RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Sven Löffeler • ClinicalTrials.gov ID: NCT05448547

Registry updated: 2026-09-10

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Description

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.

Interventions

Radiotherapy or surgery (Radiation)
see arm/ group description
initial observation (Other)
see arm/ group description
Hormone therapy (Drug)
androgen depression therapy (ADT) by either LHRH agonist or antagonist or androgen monotherapy

Eligibility criteria

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)

Conditions

Prostate Cancer

Locations

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
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
Oslo University Hospital — Oslo, Norway
University Hospital of Northern Norway — Tromsø, Norway
Falu Lasarett — Falun, Sweden
Sahlgrenska University Hospital — Gothenburg, Sweden
Helsingborg/Ängelholm hospital — Helsingborg, Sweden
Örebro University Hospital — Örebro, Sweden
Östersunds Hospital — Östersund, Sweden
Capio Saint Göran's Hospital — Stockholm, Sweden
Södersjukhuset — Stockholm, Sweden
Norrlands universitetssjukhus — Umeå, Sweden
Akademiska sjukhuset, Uppsala — Uppsala, Sweden

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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