Protocol of a randomised, controlled trial comparing immediate curative therapy with conservative treatment in men aged ≥75 years with non-metastatic high-risk prostate cancer (SPCG 19/GRand-P).

Autor: Löffeler S; Department of Urology, Vestfold Hospital Trust, Tønsberg, Norway., Bertilsson H; Department of Clinical and Molecular Medicine, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.; Department of Urology, St. Olav's University Hospital, Trondheim, Norway., Müller C; Department of Oncology, Sørlandet Hospital Trust, Kristiansand, Norway., Aas K; Department of Urology, Akershus University Hospital, Lørenskog, Norway.; Institute of Clinical Medicine, University of Oslo, Oslo, Norway., Haugnes HS; Department of Oncology, University Hospital of North Norway, Tromsø, Norway.; Department of Clinical Medicine, The Arctic University of Norway (UIT), Tromsø, Norway., Aksnessæther B; Department of Oncology, Møre og Romsdal Hospital Trust, Ålesund, Norway., Pesonen M; Oslo Centre for Biostatistics and Epidemiology, Oslo University Hospital, Oslo, Norway., Thon K; Department of Oncology, Oslo University Hospital, Oslo, Norway., Tandstad T; Department of Clinical and Molecular Medicine, Faculty of Medicine and Health Science, Norwegian University of Science and Technology (NTNU), Trondheim, Norway.; Department of Oncology, The Cancer Clinic, St Olav's University Hospital, Trondheim, Norway., Murtola T; Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.; Department of Urology, Tampere University Hospital, Tampere, Finland., Poulsen MH; Department of Urology, Odense University Hospital, Odense, Denmark.; Institute of Clinical Research, University of Southern Denmark, Odense, Denmark., Nordstrøm T; Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden.; Department of Clinical Sciences at Danderyd Hospital, Karolinska Institutet, Stockholm, Sweden., Vigmostad MN; Department of Oncology, Stavanger University Hospital, Stavanger, Norway., Ottosson F; Department of Urology, Oslo University Hospital, Oslo, Norway., Holmsten K; Department of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden.; Department of Oncology, Capio St. Göran Hospital, Stockholm, Sweden., Christiansen O; Department of Urology, Innlandet Hospital Trust, Hamar, Norway., Slaaen M; Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway.; Research Centre for Age-Related Functional Decline and Disease, Innlandet Hospital Trust, Ottestad, Norway., Haug ES; Department of Urology, Vestfold Hospital Trust, Tønsberg, Norway., Storås AH; Department of Oncology, Oslo University Hospital, Oslo, Norway., Asphaug L; Institute of Health and Society, University of Oslo, Oslo, Norway.; Clinical Trials Unit, Oslo University Hospital, Oslo, Norway., Rannikko A; Department of Urology and Research Program in Systems Oncology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland., Brasso K; Copenhagen Prostate Cancer Center, Department of Urology, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark.; Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.
Jazyk: angličtina
Zdroj: BJU international [BJU Int] 2024 Jun; Vol. 133 (6), pp. 680-689. Date of Electronic Publication: 2024 Mar 12.
DOI: 10.1111/bju.16314
Abstrakt: Background: Older men (aged ≥75 years) with high risk, non-metastatic prostate cancer (PCa) are increasingly treated with curative therapy (surgery or radiotherapy). However, it is unclear if curative therapy prolongs life and improves health-related quality of life (HRQoL) in this age group compared to conservative therapy, which has evolved considerably during the last decade.
Study Design: The Scandinavian Prostate Cancer Group (SPCG) 19/Norwegian Get-Randomized Research Group-Prostate (GRand-P) is a randomised, two-armed, controlled, multicentre, phase III trial carried out at study centres in Norway, Denmark, Finland, and Sweden.
Endpoints: The primary endpoints are overall survival and HRQoL (burden of disease scale, European Organisation for the Research and Treatment of Cancer [EORTC] Elderly Cancer patients). Secondary endpoints are PCa-specific survival, metastasis-free survival, role-functioning scale (EORTC quality of life questionnaire 30-item core), urinary irritative/obstructive scale (26-item Expanded Prostate Cancer Index Composite [EPIC-26]), bowel scale (EPIC-26), intervention-free survival, PCa morbidity, use of secondary and tertiary systemic therapies, mean quality-adjusted life-years (QALYs), and mean total healthcare costs.
Patients and Methods: A total of 980 men (aged ≥75 years) with non-metastatic, high-risk PCa will initially be screened with Geriatric 8 (G8) health status screening tool and Mini-COG© brief cognitive test. Participants identified by G8 as 'fit' or 'frail' will be randomised (ratio 1:1) to either immediate curative therapy (radiotherapy or prostatectomy) or conservative therapy (endocrine therapy or observation). Participants who are unable or unwilling to participate in randomisation will be enrolled in a separate observation group. Randomised patients will be followed for 10 years.
Trial Registration: Ethics approval has been granted in Norway (457593), Denmark (H-22051998), Finland (R23043) and Sweden (Dnr 2023-05296-01). The trial is registered on Clinicaltrials.org (NCT05448547).
(© 2024 The Authors. BJU International published by John Wiley & Sons Ltd on behalf of BJU International.)
Databáze: MEDLINE
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