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dc.contributor.authorLöffeler, Sven
dc.contributor.authorBertilsson, Helena Maria
dc.contributor.authorMüller, Christoph Rainer
dc.contributor.authorAas, Kirsti
dc.contributor.authorHaugnes, Hege Sagstuen
dc.contributor.authorAksnessæther, Bjørg Yksnøy
dc.contributor.authorPesonen, Maiju
dc.contributor.authorThon, Kristian
dc.contributor.authorTandstad, Torgrim
dc.contributor.authorMurtola, Teemu
dc.contributor.authorPoulsen, Mads Hvid Aaberg
dc.contributor.authorNordstrøm, Tobias
dc.contributor.authorVigmostad, Maria Nyre
dc.contributor.authorOttosson, Fredrik
dc.contributor.authorHolmsten, Karin
dc.contributor.authorChristiansen, Ola B.
dc.contributor.authorSlaaen, Marit
dc.contributor.authorHaug, Erik Skaaheim
dc.contributor.authorStorås, Anne Holck
dc.contributor.authorAsphaug, Lars
dc.contributor.authorRannikko, Antti
dc.contributor.authorBrasso, Klaus
dc.date.accessioned2024-03-22T12:01:22Z
dc.date.available2024-03-22T12:01:22Z
dc.date.issued2024-03-12
dc.description.abstractBackground 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.<p> <p>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. <p>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. <p>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. <p>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).en_US
dc.identifier.citationLöffeler, Bertilsson, Müller, Aas, Haugnes, Aksnessæther, Pesonen, Thon, Tandstad, Murtola, Poulsen, Nordstrøm, Vigmostad, Ottosson, Holmsten, Christiansen, Slaaen, Haug, Storås, Asphaug, Rannikko, Brasso. 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). BJU International. 2024en_US
dc.identifier.cristinIDFRIDAID 2254673
dc.identifier.doi10.1111/bju.16314
dc.identifier.issn1464-4096
dc.identifier.issn1464-410X
dc.identifier.urihttps://hdl.handle.net/10037/33237
dc.language.isoengen_US
dc.publisherWileyen_US
dc.relation.journalBJU International
dc.rights.accessRightsopenAccessen_US
dc.rights.holderCopyright 2024 The Author(s)en_US
dc.rights.urihttps://creativecommons.org/licenses/by-nc/4.0en_US
dc.rightsAttribution-NonCommercial 4.0 International (CC BY-NC 4.0)en_US
dc.titleProtocol 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)en_US
dc.type.versionpublishedVersionen_US
dc.typeJournal articleen_US
dc.typeTidsskriftartikkelen_US
dc.typePeer revieweden_US


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Attribution-NonCommercial 4.0 International (CC BY-NC 4.0)
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