Cancer types
  • Urology
Title of study
Randomized Phase 3 Study On The Assessment Of Late Toxicity By Comparing IMRT High Dose External Beam Radiotherapy Only With External Beam Radiotherapy Combined With HDR Or PDR Brachytherapy In Patients With Intermediate/high Risk Prostate Cancer
Version Number
Approval Date 
1.4, 1 August 2017
Short Title
Study site
Principle Investigator
M.E.M.C. Christianen
Investigator Maastro
Dr B. Vanneste
Erasmus MC, Dept. of Radiotherapy
Trial registry

The primary study objective is to show a 50% reduction of the incidence of long-term gastrointestinal and genito-urinary toxicity in the treatment of prostate cancer in the intermediate and high risk group, by treatment with EBRT followed/ preceded by brachytherapy (EBRT+BRACHY), compared to treatment with EBRT alone (EBRT). Secondary objectives are to investigate the effect of this combined treatment on acute toxicity, tumour control, Quality of Life (QOL), overall survival, costs and costeffectiveness compared to standard treatment with EBRT alone

Primary Endpoint 

The incidence of late gastro-intestinal and genito-urinary toxicity (grade ≥ 2 RTOG) during 3 years of follow-up after treatment completion

Secondary Endpoints 

Incidence of acute toxicity, bDFS, RFS, OS, QOL, costs and cost-effectiveness (all costs of treatment and during 5 years of FU after treatment completion)