High-Risk prostatE Cancer radiatiOn Versus surgERy

Comprehensive Cancer Centre The Netherlands837 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

837

Conditions

Prostate Cancer Prostate Adenocarcinoma

Eligibility

Sex: MALEMin age: 50 YearsMax age: 75 Years

Medical Language ↔ Plain English

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 and 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

Locations (29)

Outcomes

Primary Outcomes

Functional outcomes

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.

Time frame: 3 years after treatment initiation

Health-related quality of life (HRQoL)

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.

Time frame: 3 years after treatment initiation

Secondary Outcomes

Cost-effectiveness

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).

Time frame: 3 years after treatment initiation

Progression-free survival

Central Contacts

Berdine Heesterman, MD, PhD

CONTACT

316 39 27 71 73 b.heesterman@iknl.nl

Caroline van der Starre, MSc

CONTACT

31 6 4320 2647 c.vanderstarre@iknl.nl

Data from ClinicalTrials.gov

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