Immediate Curative vs Conservative Treatment in Older Men With M0, High-risk Prostate Cancer
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
Sven Löffeler
980 participants
Nov 4, 2022
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
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Interventions
see arm/ group description
see arm/ group description
androgen depression therapy (ADT) by either LHRH agonist or antagonist or androgen monotherapy
Locations(18)
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NCT05448547