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

Prior treatment

• Dementia (unable to consent) Prior/Concomitant Therapy
• Prior radiation to the pelvis
• Hormone therapy \>3 months prior to randomization Diagnostic assessments

Other illness

• Medical Conditions

Other

• 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)

• 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.