High-Risk prostatE Cancer radiatiOn Versus surgERy
Recruiting
Observational Study
Prostate CancerProstate Adenocarcinoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
50 – 75
Sex
Male
Study type
Observational
Participants needed
837 (estimated)
Sponsor
Comprehensive Cancer Centre The Netherlands · Other
Who this trial is looking for
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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.
Trial Locations
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Eligibility Criteria
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 resonan…
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
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