MedTrace Logo

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

NCT04295447 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2024-06-20

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Janssen Pharmaceutica N.V., Belgium

    collaborator INDUSTRY

  • Universität Münster

    lead OTHER

Principal Investigators

  • Martin Bögemann, Univ.-Prof. Dr. med. · Universitätsklinikum Münster, Klinik für Urologie und Kinderurologie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-10
Primary Completion
2028-11-30
Completion
2028-11-30

Countries

  • Austria
  • Germany

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04295447 on ClinicalTrials.gov