A Study of Apalutamide (Adjuvant Treatment) and Androgen Deprivation Therapy (ADT) in Participants Who Have Undergone Radical Prostatectomy (RP) for Non-metastatic Prostate Cancer and Who Are at High Risk for Metastases
A Multi-center, Open-label, Single-arm Phase 2 Study of the Adjuvant Treatment of Apalutamide and Androgen Deprivation Therapy (ADT) in Treatment-naïve Participants Who Have Undergone Radical Prostatectomy (RP) for Non-metastatic Prostate Cancer and Who Are at High Risk for Metastases
Sponsor: Janssen Research & Development, LLC
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Confirmed Biochemical Recurrence (BCR)-Free Rate at Month 24
Time frame: At Month 24
Sub-study: Percentage of Participants Who Maintained Testosterone Level Less Than (<) 50 Nanograms Per Deciliter (ng/dL) Through Day 28
Time frame: From Day -14 through Day 28
Secondary Endpoints
Confirmed Biochemical Recurrence (BCR)-Free Rate at Month 12
Serum Testosterone Recovery (>=150 ng/dL) at Months 18 and 24
Sub-study: Number of Participants With Treatment-emergent Adverse Events
Eligibility Criteria
Inclusion Criteria: * A candidate for radical prostatectomy (RP) or status post RP. Eligible to receive study intervention between Day 29 and Day 90 post-RP. Post RP prostate-specific antigen (PSA) of \<= 0.2 nanograms per milliliter (ng/mL). Has not received other treatment for prostate cancer * Have recovered from RP procedure and have had no worsening in cardiac risk in the peri-operative period per the clinical judgement of the investigator * Adequate organ function (hepatic, renal, hematologic and cerebral) determined at the discretion of the treating physician * Eastern Cooperative oncology Group (ECOG) Performance Status Score of 0 or 1 * Histologically confirmed adenocarcinoma of the prostate and categorized as high risk for recurrent prostate cancer. High risk can be defined based on PSA alone or biopsy or RP specimen as follows: PSA greater than or equal to (\>=) 20 ng/ml or; Gleason Score \>= 9 in any core on biopsy or; Gleason Score \>= 8 (4+4 or 5+3) in greater than (\>) …
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