Adjuvant Apalutamide in Subjects With High-risk Localized or Locally Advanced Prostate Cancer After Radical Prostatectomy

Sponsor
Universität Münster
Study ID
NCT04295447
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Standard of care — OTHER
    1. Observation only or 2. An optional adjuvant radiation of the prostate bed in case of positive surgical margin
  • Apalutamide 60Mg Tab — DRUG
    (4 x 60 mg) once daily on days 1-28 of a 28-day cycle

Study Details

The primary objective of this trial is to determine if adjuvant apalutamide in prostate cancer patients at high risk of developing subsequent metastatic disease results in prolonged biochemically recurrence-free survival after radical prostatectomy (RPE) in comparison to standard of care (SOC).

Key Dates

Start date
Dec 10, 2020
Status verified
Jun 2024
Primary completion
Nov 30, 2028
Completion
Nov 30, 2028

Study Design

Enrollment
190 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: Standard of care
    1. Observation only or 2. An optional adjuvant radiation of the prostate bed in case of positive surgical margin
  • Experimental: Apalutamide
    30 cycles apalutamide 240 mg (4 x 60 mg) once daily on days 1-28 of a 28-day cycle in addition to standard of care

Primary Outcome Measure

Progression-free survival (PFS). [ Time Frame: From date of randomization until the date of first documented progression (BCR or metastases) or date of death from any cause, whichever came first, assessed up to 7 years" ]

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