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Major study to settle debate: surgery or radiation for aggressive prostate cancer?

NCT ID NCT05931419

Knowledge-focused Sponsor: Comprehensive Cancer Centre The Netherlands 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study follows 837 men with high-risk prostate cancer who choose either robot-assisted surgery or radiation therapy (with or without hormone therapy). Researchers will compare quality of life, side effects, and cancer control over time. The goal is to help patients and doctors make more informed treatment decisions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could help doctors and patients choose the best treatment for high-risk prostate cancer based on quality of life and survival.
What could go wrong
This is an observational study, not a randomized trial, so results may be influenced by patient selection. It will take years to complete and may not provide definitive answers.

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.

Participants

About 837 people

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

Started

Feb 2023

Expected to finish

Jun 2030

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.

Who is studied

Patients with de novo non-metastatic high-risk prostate cancer (cT3a-bN0M0 and/or ISUP grade ≥4 and/or PSA \>20ng/ml), who have opted for treatment with RARP or EBRT +/- ADT and are diagnosed in, or are referred to one of the participating hospitals

Ages

50 to 75 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Histologically confirmed de novo non-metastatic high-risk prostate cancer. * cT3a-bN0M0, according to the 8th edition of the Tumour, Node, Metastasis (TNM) classification, with the exception that clinical T-stage will be based on digital rectal examination and magnetic resonance imaging (the highest stage will be used) and/or * International Society of Urological Pathology (ISUP) grade ≥4 and/or * Prostate-Specific Antigen (PSA) value at diagnosis greater than 20 ng/mL * Fit for treatment with either RARP or EBRT +/- ADT (WHO performance status 0-1) * Living in the Netherlands * Able to read and understand the Dutch language Exclusion Criteria: * Histological types other than adenocarcinoma * Diagnosis and/or treatment in a hospital abroad * Treatment with Androgen Receptor Targeted Agents (ARTA) as part of the initial treatment plan

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

prostate adenocarcinoma prostate cancer

As listed by the trial registrant

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

Prostate adenocarcinoma 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

    24 sites. 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

  • Admiraal de Ruyter Ziekenhuis

    RECRUITING

    Goes, Netherlands

  • Albert Schweitzer Ziekenhuis

    RECRUITING

    Dordrecht, Netherlands

  • Amsterdam UMC

    RECRUITING

    Amsterdam, Netherlands

  • Antoni van Leeuwenhoek Ziekenhuis

    RECRUITING

    Amsterdam, Netherlands

  • BovenIJ ziekenhuis

    RECRUITING

    Amsterdam, Netherlands

  • Canisius Wilhelmina Ziekenhuis

    COMPLETED

    Nijmegen, Netherlands

  • Catharina Ziekenhuis

    COMPLETED

    Eindhoven, Netherlands

  • Dijklander Ziekenhuis

    RECRUITING

    Hoorn, Netherlands

  • Erasmus Medisch Centrum Rotterdam

    RECRUITING

    Rotterdam, Netherlands

  • Franciscus Gasthuis & Vlietland

    RECRUITING

    Rotterdam, Netherlands

  • Haaglanden Medisch Centrum

    RECRUITING

    The Hague, Netherlands

  • Leids Universitair Medisch Centrum

    RECRUITING

    Leiden, Netherlands

  • Maasstad Ziekenhuis

    RECRUITING

    Rotterdam, Netherlands

  • Martini ziekenhuis

    RECRUITING

    Groningen, Netherlands

  • Maxima Medisch Centrum

    COMPLETED

    Veldhoven, Netherlands

  • Noordwest Ziekenhuisgroep

    RECRUITING

    Alkmaar, Netherlands

  • OLVG

    RECRUITING

    Amsterdam, Netherlands

  • Ommelander Ziekenhuis

    RECRUITING

    Scheemda, Netherlands

  • Radboudumc

    COMPLETED

    Nijmegen, Netherlands

  • Rode Kruis Ziekenhuis

    RECRUITING

    Beverwijk, Netherlands

  • Saxenburgh Medisch Centrum

    RECRUITING

    Hardenberg, Netherlands

  • Spaarne Gasthuis

    RECRUITING

    Hoofddorp, Netherlands

  • St Jansdal

    RECRUITING

    Harderwijk, Netherlands

  • Treant

    RECRUITING

    Hoogeveen, Netherlands

  • Universitair Medisch Centrum Groningen

    RECRUITING

    Groningen, Netherlands

  • Verbeeten Instituut

    RECRUITING

    Tilburg, Netherlands

  • Wilhelmina Ziekenhuis

    RECRUITING

    Assen, Netherlands

  • Zaans Medisch Centrum

    RECRUITING

    Zaandam, Netherlands

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