RecruitingPhase 3NCT05448547

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


Sponsor

Sven Löffeler

Enrollment

980 participants

Start Date

Nov 4, 2022

Study Type

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

Sex: MALEMin Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two approaches for older men with high-risk prostate cancer that has not spread: immediate curative treatment (such as radiation or surgery) versus a more conservative "watch and wait" approach, to see which leads to better quality of life and outcomes in men 75 and older. **You may be eligible if...** - You are 75 years of age or older - You have been diagnosed with prostate cancer within the past 6 months - Your cancer has a high-risk Gleason score (grade group 4 or 5) or is locally advanced (T3 or T4 stage) - Your tumor is visible on MRI or can be felt on physical exam - You are in good overall health based on a medical and geriatric assessment **You may NOT be eligible if...** - Your cancer has spread to lymph nodes or distant organs (metastatic) - You are under 75 years old - Your overall health is too poor to tolerate treatment - You have already started treatment for prostate cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONRadiotherapy or surgery

see arm/ group description

OTHERinitial observation

see arm/ group description

DRUGHormone 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, 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

View Full Details on ClinicalTrials.gov

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NCT05448547


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