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)
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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). / Löffeler, Sven; Bertilsson, Helena; Müller, Christoph; Aas, Kirsti; Haugnes, Hege Sagstuen; Aksnessæther, Bjørg; Pesonen, Maiju; Thon, Kristian; Tandstad, Torgrim; Murtola, Teemu; Poulsen, Mads Hvid; Nordstrøm, Tobias; Vigmostad, Maria Nyre; Ottosson, Fredrik; Holmsten, Karin; Christiansen, Ola; Slaaen, Marit; Haug, Erik Skaaheim; Storås, Anne Holck; Asphaug, Lars; Rannikko, Antti; Brasso, Klaus; Scandinavian Prostatic Cancer Group (SPCG); Norwegian Get-Randomized (GRand) Initiative.
I: BJU International, Bind 133, Nr. 6, 2024, s. 680-689.Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › fagfællebedømt
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TY - JOUR
T1 - 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)
AU - Löffeler, Sven
AU - Bertilsson, Helena
AU - Müller, Christoph
AU - Aas, Kirsti
AU - Haugnes, Hege Sagstuen
AU - Aksnessæther, Bjørg
AU - Pesonen, Maiju
AU - Thon, Kristian
AU - Tandstad, Torgrim
AU - Murtola, Teemu
AU - Poulsen, Mads Hvid
AU - Nordstrøm, Tobias
AU - Vigmostad, Maria Nyre
AU - Ottosson, Fredrik
AU - Holmsten, Karin
AU - Christiansen, Ola
AU - Slaaen, Marit
AU - Haug, Erik Skaaheim
AU - Storås, Anne Holck
AU - Asphaug, Lars
AU - Rannikko, Antti
AU - Brasso, Klaus
AU - Scandinavian Prostatic Cancer Group (SPCG)
AU - Norwegian Get-Randomized (GRand) Initiative
N1 - Publisher Copyright: © 2024 The Authors. BJU International published by John Wiley & Sons Ltd on behalf of BJU International.
PY - 2024
Y1 - 2024
N2 - 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
AB - 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
KW - clinical trial
KW - curative treatment
KW - elderly patients
KW - geriatric oncology
KW - prostate cancer
U2 - 10.1111/bju.16314
DO - 10.1111/bju.16314
M3 - Journal article
C2 - 38469686
AN - SCOPUS:85187435107
VL - 133
SP - 680
EP - 689
JO - BJU International
JF - BJU International
SN - 1464-4096
IS - 6
ER -
ID: 387438488