Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
837 participants
OBSERVATIONAL
2023-02-16
2030-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
External beam radiotherapy (EBRT) combined with 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 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. Patients should receive ADT for at least 6 months.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* Diagnosis and/or treatment in a hospital abroad
* Treatment with Androgen Receptor Targeted Agents (ARTA) as part of the initial treatment plan
50 Years
75 Years
MALE
No
Sponsors
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Comprehensive Cancer Centre The Netherlands
OTHER
Responsible Party
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Berdine Heesterman
Principal Investigator
Principal Investigators
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Katja Aben, PhD
Role: PRINCIPAL_INVESTIGATOR
Comprehensive Cancer Centre The Netherlands
Igle Jan de Jong, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Medical Center Groningen
Floris Pos, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Netherlands Cancer Institute/ Antoni van Leeuwenhoek
Locations
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Noordwest Ziekenhuisgroep
Alkmaar, , Netherlands
Ziekenhuis Amstelland
Amstelveen, , 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
Countries
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Central Contacts
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References
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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.
Other Identifiers
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2022-13682
Identifier Type: -
Identifier Source: org_study_id
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