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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

NCT ID NCT05448547

NEW Sponsor: Sven Löffeler Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 10, 2026 · Last updated Sep 10, 2026

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 980 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2022

Expected to finish

Dec 2036

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

75 years and older

Sex

Male participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostate cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    26 sites in 4 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Akademiska sjukhuset, Uppsala

    RECRUITING

    Uppsala, Sweden

  • Akerhus University Hospital

    RECRUITING

    Lørenskog, 1478, Norway

  • Capio Saint Göran's Hospital

    RECRUITING

    Stockholm, 11219, Sweden

  • Esbjerg and Grindsted Hospital

    RECRUITING

    Esbjerg, Denmark

  • Falu Lasarett

    RECRUITING

    Falun, Sweden

  • Helsingborg/Ängelholm hospital

    RECRUITING

    Helsingborg, Sweden

  • Helsinki University Hospital

    RECRUITING

    Helsinki, 00029, Finland

  • Innlandet Hospital Trust

    RECRUITING

    Hamar, Norway

  • Norrlands universitetssjukhus

    RECRUITING

    Umeå, 907 37, Sweden

  • Odense University Hospital

    RECRUITING

    Odense, Denmark

  • Oslo University Hospital

    RECRUITING

    Oslo, Norway

  • Rigshospital

    RECRUITING

    Copenhagen, Denmark

  • Sahlgrenska University Hospital

    RECRUITING

    Gothenburg, 413 45, Sweden

  • St. Olavs Hospital

    RECRUITING

    Trondheim, Trøndelag, 7006, Norway

  • Stavanger University Hospital

    RECRUITING

    Stavanger, Rogaland, Norway

  • Sunmøre Hospital Trust

    RECRUITING

    Ålesund, Møre og Romsdal, Norway

  • Södersjukhuset

    RECRUITING

    Stockholm, 11883, Sweden

  • Sørlandet Hospital Trust

    RECRUITING

    Kristiansand, Sørlandet, 4604, Norway

  • Tampere University Hospital

    RECRUITING

    Tampere, Finland

  • Telemark Hospital Trust

    RECRUITING

    Skien, Telemark, 3710, Norway

  • Turku University Hospital

    RECRUITING

    Turku, 20520, Finland

  • University Hospital of Northern Norway

    RECRUITING

    Tromsø, Norway

  • Vestfold Hospital Trust (Hospital of Vestfold)

    RECRUITING

    Tønsberg, Vestfold, 3103, Norway

  • Vestre Viken Hospital Trust

    RECRUITING

    Drammen, 3004, Norway

  • Örebro University Hospital

    RECRUITING

    Örebro, Sweden

  • Östersunds Hospital

    RECRUITING

    Östersund, Sweden

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