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NCT Number: NCT05931419

High-Risk prostatE Cancer radiatiOn Versus surgERy

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostate Adenocarcinoma Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

50 year–75 year

Sex eligibility

Male

Study type

Observational

Primary location

Noordwest Ziekenhuisgroep, Alkmaar, Netherlands

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Functional outcomes

    Time frame: 3 years after treatment initiation

    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.

  2. Health-related quality of life (HRQoL)

    Time frame: 3 years after treatment initiation

    HRQoL will be measured with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC-QLQ-C30). The questionnaire includes five functional domains (physical, role, cognitive, emotional and social), three symptom domains (fatigue, pain, nausea and vomiting) and a global health/quality of life scale. In addition, there are six separate items assessing dyspnea, insomnia, appetite loss, constipation, diarrhea, and perceived financial impact. For each domain and single item measure, a score from 0 to 100 can be calculated. For the functional domains and the global score, higher scores indicate a higher level of functioning/ better quality of life. In contrast, for the symptom domains and single item measures, a higher score represents a higher level of symptomatology.

Secondary outcomes

  1. Cost-effectiveness

    Time frame: 3 years after treatment initiation

    A cost-utility analysis (CUA) will be conducted from a societal and medical perspective. The societal perspective will specifically focus on the patients out of pocket costs. Utilities will be derived by means of a mapping algorithm for the EORTC QLQ-C30. The derived utility will be used to estimate a Quality adjusted life year (QALY) according to the trapezium rule. Incremental costs between EBRT combined with ADT and RARP will be related to incremental QALYs in a cost-utility ratio (ICUR).

  2. Progression-free survival

    Time frame: 5 years after diagnosis

  3. Distant metastases-free survival

    Time frame: 5 years after diagnosis

Study contacts

Contact information is provided by the study sponsor or research team.

Berdine Heesterman, MD, PhD

CONTACT

[email protected]

316 39 27 71 73

Caroline van der Starre, MSc

CONTACT

[email protected]

31 6 4320 2647

Sponsors and collaborators

Lead sponsor

Comprehensive Cancer Centre The Netherlands

Other

Registry information

Official study title

High-Risk prostatE Cancer radiatiOn Versus surgERy (RECOVER)

Acronym: RECOVER

Important dates

Study start
2023
Primary completion
2029
Study completion
2030
First posted
Jul 5, 2023
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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