Comparing surgery and radiation for high-risk prostate cancer
High-Risk prostatE Cancer radiatiOn Versus surgERy (RECOVER)
This study is testing whether surgery or radiation works better for men with high-risk prostate cancer and how each treatment affects their quality of life and health outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 837 (estimated) |
| Ages | 50 Years to 75 Years |
| Sex | Male |
| Sponsor | Comprehensive Cancer Centre The Netherlands Academic / other |
| Locations | 28 sites (Alkmaar and 27 other locations) |
| Trial ID | NCT05931419 on ClinicalTrials.gov |
What this trial studies
This observational study compares the outcomes of robot-assisted radical prostatectomy and external beam radiotherapy combined with androgen deprivation therapy in patients with high-risk non-metastatic prostate cancer. It aims to evaluate health-related quality of life, functional outcomes, cost-effectiveness, progression-free survival, and distant metastasis-free survival. The study addresses the lack of consensus on the optimal treatment approach for this patient population, providing insights that could inform clinical guidelines and shared decision-making. By analyzing data from multiple hospitals, the study seeks to clarify treatment effectiveness and patient preferences.
Who should consider this trial
Good fit: Ideal candidates are men with histologically confirmed high-risk non-metastatic prostate adenocarcinoma who are fit for either surgical or radiotherapy treatment.
Not a fit: Patients with histological types other than adenocarcinoma or those who have received treatment abroad may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help determine the most effective treatment option for high-risk prostate cancer, improving patient outcomes and quality of life.
How similar studies have performed: Other studies have explored similar treatment comparisons, but this study aims to fill a specific knowledge gap regarding health-related quality of life and cost-effectiveness in this patient group.
Eligibility criteria
Show full inclusion / exclusion 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 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 this trial is running
Alkmaar and 27 other locations
- Noordwest Ziekenhuisgroep — Alkmaar, Netherlands (Recruiting)
- Amsterdam UMC — Amsterdam, Netherlands (Recruiting)
- Antoni van Leeuwenhoek Ziekenhuis — Amsterdam, Netherlands (Recruiting)
- BovenIJ ziekenhuis — Amsterdam, Netherlands (Recruiting)
- Olvg — Amsterdam, Netherlands (Recruiting)
- Wilhelmina Ziekenhuis — Assen, Netherlands (Recruiting)
- Rode Kruis Ziekenhuis — Beverwijk, Netherlands (Recruiting)
- Albert Schweitzer Ziekenhuis — Dordrecht, Netherlands (Recruiting)
- Catharina Ziekenhuis — Eindhoven, Netherlands (Recruiting)
- Admiraal de Ruyter Ziekenhuis — Goes, Netherlands (Recruiting)
- Martini ziekenhuis — Groningen, Netherlands (Recruiting)
- Universitair Medisch Centrum Groningen — Groningen, Netherlands (Recruiting)
- Saxenburgh Medisch Centrum — Hardenberg, Netherlands (Recruiting)
- St Jansdal — Harderwijk, Netherlands (Recruiting)
- Spaarne Gasthuis — Hoofddorp, Netherlands (Recruiting)
- Treant — Hoogeveen, Netherlands (Recruiting)
- Dijklander Ziekenhuis — Hoorn, Netherlands (Recruiting)
- Leids Universitair Medisch Centrum — Leiden, Netherlands (Recruiting)
- Canisius Wilhelmina Ziekenhuis — Nijmegen, Netherlands (Recruiting)
- Radboudumc — Nijmegen, Netherlands (Recruiting)
- Erasmus Medisch Centrum Rotterdam — Rotterdam, Netherlands (Recruiting)
- Franciscus Gasthuis & Vlietland — Rotterdam, Netherlands (Recruiting)
- Maasstad Ziekenhuis — Rotterdam, Netherlands (Recruiting)
- Ommelander Ziekenhuis — Scheemda, Netherlands (Recruiting)
- Haaglanden Medisch Centrum — The Hague, Netherlands (Recruiting)
- Verbeeten Instituut — Tilburg, Netherlands (Recruiting)
- Maxima Medisch Centrum — Veldhoven, Netherlands (Recruiting)
- Zaans Medisch Centrum — Zaandam, Netherlands (Recruiting)
Study contacts
- Principal investigator: Katja Aben, PhD — Comprehensive Cancer Centre The Netherlands
- Study coordinator: Berdine Heesterman, MD, PhD
- Email: b.heesterman@iknl.nl
- Phone: 316 39 27 71 73
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.