High-Risk prostatE Cancer radiatiOn Versus surgERy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age50-75
SponsorComprehensive Cancer Centre The Netherlands
About this trial
Prospective cohort study comparing robot-assisted radical prostatectomy and external beam radiotherapy +/- androgen deprivation therapy for high-risk non-metastatic prostate cancer in terms of health-related quality of life, functional outcomes, cost-effectiveness, progression-free survival and distant metastasis-free survival.
Eligibility criteria
Qualifiers
Histologically confirmed de novo non-metastatic high-risk prostate cancer.
cT3a-bN0M0, according to the 8th edition of the Tumour, Node, Metastasis (TNM) classification, with the exception that clinical T-stage will be based on digital rectal examination and magnetic resonance imaging (the highest stage will be used) and/or
International Society of Urological Pathology (ISUP) grade ≥4 and/or
Prostate-Specific Antigen (PSA) value at diagnosis greater than 20 ng/mL
Disqualifiers
Histological types other than adenocarcinoma
Diagnosis and/or treatment in a hospital abroad
Treatment with Androgen Receptor Targeted Agents (ARTA) as part of the initial treatment plan
Trial design
Treatments tested in this trial
- Not listed
Trial groups
837 Participants
are grouped into 2 trial groupsLocations
28Noordwest Ziekenhuisgroep Alkmaar Netherlands
Amsterdam UMC Amsterdam Netherlands
Antoni van Leeuwenhoek Ziekenhuis Amsterdam Netherlands
BovenIJ ziekenhuis Amsterdam Netherlands
Sponsors and collaborators
Comprehensive Cancer Centre The Netherlands
Lead sponsor
Source ClinicalTrials.gov