Clinical trial · Observational
High-Risk prostatE Cancer radiatiOn Versus surgERy
High-Risk prostatE Cancer radiatiOn Versus surgERy (RECOVER)
NCT05931419CI-TRIAL-00112334RECOVERrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Adenocarcinoma | Prostate Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Robot assisted radical prostatectomy (RARP)
- description
- 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.
- label
- External beam radiotherapy (EBRT) +/- androgen deprivation therapy (ADT)
- description
- 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.
Primary outcomes (2)
- measure
- Functional outcomes
- timeFrame
- 3 years after treatment initiation
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 50 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDvan 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 39871169