprehensive Cancer Network (NCCN) criteria: cT2b-T2c or Gleason 7 (3+4 or 4+3) or PSA 10-20 ng/mL. In addition, the Gleason 3+4 or 4+3 must be present * Pathology review at MD Anderson Cancer Center. The volume of disease must be high enough for the surgeon to agree to include an extended template pelvic lymph node dissection * Serum testosterone \> 200 ng/mL * Patient and urologist must agree that patient is suitable for prosta…
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