Immediate Curative vs Conservative Treatment in Older Men With M0, High-risk Prostate Cancer
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Study 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
Primary outcome measure(s)
- Overall survival — 10 years following end of recruitment
overall survival - Burden of disease — 0-10 years
European Organisation for Research and Treatment of Cancer questionnaire for assessment of health-related quality of life elderly patients with cancer (EORTC ELD 14), burden of disease scale (2 questions, score 0-100, high scores indicate high burden of disease)
Trial sites (26)
| Facility | City | Region | Status |
|---|---|---|---|
| Rigshospital | Copenhagen | Denmark | Recruiting |
| Esbjerg and Grindsted Hospital | Esbjerg | Denmark | Recruiting |
| Odense University Hospital | Odense | Denmark | Recruiting |
| Helsinki University Hospital | Helsinki | Finland | Recruiting |
| Tampere University Hospital | Tampere | Finland | Recruiting |
| Turku University Hospital | Turku | Finland | Recruiting |
| Sunmøre Hospital Trust | Ålesund | Møre og Romsdal | Recruiting |
| Stavanger University Hospital | Stavanger | Rogaland | Recruiting |
| Sørlandet Hospital Trust | Kristiansand | Sørlandet | Recruiting |
| Telemark Hospital Trust | Skien | Telemark | Recruiting |
| St. Olavs Hospital | Trondheim | Trøndelag | Recruiting |
| Vestfold Hospital Trust (Hospital of Vestfold) | Tønsberg | Vestfold | Recruiting |
| Vestre Viken Hospital Trust | Drammen | Norway | Recruiting |
| Innlandet Hospital Trust | Hamar | Norway | Recruiting |
| Akerhus University Hospital | Lørenskog | Norway | Recruiting |
| Oslo University Hospital | Oslo | Norway | Recruiting |
| University Hospital of Northern Norway | Tromsø | Norway | Recruiting |
| Falu Lasarett | Falun | Sweden | Recruiting |
| Sahlgrenska University Hospital | Gothenburg | Sweden | Recruiting |
| Helsingborg/Ängelholm hospital | Helsingborg | Sweden | Recruiting |
| Örebro University Hospital | Örebro | Sweden | Recruiting |
| Östersunds Hospital | Östersund | Sweden | Recruiting |
| Capio Saint Göran's Hospital | Stockholm | Sweden | Recruiting |
| Södersjukhuset | Stockholm | Sweden | Recruiting |
| Norrlands universitetssjukhus | Umeå | Sweden | Recruiting |
| Akademiska sjukhuset, Uppsala | Uppsala | Sweden | Recruiting |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05448547 on ClinicalTrials.gov ↗ ← All trials in Denmark