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RECRUITING
NCT05448547
PHASE3

Immediate Curative vs Conservative Treatment in Older Men With M0, High-risk Prostate Cancer

Sponsor: Sven Löffeler

View on ClinicalTrials.gov

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

RADIATION

Radiotherapy or surgery

see arm/ group description

OTHER

initial observation

see arm/ group description

DRUG

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