Immediate Curative vs Conservative Treatment in Older Men With M0, 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 cos

Trial Details

NCT ID
NCT05448547
Phase
PHASE3
Sponsor
Sven Löffeler
Status
RECRUITING
Cancer Type
Prostate Cancer
Interventions
  • Radiotherapy or surgery
  • initial observation
  • Hormone therapy
Locations (sample)
  • Copenhagen, Denmark|55.67594,12.56553
  • Esbjerg, Denmark|55.47028,8.45187
  • Odense, Denmark|55.39594,10.38831
  • Helsinki, Finland|60.16952,24.93545
  • Tampere, Finland|61.49911,23.78712

Key Eligibility Criteria

  • 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; …
  • 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…

For full eligibility, visit ClinicalTrials.gov.

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