Trial Title:
High-Risk prostatE Cancer radiatiOn Versus surgERy
NCT ID:
NCT05931419
Condition:
Prostate Cancer
Prostate Adenocarcinoma
Conditions: Official terms:
Prostatic Neoplasms
Conditions: Keywords:
Radical prostatectomy
Radiotherapy
Health-related quality of life
Functional outcomes
Progression-free survival
Distant metastases-free survival
Cost-effectiveness
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
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
Sampling method:
Non-Probability Sample
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
Gender:
Male
Minimum age:
50 Years
Maximum age:
75 Years
Locations:
Facility:
Name:
Noordwest Ziekenhuisgroep
Address:
City:
Alkmaar
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Ziekenhuis Amstelland
Address:
City:
Amstelveen
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Amsterdam UMC
Address:
City:
Amsterdam
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Antoni van Leeuwenhoek Ziekenhuis
Address:
City:
Amsterdam
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
BovenIJ ziekenhuis
Address:
City:
Amsterdam
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
OLVG
Address:
City:
Amsterdam
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Wilhelmina Ziekenhuis
Address:
City:
Assen
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Rode Kruis Ziekenhuis
Address:
City:
Beverwijk
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Haaglanden Medisch Centrum
Address:
City:
Den Haag
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Albert Schweitzer Ziekenhuis
Address:
City:
Dordrecht
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Catharina Ziekenhuis
Address:
City:
Eindhoven
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Admiraal de Ruyter Ziekenhuis
Address:
City:
Goes
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Martini ziekenhuis
Address:
City:
Groningen
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Universitair Medisch Centrum Groningen
Address:
City:
Groningen
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Saxenburgh Medisch Centrum
Address:
City:
Hardenberg
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
St Jansdal
Address:
City:
Harderwijk
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Spaarne Gasthuis
Address:
City:
Hoofddorp
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Treant
Address:
City:
Hoogeveen
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Dijklander Ziekenhuis
Address:
City:
Hoorn
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Leids Universitair Medisch Centrum
Address:
City:
Leiden
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Canisius Wilhelmina Ziekenhuis
Address:
City:
Nijmegen
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Radboudumc
Address:
City:
Nijmegen
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Erasmus Medisch Centrum Rotterdam
Address:
City:
Rotterdam
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Franciscus Gasthuis & Vlietland
Address:
City:
Rotterdam
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Maasstad Ziekenhuis
Address:
City:
Rotterdam
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Ommelander Ziekenhuis
Address:
City:
Scheemda
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Verbeeten Instituut
Address:
City:
Tilburg
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Maxima Medisch Centrum
Address:
City:
Veldhoven
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Zaans Medisch Centrum
Address:
City:
Zaandam
Country:
Netherlands
Status:
Recruiting
Start date:
February 16, 2023
Completion date:
June 30, 2030
Lead sponsor:
Agency:
Comprehensive Cancer Centre The Netherlands
Agency class:
Other
Source:
Comprehensive Cancer Centre The Netherlands
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05931419
