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Набира участници NCT05931419

High-Risk prostatE Cancer radiatiOn Versus surgERy

Заболявания: Prostate Cancer Prostate Adenocarcinoma

Спонсор: Comprehensive Cancer Centre The Netherlands

Налично на: БГ
Обобщение
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.
Описание
Detailed description: Robot assisted radical prostatectomy (RARP) and external beam radiotherapy (EBRT) often 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.
Кой може да участва
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 +/- 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
Места на провеждане 28
Нидерландия (28)
Noordwest Ziekenhuisgroep
Alkmaar
Amsterdam UMC
Amsterdam
Antoni van Leeuwenhoek Ziekenhuis
Amsterdam
BovenIJ ziekenhuis
Amsterdam
OLVG
Amsterdam
Wilhelmina Ziekenhuis
Assen
Rode Kruis Ziekenhuis
Beverwijk
Albert Schweitzer Ziekenhuis
Dordrecht
Catharina Ziekenhuis
Eindhoven
Admiraal de Ruyter Ziekenhuis
Goes
Martini ziekenhuis
Groningen
Universitair Medisch Centrum Groningen
Groningen
Saxenburgh Medisch Centrum
Hardenberg
St Jansdal
Harderwijk
Spaarne Gasthuis
Hoofddorp
Treant
Hoogeveen
Dijklander Ziekenhuis
Hoorn
Leids Universitair Medisch Centrum
Leiden
Canisius Wilhelmina Ziekenhuis
Nijmegen
Radboudumc
Nijmegen
Erasmus Medisch Centrum Rotterdam
Rotterdam
Franciscus Gasthuis & Vlietland
Rotterdam
Maasstad Ziekenhuis
Rotterdam
Ommelander Ziekenhuis
Scheemda
Haaglanden Medisch Centrum
The Hague
Verbeeten Instituut
Tilburg
Maxima Medisch Centrum
Veldhoven
Zaans Medisch Centrum
Zaandam
Технически детайли
Статус
Набира участници
Вид изследване
OBSERVATIONAL
Пол
Само мъже
Минимална възраст
50 Years
Максимална възраст
75 Years
Здрави доброволци
Не
Начална дата
16.02.2023
Крайна дата
30.06.2030
Регистрационен номер
NCT05931419
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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