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Age: 50Years - 75Years
MALE
ID05931419

Study Comparing Robot-Assisted Surgery and Radiotherapy Treatments for High-Risk Non-Metastatic Prostate Cancer in Men Aged 50 to 75

Led by Comprehensive Cancer Centre The Netherlands · Updated on 2026-05-22

837

Participants Needed

28

Research Sites

39 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are comparing robot-assisted radical prostatectomy RARP and external beam radiotherapy EBRT, sometimes combined with androgen deprivation therapy ADT, for men with high-risk non-metastatic prostate cancer. The study aims to understand differences in quality of life, functional outcomes, cost-effectiveness, progression-free survival, and distant metastasis-free survival. There is currently no clear consensus on which treatment is better, leading to variation in hospital practices. Participants will receive either RARP, which may include pelvic lymph node dissection and possibly adjuvant radiotherapy or androgen deprivation therapy, or EBRT delivered at an effective radiation dose, possibly combined with a brachytherapy boost and pelvic lymph node dissection. Positive lymph node findings will not exclude participants and may be treated with lymph node irradiation. Treatment details vary based on clinical decisions. During the study, participants will be followed for up to five years, with key assessments at three years including health-related quality of life and functional outcomes. Cost-effectiveness will also be evaluated at three years, while progression-free and distant metastasis-free survival will be tracked up to five years. The study involves regular monitoring to gather these outcomes and support shared decision-making for future patients.

CONDITIONS

Brief Title

High-Risk prostatE Cancer radiatiOn Versus surgERy

Research Team

B

Berdine Heesterman, MD, PhD

C

Caroline van der Starre, MSc

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