NCT04295447

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

A Randomized, Open-label, Phase 2 Study of Adjuvant Apalutamide or Standard of Care in Subjects With High-risk, Localized or Locally Advanced Prostate Cancer After Radical Prostatectomy

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 190 (estimated)
• Sponsor: Universität Münster · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Prostatic Neoplasms

Interventions

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

Timeline

• Start date: 2020-12-10
• Primary completion: 2028-11-30
• Completion: 2028-11-30
• First posted: 2020-03-04
• Last updated: 2024-06-20

Locations

21 sites across 2 countries: Austria, Germany