Actively Recruiting
Immediate Curative vs Conservative Treatment in Older Men With M0, High-risk Prostate Cancer
Led by Sven Löffeler · Updated on 2025-07-01
980
Participants Needed
18
Research Sites
738 weeks
Total Duration
On this page
Sponsors
S
Sven Löffeler
Lead Sponsor
O
Oslo University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Immediate Curative vs Conservative Treatment in Older Men With M0, High-risk Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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)
- Diagnosed with prostate cancer within 6 months with one or both of the following: Gleason grade 8-10 (ISUP group 4 and 5) with tumor palpable or visible on MRI (PIRADS 4 or 5), or locally advanced prostate cancer (T3 or T4) confirmed by clinical or radiological exam
- Able to read, understand and fill in health-related quality of life questionnaires
- Male
- Capable of giving signed informed consent and complying with study requirements
You will not qualify if you...
- Dementia or unable to consent
- Prior radiation to the pelvis
- Hormone therapy for more than 3 months before randomization
- Lymph node metastasis (N1) on MRI, CT or PSMA-PET CT
- Distant metastasis (M1) on MRI, CT, bone scan or PSMA-PET CT
- Disabled or severe comorbidity identified by G8 screening
- Unable to read, understand or fill out health-related quality of life questionnaires
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 18 locations
1
Rigshospital
Copenhagen, Denmark
Actively Recruiting
2
Esbjerg and Grindsted Hospital
Esbjerg, Denmark
Actively Recruiting
3
Odense University Hospital
Odense, Denmark
Actively Recruiting
4
Helsinki University Hospital
Helsinki, Finland, 00029
Actively Recruiting
5
Tampere University Hospital
Tampere, Finland
Actively Recruiting
6
Turku University Hospital
Turku, Finland, 20520
Actively Recruiting
7
Sunmøre Hospital Trust
Ålesund, Møre og Romsdal, Norway
Actively Recruiting
8
Oslo University Hospital
Oslo, Oslo, Norway
Actively Recruiting
9
Stavanger University Hospital
Stavanger, Rogaland, Norway
Actively Recruiting
10
Sørlandet Hospital Trust
Kristiansand, Sørlandet, Norway, 4604
Actively Recruiting
11
Telemark Hospital Trust
Skien, Telemark, Norway, 3710
Actively Recruiting
12
St. Olavs Hospital
Trondheim, Trøndelag, Norway, 7006
Actively Recruiting
13
Vestfold Hospital Trust (Hospital of Vestfold)
Tønsberg, Vestfold, Norway, 3103
Actively Recruiting
14
Vestre Viken Hospital Trust
Drammen, Norway, 3004
Actively Recruiting
15
Innlandet Hospital Trust
Hamar, Norway
Actively Recruiting
16
Akerhus University Hospital
Lørenskog, Norway, 1478
Actively Recruiting
17
University Hospital of Northern Norway
Tromsø, Norway
Actively Recruiting
18
Capio Saint Göran's Hospital
Stockholm, Sweden, 11219
Actively Recruiting
Research Team
S
Sven Loffeler, MD, PhD
CONTACT
E
Erik S Haug, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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