High-Risk prostatE Cancer radiatiOn Versus surgERy
RECOVER
1 other identifier
observational
837
1 country
28
Brief Summary
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2023
Longer than P75 for all trials
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 16, 2023
CompletedFirst Submitted
Initial submission to the registry
April 26, 2023
CompletedFirst Posted
Study publicly available on registry
July 5, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2030
May 22, 2026
March 1, 2026
6.6 years
April 26, 2023
May 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Functional outcomes
Functional outcomes will be measured with the Expanded Prostate Cancer Index Composite Short Form (EPIC-26). The EPIC-26 consists of 5 domains: urinary incontinence, urinary irritation, bowel function, sexual function and hormonal function. Domain scores range from 0-100 (the higher the score the better the function) and the minimally clinically important difference (MCID) per domain is 6-9, 5-7, 4-6, 10-12 and 4-6, respectively.
3 years after treatment initiation
Health-related quality of life (HRQoL)
HRQoL will be measured with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30). The questionnaire includes five functional domains (physical, role, cognitive, emotional and social), three symptom domains (fatigue, pain, nausea and vomiting) and a global health/quality of life scale. In addition, there are six separate items assessing dyspnea, insomnia, appetite loss, constipation, diarrhea, and perceived financial impact. For each domain and single item measure, a score from 0 to 100 can be calculated. For the functional domains and the global score, higher scores indicate a higher level of functioning/ better quality of life. In contrast, for the symptom domains and single item measures, a higher score represents a higher level of symptomatology.
3 years after treatment initiation
Secondary Outcomes (3)
Cost-effectiveness
3 years after treatment initiation
Progression-free survival
5 years after diagnosis
Distant metastases-free survival
5 years after diagnosis
Study Arms (2)
Robot assisted radical prostatectomy (RARP)
Robot-assisted radical prostatectomy, potentially as part of multimodality therapy with adjuvant radiotherapy or with (neo)adjuvant androgen deprivation therapy. Pelvic lymph node dissection (PLND) may be performed for staging purposes. The presence of positive lymph nodes (pN1) upon PLND is not a reason for exclusion and may be followed by adjuvant treatment such as lymph node irradiation.
External beam radiotherapy (EBRT) +/- androgen deprivation therapy (ADT)
External beam radiotherapy (hypofractionated or conventionally fractionated) at a biologically effective dose converted to 2Gy fractions (α/β:1.5) of at least 76Gy. EBRT may also be combined with a brachytherapy boost and PLND may be performed for staging purposes. The presence of positive lymph nodes (pN1) upon PLND is not a reason for exclusion and lymph node irradiation may be performed.
Eligibility Criteria
Patients with de novo non-metastatic high-risk prostate cancer (cT3a-bN0M0 and/or ISUP grade ≥4 and/or PSA \>20ng/ml), who have opted for treatment with RARP or EBRT +/- ADT and are diagnosed in, or are referred to one of the participating hospitals
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
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
Related Publications (1)
van der Starre CM, Bangma CH, Bijlsma MJ, van den Bergh ACM, Kiemeney LALM, Kievit W, Vos K, Somford DM, Wildeman SM, Aben KKH, de Jong IJ, Pos FJ, Heesterman BL. External beam radiation therapy versus radical prostatectomy for high-risk prostate cancer: protocol of the RECOVER study. BMC Cancer. 2025 Jan 27;25(1):149. doi: 10.1186/s12885-025-13511-7.
PMID: 39871169DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Katja Aben, PhD
Comprehensive Cancer Centre The Netherlands
- PRINCIPAL INVESTIGATOR
Igle Jan de Jong, MD, PhD
University Medical Center Groningen
- PRINCIPAL INVESTIGATOR
Floris Pos, MD, PhD
Netherlands Cancer Institute/ Antoni van Leeuwenhoek
- PRINCIPAL INVESTIGATOR
Berdine Heesterman, MD, PhD
Comprehensive Cancer Centre The Netherlands
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 26, 2023
First Posted
July 5, 2023
Study Start
February 16, 2023
Primary Completion (Estimated)
September 30, 2029
Study Completion (Estimated)
June 30, 2030
Last Updated
May 22, 2026
Record last verified: 2026-03