Immediate Curative vs Conservative Treatment in Older Men With M0, High-risk Prostate Cancer
NCT ID: NCT05448547
Last Updated: 2025-07-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
980 participants
INTERVENTIONAL
2022-11-04
2036-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Radiotherapy or surgery
see arm/ group description
initial observation/ hormone therapy
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.
initial observation
see arm/ group description
Hormone therapy
androgen depression therapy (ADT) by either LHRH agonist or antagonist or androgen monotherapy
Interventions
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Radiotherapy or surgery
see arm/ group description
initial observation
see arm/ group description
Hormone therapy
androgen depression therapy (ADT) by either LHRH agonist or antagonist or androgen monotherapy
Eligibility Criteria
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Inclusion Criteria
2. 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)
3. Male
4. 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 Criteria
1. Dementia (unable to consent) Prior/Concomitant Therapy
2. Prior radiation to the pelvis
3. Hormone therapy \>3 months prior to randomization Diagnostic assessments
4. 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).
5. 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
6. Disabled or severe comorbidity (identified by G8 screening)
7. Unable to read, understand or fill out HRQoL questionnaires (PROMS)
75 Years
MALE
Yes
Sponsors
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Oslo University Hospital
OTHER
Klinbeforsk
OTHER
Sven Löffeler
OTHER
Responsible Party
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Sven Löffeler
Principal investigator
Principal Investigators
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Sven Loffeler, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
The Hospital of Vestfold
Locations
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Rigshospital
Copenhagen, , Denmark
Esbjerg and Grindsted Hospital
Esbjerg, , Denmark
Odense University Hospital
Odense, , Denmark
Helsinki University Hospital
Helsinki, , Finland
Tampere University Hospital
Tampere, , Finland
Turku University Hospital
Turku, , Finland
Sunmøre Hospital Trust
Ålesund, Møre og Romsdal, Norway
Oslo University Hospital
Oslo, Oslo County, Norway
Stavanger University Hospital
Stavanger, Rogaland, Norway
Sørlandet Hospital Trust
Kristiansand, Sørlandet, Norway
Telemark Hospital Trust
Skien, Telemark, Norway
St. Olavs Hospital
Trondheim, Trøndelag, Norway
Vestfold Hospital Trust (Hospital of Vestfold)
Tønsberg, Vestfold, Norway
Vestre Viken Hospital Trust
Drammen, , Norway
Innlandet Hospital Trust
Hamar, , Norway
Akerhus University Hospital
Lørenskog, , Norway
University Hospital of Northern Norway
Tromsø, , Norway
Capio Saint Göran's Hospital
Stockholm, , Sweden
Countries
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Central Contacts
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Facility Contacts
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Antti Rannikko, Professor, MD, PhD
Role: primary
References
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Loffeler S, Bertilsson H, Muller C, Aas K, Haugnes HS, Aksnessaether B, Pesonen M, Thon K, Tandstad T, Murtola T, Poulsen MH, Nordstrom T, Vigmostad MN, Ottosson F, Holmsten K, Christiansen O, Slaaen M, Haug ES, Storas AH, Asphaug L, Rannikko A, Brasso K; Scandinavian Prostate Cancer Group (SPCG) and the Norwegian Get-Randomized (GRand) Initiative. Protocol of a randomised, controlled trial comparing immediate curative therapy with conservative treatment in men aged >/=75 years with non-metastatic high-risk prostate cancer (SPCG 19/GRand-P). BJU Int. 2024 Jun;133(6):680-689. doi: 10.1111/bju.16314. Epub 2024 Mar 12.
Other Identifiers
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GrandP
Identifier Type: -
Identifier Source: org_study_id
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