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.
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.
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.
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.
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).
BJU international. 2024 Mar 12 [Epub ahead of print]
Sven Löffeler, Helena Bertilsson, Christoph Müller, Kirsti Aas, Hege Sagstuen Haugnes, Bjørg Aksnessaether, Maiju Pesonen, Kristian Thon, Torgrim Tandstad, Teemu Murtola, Mads Hvid Poulsen, Tobias Nordstrøm, Maria Nyre Vigmostad, Fredrik Ottosson, Karin Holmsten, Ola Christiansen, Marit Slaaen, Erik Skaaheim Haug, Anne Holck Storås, Lars Asphaug, Antti Rannikko, Klaus Brasso, Scandinavian Prostate Cancer Group (SPCG) and the Norwegian Get-Randomized (GRand) Initiative
Department of Urology, Vestfold Hospital Trust, Tønsberg, Norway., Department of Clinical and Molecular Medicine, Norwegian University of Science and Technology (NTNU), Trondheim, Norway., Department of Oncology, Sørlandet Hospital Trust, Kristiansand, Norway., Department of Urology, Akershus University Hospital, Lørenskog, Norway., Department of Oncology, University Hospital of North Norway, Tromsø, Norway., Department of Oncology, Møre og Romsdal Hospital Trust, Ålesund, Norway., Oslo Centre for Biostatistics and Epidemiology, Oslo University Hospital, Oslo, Norway., Department of Oncology, Oslo University Hospital, Oslo, Norway., Department of Clinical and Molecular Medicine, Faculty of Medicine and Health Science, Norwegian University of Science and Technology (NTNU), Trondheim, Norway., Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland., Department of Urology, Odense University Hospital, Odense, Denmark., Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden., Department of Oncology, Stavanger University Hospital, Stavanger, Norway., Department of Urology, Oslo University Hospital, Oslo, Norway., Department of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden., Department of Urology, Innlandet Hospital Trust, Hamar, Norway., Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway., Institute of Health and Society, University of Oslo, Oslo, Norway., Department of Urology and Research Program in Systems Oncology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland., Copenhagen Prostate Cancer Center, Department of Urology, Copenhagen University Hospital-Rigshospitalet, Copenhagen, Denmark.