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
Status: Recruiting
Location: See all (18) locations...
Intervention Type: Other, Drug, Radiation
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: Male
Minimum Age: 75
Healthy Volunteers: t
View:
• 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.
Locations
Other Locations
Denmark
Rigshospital
RECRUITING
Copenhagen
Esbjerg and Grindsted Hospital
RECRUITING
Esbjerg
Odense University Hospital
RECRUITING
Odense
Finland
Helsinki University Hospital
RECRUITING
Helsinki
Tampere University Hospital
RECRUITING
Tampere
Turku University Hospital
RECRUITING
Turku
Norway
Sunmøre Hospital Trust
RECRUITING
Ålesund
Vestre Viken Hospital Trust
RECRUITING
Drammen
Innlandet Hospital Trust
RECRUITING
Hamar
Sørlandet Hospital Trust
RECRUITING
Kristiansand
Akerhus University Hospital
RECRUITING
Lørenskog
Oslo University Hospital
RECRUITING
Oslo
Telemark Hospital Trust
RECRUITING
Skien
Stavanger University Hospital
RECRUITING
Stavanger
Vestfold Hospital Trust (Hospital of Vestfold)
RECRUITING
Tønsberg
University Hospital of Northern Norway
RECRUITING
Tromsø
St. Olavs Hospital
RECRUITING
Trondheim
Sweden
Capio Saint Göran's Hospital
RECRUITING
Stockholm
Contact Information
Primary
Sven Loffeler, MD, PhD
sven.loffeler@siv.no
+4792235628
Backup
Erik S Haug, MD, PhD
erik.haug@siv.no
+4793030298
Time Frame
Start Date:2022-11-04
Estimated Completion Date:2036-12-31
Participants
Target number of participants:980
Treatments
Experimental: immediate curative therapy
Patients randomized to the intervention arm will receive immediate curative therapy in the form of either radiotherapy to the prostate in combination with hormone therapy (ADT or monotherapy) or surgery (radical prostatectomy). Standard treatment in this arm is radiotherapy + hormone therapy. Surgery is reserved for patients with strong preferences against radiotherapy.
Patients in this arm will either be observed (with localized high-risk prostate cancer) or receive hormone therapy (locally advanced prostate cancer; ADT or monotherapy). Further local or systemic therapy is given at doctor's discretion triggered by local or/ and systemic progression.