Immediate treatment versus watchful care for older men with prostate cancer
Compares immediate radiotherapy or surgery with conservative care in men 75 or older.
Plain-language title generated from the registry record
Registry title: Immediate Curative vs Conservative Treatment in Older Men With M0, High-risk Prostate Cancer
Key facts
- Where
- Copenhagen, Esbjerg, and Odense, DenmarkSee the 3 sites
- Phase
- Phase 3
Where in Denmark
- RigshospitalCopenhagen, DenmarkTaking people
- Esbjerg and Grindsted HospitalEsbjerg, DenmarkTaking people
- Odense University HospitalOdense, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sven Löffeler
- Trial code
- NCT05448547
- Record updated
- 10 September 2026
- Original 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.Read full original descriptionShow less
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
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.
Inclusion: Participant must be 75 years of age or older, at the time of signing the informed consent; 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); Male; 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: Dementia (unable to consent) Prior/Concomitant Therapy; Prior radiation to the pelvis; Hormone therapy >3 months prior to randomization Diagnostic assessments; Medical Conditions; 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); 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; Disabled or severe comorbidity (identified by G8 screening); Unable to read, understand or fill out HRQoL questionnaires (PROMS).