High-Risk prostatE Cancer radiatiOn Versus surgERy

Prostate Cancer Clinical Trial

— RECOVER  

Official title:

High-Risk prostatE Cancer radiatiOn Versus surgERy (RECOVER)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05931419
• Other study ID #: 2022-13682
• Status: Recruiting
• Start date: February 16, 2023
• Est. completion date: June 30, 2030

Study information

• Verified date: July 2023
• Source: Comprehensive Cancer Centre The Netherlands
• Contact: Berdine Heesterman, MD, PhD
• Phone: +316 39 27 71 73
• Email: b.heesterman[@]iknl.nl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 837
• Est. completion date: June 30, 2030
• Est. primary completion date: June 30, 2028
• Gender: Male
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Adenocarcinoma
• Prostate Cancer
• Prostatic Neoplasms

Locations

Country	Name	City	State
Netherlands	Noordwest Ziekenhuisgroep	Alkmaar
Netherlands	Ziekenhuis Amstelland	Amstelveen
Netherlands	Amsterdam UMC	Amsterdam
Netherlands	Andros Clinics	Amsterdam
Netherlands	Antoni van Leeuwenhoek Ziekenhuis	Amsterdam
Netherlands	BovenIJ ziekenhuis	Amsterdam
Netherlands	OLVG	Amsterdam
Netherlands	Wilhelmina Ziekenhuis	Assen
Netherlands	Rode Kruis Ziekenhuis	Beverwijk
Netherlands	Haaglanden Medisch Centrum	Den Haag
Netherlands	Albert Schweitzer Ziekenhuis	Dordrecht
Netherlands	Catharina Ziekenhuis	Eindhoven
Netherlands	Admiraal de Ruyter Ziekenhuis	Goes
Netherlands	Martini ziekenhuis	Groningen
Netherlands	Universitair Medisch Centrum Groningen	Groningen
Netherlands	Saxenburgh Medisch Centrum	Hardenberg
Netherlands	St Jansdal	Harderwijk
Netherlands	Spaarne Gasthuis	Hoofddorp
Netherlands	Treant	Hoogeveen
Netherlands	Dijklander Ziekenhuis	Hoorn
Netherlands	Leids Universitair Medisch Centrum	Leiden
Netherlands	Canisius Wilhelmina Ziekenhuis	Nijmegen
Netherlands	Radboudumc	Nijmegen
Netherlands	Erasmus Medisch Centrum Rotterdam	Rotterdam
Netherlands	Franciscus Gasthuis & Vlietland	Rotterdam
Netherlands	Maasstad Ziekenhuis	Rotterdam
Netherlands	Ommelander Ziekenhuis	Scheemda
Netherlands	Zaans Medisch Centrum	Zaandam

Sponsors (1)

Lead Sponsor	Collaborator
Comprehensive Cancer Centre The Netherlands

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 years after treatment initiation
Primary	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.	3 years after treatment initiation
Secondary	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).	3 years after treatment initiation
Secondary	Progression-free survival		5 years after diagnosis
Secondary	Distant metastases-free survival		5 years after diagnosis