High-Risk prostatE Cancer radiatiOn Versus surgERy
Recruiting · NCT05931419 · Observational (researchers observe without assigning treatment) · Lead sponsor: Comprehensive Cancer Centre The Netherlands
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
50 Years to 75 Years
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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
- Fit for treatment with either RARP or EBRT +/- ADT (WHO performance status 0-1)
- Living in the Netherlands
- Able to read and understand the Dutch language
Exclusion criteria
- 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
Where it is running
28 locations listed.
- Noordwest Ziekenhuisgroep - Alkmaar, Netherlands
- Amsterdam UMC - Amsterdam, Netherlands
- Antoni van Leeuwenhoek Ziekenhuis - Amsterdam, Netherlands
- BovenIJ ziekenhuis - Amsterdam, Netherlands
- OLVG - Amsterdam, Netherlands
- Wilhelmina Ziekenhuis - Assen, Netherlands
- Rode Kruis Ziekenhuis - Beverwijk, Netherlands
- Albert Schweitzer Ziekenhuis - Dordrecht, Netherlands
- Catharina Ziekenhuis - Eindhoven, Netherlands
- Admiraal de Ruyter Ziekenhuis - Goes, Netherlands
- Martini ziekenhuis - Groningen, Netherlands
- Universitair Medisch Centrum Groningen - Groningen, Netherlands
- Saxenburgh Medisch Centrum - Hardenberg, Netherlands
- St Jansdal - Harderwijk, Netherlands
- Spaarne Gasthuis - Hoofddorp, Netherlands
- Treant - Hoogeveen, Netherlands
- Dijklander Ziekenhuis - Hoorn, Netherlands
- Leids Universitair Medisch Centrum - Leiden, Netherlands
- Canisius Wilhelmina Ziekenhuis - Nijmegen, Netherlands
- Radboudumc - Nijmegen, Netherlands
- Erasmus Medisch Centrum Rotterdam - Rotterdam, Netherlands
- Franciscus Gasthuis & Vlietland - Rotterdam, Netherlands
- Maasstad Ziekenhuis - Rotterdam, Netherlands
- Ommelander Ziekenhuis - Scheemda, Netherlands
- Haaglanden Medisch Centrum - The Hague, Netherlands
- Verbeeten Instituut - Tilburg, Netherlands
- Maxima Medisch Centrum - Veldhoven, Netherlands
- Zaans Medisch Centrum - Zaandam, Netherlands