High-Risk prostatE Cancer radiatiOn Versus surgERy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age50-75
SponsorComprehensive Cancer Centre The Netherlands
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial 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 +/- ADT and are diagnosed in, or are referred to one of the participating hospitals
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
837 Participants
are grouped into 2 trial groupsGroup A: Robot assisted radical prostatectomy (RARP)
Group B: External beam radiotherapy (EBRT) +/- androgen deprivation therapy (ADT)
Trial outcomes
Primary outcomes
1
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 initiation2
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 initiationSecondary outcomes
1
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 initiation2
Progression-free survival
Time frame
5 years after diagnosis3
Distant metastases-free survival
Time frame
5 years after diagnosisSponsors and contacts
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Source ClinicalTrials.gov