High-Risk prostatE Cancer radiatiOn Versus surgERy

Официальное название

High-Risk prostatE Cancer radiatiOn Versus surgERy (RECOVER)

Обзор

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.

Подробное описание

Detailed description: Robot assisted radical prostatectomy (RARP) and external beam radiotherapy (EBRT) often 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.

Первичные конечные точки

• Functional outcomes [Срок оценки: 3 years after treatment initiation]
• Health-related quality of life (HRQoL) [Срок оценки: 3 years after treatment initiation]

Вторичные конечные точки (3)

• Cost-effectiveness [Срок оценки: 3 years after treatment initiation]
• Progression-free survival [Срок оценки: 5 years after diagnosis]
• Distant metastases-free survival [Срок оценки: 5 years after diagnosis]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Нидерланды · 28 центров

• Noordwest Ziekenhuisgroep — Alkmaar
• Amsterdam UMC — Amsterdam
• Antoni van Leeuwenhoek Ziekenhuis — Amsterdam
• BovenIJ ziekenhuis — Amsterdam
• OLVG — Amsterdam
• Wilhelmina Ziekenhuis — Assen
• Rode Kruis Ziekenhuis — Beverwijk
• Albert Schweitzer Ziekenhuis — Dordrecht
• … и ещё 20 центров

Публикации

• 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 39871169

Идентификаторы

NCT: NCT05931419 · 2022-13682

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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