High-Risk prostatE Cancer radiatiOn Versus surgERy (RECOVER)

Status: Recruiting
Location: See all (29) locations...
Study Type: Observational
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
Participation Requirements
Sex: Male
Minimum Age: 50
Maximum Age: 75
View:

• 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

Locations
Other Locations
Netherlands
Noordwest Ziekenhuisgroep
RECRUITING
Alkmaar
Ziekenhuis Amstelland
RECRUITING
Amstelveen
Amsterdam UMC
RECRUITING
Amsterdam
Antoni van Leeuwenhoek Ziekenhuis
RECRUITING
Amsterdam
BovenIJ ziekenhuis
RECRUITING
Amsterdam
OLVG
RECRUITING
Amsterdam
Wilhelmina Ziekenhuis
RECRUITING
Assen
Rode Kruis Ziekenhuis
RECRUITING
Beverwijk
Albert Schweitzer Ziekenhuis
RECRUITING
Dordrecht
Catharina Ziekenhuis
RECRUITING
Eindhoven
Admiraal de Ruyter Ziekenhuis
RECRUITING
Goes
Martini ziekenhuis
RECRUITING
Groningen
Universitair Medisch Centrum Groningen
RECRUITING
Groningen
Saxenburgh Medisch Centrum
RECRUITING
Hardenberg
St Jansdal
RECRUITING
Harderwijk
Spaarne Gasthuis
RECRUITING
Hoofddorp
Treant
RECRUITING
Hoogeveen
Dijklander Ziekenhuis
RECRUITING
Hoorn
Leids Universitair Medisch Centrum
RECRUITING
Leiden
Canisius Wilhelmina Ziekenhuis
RECRUITING
Nijmegen
Radboudumc
RECRUITING
Nijmegen
Erasmus Medisch Centrum Rotterdam
RECRUITING
Rotterdam
Franciscus Gasthuis & Vlietland
RECRUITING
Rotterdam
Maasstad Ziekenhuis
RECRUITING
Rotterdam
Ommelander Ziekenhuis
RECRUITING
Scheemda
Haaglanden Medisch Centrum
RECRUITING
The Hague
Verbeeten Instituut
RECRUITING
Tilburg
Maxima Medisch Centrum
RECRUITING
Veldhoven
Zaans Medisch Centrum
RECRUITING
Zaandam
Contact Information
Primary
Berdine Heesterman, MD, PhD
b.heesterman@iknl.nl
316 39 27 71 73
Backup
Caroline van der Starre, MSc
c.vanderstarre@iknl.nl
31 6 4320 2647
Time Frame
Start Date: 2023-02-16
Estimated Completion Date: 2030-06-30
Participants
Target number of participants: 837
Treatments
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) 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.
Related Therapeutic Areas
Prostatectomy
Prostate Cancer
Sponsors
Leads: Comprehensive Cancer Centre The Netherlands

This content was sourced from clinicaltrials.gov

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