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Immediate Curative vs Conservative Treatment in Older Men With M0, High-risk Prostate Cancer
Sponsor: Sven Löffeler
Summary
It is currently unclear if immediate curative treatment (radiotherapy or surgery) of high-risk prostate cancer without metastasis in older men (\>=75 years) generates the same survival benefits as in younger patients or if the harms/ side-effects of immediate curative treatment outweigh the benefits. In this study the investigators randomize older patients with high-risk, non-metastatic high-risk prostate cancer to either immediate curative therapy or to conservative, more problem-oriented therapy to investigate if immediate curative treatment prolongs life, improves quality of life and is cost-effective.
Official title: A Randomized, Open-label, Multicenter, Parallel Group Treatment, Phase 3, Two-arm Study to Measure the Effect on Overall Survival and Quality of Life of Immediate Curative Therapy Compared With Standard Conservative Treatment in Older Male Participants Aged ≥ 75 Years With Non-metastatic, High-risk Prostate Cancer
Key Details
Gender
MALE
Age Range
75 Years - Any
Study Type
INTERVENTIONAL
Enrollment
980
Start Date
2022-11-04
Completion Date
2036-12-31
Last Updated
2025-07-01
Healthy Volunteers
Yes
Conditions
Interventions
Radiotherapy or surgery
see arm/ group description
initial observation
see arm/ group description
Hormone therapy
androgen depression therapy (ADT) by either LHRH agonist or antagonist or androgen monotherapy
Locations (18)
Rigshospital
Copenhagen, Denmark
Esbjerg and Grindsted Hospital
Esbjerg, Denmark
Odense University Hospital
Odense, Denmark
Helsinki University Hospital
Helsinki, Finland
Tampere University Hospital
Tampere, Finland
Turku University Hospital
Turku, Finland
Sunmøre Hospital Trust
Ålesund, Møre og Romsdal, Norway
Oslo University Hospital
Oslo, Oslo County, Norway
Stavanger University Hospital
Stavanger, Rogaland, Norway
Sørlandet Hospital Trust
Kristiansand, Sørlandet, Norway
Telemark Hospital Trust
Skien, Telemark, Norway
St. Olavs Hospital
Trondheim, Trøndelag, Norway
Vestfold Hospital Trust (Hospital of Vestfold)
Tønsberg, Vestfold, Norway
Vestre Viken Hospital Trust
Drammen, Norway
Innlandet Hospital Trust
Hamar, Norway
Akerhus University Hospital
Lørenskog, Norway
University Hospital of Northern Norway
Tromsø, Norway
Capio Saint Göran's Hospital
Stockholm, Sweden