Clinical trial NCT05931419: High-Risk prostatE Cancer radiatiOn Versus surgERy
Official title: High-Risk prostatE Cancer radiatiOn Versus surgERy (RECOVER)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Cancer
Prostate Adenocarcinoma
Keywords: Radical prostatectomy
Radiotherapy
Health-related quality of life
Functional outcomes
Progression-free survival
Distant metastases-free survival
Cost-effectiveness
Lead sponsor: Comprehensive Cancer Centre The Netherlands
Sponsor class: OTHER
First posted: 2023-07-05
Enrollment: 837
Sex: MALE
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with de novo non-metastatic high-risk prostate cancer (cT3a-bN0M0 and/or ISUP grade ≥4 and/or PSA \>20ng/ml), who have opted for treatment with RARP or EBRT and ADT and are diagnosed in, or are referred to one of the participating hospitals

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Functional outcomes
timeFrame: 3 years after treatment initiation
measure: Health-related quality of life (HRQoL)
timeFrame: 3 years after treatment initiation
Secondary outcomes:
measure: Cost-effectiveness
timeFrame: 3 years after treatment initiation
measure: Progression-free survival
timeFrame: 5 years after diagnosis
measure: Distant metastases-free survival
timeFrame: 5 years after diagnosis
Other outcomes:
Locations:
city: Alkmaar
country: Netherlands
facility: Noordwest Ziekenhuisgroep
city: Amstelveen
country: Netherlands
facility: Ziekenhuis Amstelland
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
city: Amsterdam
country: Netherlands
facility: Antoni van Leeuwenhoek Ziekenhuis
city: Amsterdam
country: Netherlands
facility: BovenIJ ziekenhuis
city: Amsterdam
country: Netherlands
facility: OLVG
city: Assen
country: Netherlands
facility: Wilhelmina Ziekenhuis
city: Beverwijk
country: Netherlands
facility: Rode Kruis Ziekenhuis
city: Den Haag
country: Netherlands
facility: Haaglanden Medisch Centrum
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Ziekenhuis
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Goes
country: Netherlands
facility: Admiraal de Ruyter Ziekenhuis
city: Groningen
country: Netherlands
facility: Martini ziekenhuis
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen
city: Hardenberg
country: Netherlands
facility: Saxenburgh Medisch Centrum
city: Harderwijk
country: Netherlands
facility: St Jansdal
city: Hoofddorp
country: Netherlands
facility: Spaarne Gasthuis
city: Hoogeveen
country: Netherlands
facility: Treant
city: Hoorn
country: Netherlands
facility: Dijklander Ziekenhuis
city: Leiden
country: Netherlands
facility: Leids Universitair Medisch Centrum
city: Nijmegen
country: Netherlands
facility: Canisius Wilhelmina Ziekenhuis
city: Nijmegen
country: Netherlands
facility: Radboudumc
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum Rotterdam
city: Rotterdam
country: Netherlands
facility: Franciscus Gasthuis & Vlietland
city: Rotterdam
country: Netherlands
facility: Maasstad Ziekenhuis
city: Scheemda
country: Netherlands
facility: Ommelander Ziekenhuis
city: Tilburg
country: Netherlands
facility: Verbeeten Instituut
city: Veldhoven
country: Netherlands
facility: Maxima Medisch Centrum
city: Zaandam
country: Netherlands
facility: Zaans Medisch Centrum
Study officials:
affiliation: Comprehensive Cancer Centre The Netherlands
name: Katja Aben, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Medical Center Groningen
name: Igle Jan de Jong, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Netherlands Cancer Institute/ Antoni van Leeuwenhoek
name: Floris Pos, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: