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Study identifier: NCT05448547 Synced from ClinicalTrials.gov · August 09, 2026
● Study status: RecruitingGrandP/SPCG19

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

Condition: Prostate Cancer  ·  Sponsor: Sven Löffeler

PhasePhase 3
Planned participants980
Who can joinMale, 75 Years to no upper limit
Healthy volunteersYesCheck eligibility criteria ↓
Where18 locations · 4 countries

Interested? Contact the study team ↓

For sponsors, CROs & site teams
Professional view of this study — listed sites, countries and recruiting context from the public registry. Everything below is written for patients and caregivers.See where this study is running →

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Sven Loffeler, MD, PhD  ·  +4792235628  ·  sven.loffeler@siv.no

Erik S Haug, MD, PhD  ·  +4793030298  ·  erik.haug@siv.no

There is no obligation to join — the study team can answer your questions about taking part.

Always discuss trial participation with your own doctor first.

Full eligibility criteria (exactly as the study team wrote them)

Inclusion Criteria: 1. Participant must be 75 years of age or older, at the time of signing the informed consent. 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: Medical Conditions 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)

Reproduced word-for-word from the public registry record — the study team can answer questions about it.

Locations (18)

RigshospitalCopenhagen, DenmarkRecruiting
Esbjerg and Grindsted HospitalEsbjerg, DenmarkRecruiting
Odense University HospitalOdense, DenmarkRecruiting
Helsinki University HospitalHelsinki, FinlandRecruiting
Tampere University HospitalTampere, FinlandRecruiting
Turku University HospitalTurku, FinlandRecruiting
Sunmøre Hospital TrustÅlesund, Møre og Romsdal, NorwayRecruiting
Oslo University HospitalOslo, Oslo, NorwayRecruiting
Stavanger University HospitalStavanger, Rogaland, NorwayRecruiting
Sørlandet Hospital TrustKristiansand, Sørlandet, NorwayRecruiting
Telemark Hospital TrustSkien, Telemark, NorwayRecruiting
St. Olavs HospitalTrondheim, Trøndelag, NorwayRecruiting

+ 6 more locations — full list on the registry record.

More studies in these areas

This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.

CopenhagenEsbjergOdenseHelsinki

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