RecruitingNCT05931419
High-Risk prostatE Cancer radiatiOn Versus surgERy
High-Risk prostatE Cancer radiatiOn Versus surgERy (RECOVER)
Sponsor
Comprehensive Cancer Centre The Netherlands
Enrollment
837 participants
Start Date
Feb 16, 2023
Study Type
OBSERVATIONAL
Conditions
Summary
Prospective cohort study comparing robot-assisted radical prostatectomy and external beam radiotherapy combined with 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
Sex: MALEMin Age: 50 YearsMax Age: 75 Years
Inclusion Criteria7
- 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 and ADT (WHO performance status 0-1)
- Living in the Netherlands
- Able to read and understand the Dutch language
Exclusion Criteria3
- 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
Locations(29)
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NCT05931419
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