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Recruiting Phase 3

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

NCT05448547 · tracked via the Priya Life Science Denmark tracker
Sponsor
Sven Löffeler
Phase
Phase 3
Started
2022-11-04
Last updated
2026-09-10

Condition(s) studied

Prostate Cancer

Investigational drug(s) / intervention(s)

Radiotherapy or surgeryinitial observationHormone therapy

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

Sex
MALE
Min age
75 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: 1. Participant must be 75 years of age or older, at the time of signing the informed consent. 2. Participants who are healthy as determined by medical evaluation and geriatric G8/ miniCOGTM evaluation (G8: Fit, score \>14, or reversibly frail; miniCOGTM: score \>2) And who have PCa (diagnosed ≤6 months) with one or both of the following features: * Gleason grade 8-10 (ISUP group 4 and 5) other than microscopic, low-volume disease (tumor must be either palpable or visible on MRI, i.e., PIRADS 4 or 5) * Locally advanced PCa (T3 or T4) (unequivocal findings of clinical/ radiological T3 or clinical/ radiological T4 on DRE or MRI; broad capsular contact of tumor on MRI is treated as localized disease, T2, in the context of this study) * Able to read, understand and fill in HRQoL questionnaires (PROMS) 3. Male 4. Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Exclusion Criteria: Medical Conditions 1. Dementia (unable to consent) Prior/Concomitant Therapy 2. Prior radiation to the pelvis 3. Hormone therapy \>3 months prior to randomization Diagnostic assessments 4. Lymph node metastasis (N0) on MRI, CT or PSMA-PET CT (equivocal N-findings =N0; borderline cases will be discussed and called by a study tumor board). 5. Distant metastasis (M0) on MRI, CT, bone scan or PSMA-PET CT (equivocal bone scan findings need to be confirmed with MRI or CT; borderline cases will be discussed by a study tumor board). Other Exclusions 6. Disabled or severe comorbidity (identified by G8 screening) 7. Unable to read, understand or fill out HRQoL questionnaires (PROMS)

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)

FacilityCityRegionStatus
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
Official registry record

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