Cancer types
  • Urology
Title of study
Randomized trial for the evaluation of erectile dysfunction after whole or partial gland prostate brachytherapy
Version Number
Approval Date 
Version 3.1, 4 June 2018
Short Title
Power
Study site
Principle Investigator
Dr. B.R. Pieters Radiation Oncologist Academic Medical Center
Investigator Maastro
Dr. B. Vanneste
Sponsor
Academic Medical Center / University of Amsterdam Department of Radiation Oncology
Trial registry
Objectives 

The main objective is to assess if partial prostate brachytherapy will lead to less erectile dysfunction than whole gland prostate brachytherapy. Secondary objectives are: – To assess differences in urinary and rectal late effects between whole gland and partial prostate brachytherapy. – To assess differences in post-procedural quality of life measured by EORTC QLQ-C30 and QLQ-PR25 questionnaire. – To assess the local oncological efficacy as measured by the proportion of men who are free of local prostate cancer in the two different groups. This will be examined by standardized 12 core prostate biopsies and mpMRI.

Primary Endpoint 

Primary endpoint: deterioration of erectile function by assessment of the IIEF-5 score. A drop of at least 5 points compared to baseline value or a need to start with a phosphodiesterase 5 inhibitor (PDE5 inhibitor) (or other medical interventions to improve erections) at last follow-up is considered as an event. Coherent to the primary endpoint, alive with no relapse and no erectile dysfunction (according to the definition under primary endpoint) will be assessed.

Secondary Endpoints 

The incidence of late gastro-intestinal (GI) and genito-urinary (GU) toxicity (CTCAEv4 and IPSS), quality of life after treatment completion (EORTC QLQ-C30 and PR25), and progression of local disease histologically and radiological.