High-Risk prostatE Cancer radiatiOn Versus surgERy

Last updated: September 3, 2024
Sponsor: Comprehensive Cancer Centre The Netherlands
Overall Status: Active - Recruiting

Phase

N/A

Condition

Prostate Disorders

Prostate Cancer, Early, Recurrent

Urologic Cancer

Treatment

N/A

Clinical Study ID

NCT05931419
2022-13682
  • Ages 50-75
  • Male

Study 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 Criteria

Inclusion

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 digitalrectal 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

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 initialtreatment plan

Study Design

Total Participants: 837
Study Start date:
February 16, 2023
Estimated Completion Date:
June 30, 2030

Study Description

Detailed description: Robot assisted radical prostatectomy (RARP) and external beam radiotherapy (EBRT) combined with Androgen Deprivation Therapy (ADT) are widely used treatment modalities for high-risk non-metastatic prostate cancer (HR-PCa). Both treatments are associated with adverse effects and can have a great impact on health-related quality of life (HRQoL). To date there is no consensus on which of both is the optimal treatment for men with HR-PCa, as it is unclear which treatment is superior in terms of HRQoL, cost-effectiveness, progression-free survival (PFS) and distant metastases-free survival (DMFS). This is reflected in substantial variation between individual hospitals in the utilization of both treatment options that is not explained by patient- and tumor characteristics or patient preferences. In the RECOVER study we aim to address this knowledge gap. The insights gained can be used to tailor recommendations in (national) guidelines and in shared decision-making tools. This allows healthcare professionals to better inform their patients and allows patients to make well-informed choices.

Connect with a study center

  • Noordwest Ziekenhuisgroep

    Alkmaar,
    Netherlands

    Active - Recruiting

  • Ziekenhuis Amstelland

    Amstelveen,
    Netherlands

    Active - Recruiting

  • Amsterdam UMC

    Amsterdam,
    Netherlands

    Active - Recruiting

  • Andros Clinics

    Amsterdam,
    Netherlands

    Site Not Available

  • Antoni van Leeuwenhoek Ziekenhuis

    Amsterdam,
    Netherlands

    Active - Recruiting

  • BovenIJ ziekenhuis

    Amsterdam,
    Netherlands

    Active - Recruiting

  • OLVG

    Amsterdam,
    Netherlands

    Active - Recruiting

  • Wilhelmina Ziekenhuis

    Assen,
    Netherlands

    Active - Recruiting

  • Rode Kruis Ziekenhuis

    Beverwijk,
    Netherlands

    Active - Recruiting

  • Haaglanden Medisch Centrum

    Den Haag,
    Netherlands

    Active - Recruiting

  • Albert Schweitzer Ziekenhuis

    Dordrecht,
    Netherlands

    Active - Recruiting

  • Catharina Ziekenhuis

    Eindhoven,
    Netherlands

    Active - Recruiting

  • Admiraal de Ruyter Ziekenhuis

    Goes,
    Netherlands

    Active - Recruiting

  • Martini ziekenhuis

    Groningen,
    Netherlands

    Active - Recruiting

  • Universitair Medisch Centrum Groningen

    Groningen,
    Netherlands

    Active - Recruiting

  • Saxenburgh Medisch Centrum

    Hardenberg,
    Netherlands

    Active - Recruiting

  • St Jansdal

    Harderwijk,
    Netherlands

    Active - Recruiting

  • Spaarne Gasthuis

    Hoofddorp,
    Netherlands

    Active - Recruiting

  • Treant

    Hoogeveen,
    Netherlands

    Active - Recruiting

  • Dijklander Ziekenhuis

    Hoorn,
    Netherlands

    Active - Recruiting

  • Leids Universitair Medisch Centrum

    Leiden,
    Netherlands

    Active - Recruiting

  • Canisius Wilhelmina Ziekenhuis

    Nijmegen,
    Netherlands

    Active - Recruiting

  • Radboudumc

    Nijmegen,
    Netherlands

    Active - Recruiting

  • Erasmus Medisch Centrum Rotterdam

    Rotterdam,
    Netherlands

    Active - Recruiting

  • Franciscus Gasthuis & Vlietland

    Rotterdam,
    Netherlands

    Active - Recruiting

  • Maasstad Ziekenhuis

    Rotterdam,
    Netherlands

    Active - Recruiting

  • Ommelander Ziekenhuis

    Scheemda,
    Netherlands

    Active - Recruiting

  • Verbeeten Instituut

    Tilburg,
    Netherlands

    Active - Recruiting

  • Maxima Medisch Centrum

    Veldhoven,
    Netherlands

    Active - Recruiting

  • Zaans Medisch Centrum

    Zaandam,
    Netherlands

    Active - Recruiting

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