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New study aims to cut unnecessary prostate biopsies with smart monitoring

NCT ID NCT07180381

Diagnosis Sponsor: St. Antonius Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests a new strategy for diagnosing prostate cancer in men with moderate risk. Instead of immediately doing a biopsy, doctors will monitor them with regular PSA tests and MRI scans. The goal is to see if this approach can safely delay biopsies, avoid unnecessary procedures, and reduce overdiagnosis of slow-growing cancers that don't need treatment.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 503 people

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

Started

May 2025

Expected to finish

Jan 2031

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

18 years and older

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: * Life expectancy \> 10 years * initial PSA \< 20 ng/ml * No signs of extracapsular disease on digital rectal examination * Intermediate-risk category for suspicion of prostate cancer determined by MRI results and PSA density (PSAD): PI-RADS 3 or PI-RADS 4 with PSAD =\< 0.15 * Mentally competent and able to comprehend the potential benefits and burdens of the study * Willing to undergo the follow-up protocol for a maximum of four years * written and signed informed consent Exclusion Criteria: * Men who have previously undergone a prostate biopsy * Men who have a prior PCa diagnosis * using any (anti-)hormonal therapy, including 5-alpha-reductase inhibitors * Proven germline mutation for PCa (for example: BRCA1; BRCA2) * Secondary malignancy, besides basal cell carcinoma of the skin, for which the potential participant is receiving active treatment at the time of inclusion. * severe claustrofobia or other conditions that make (repeat) MRI unsuitable (e.g., metal implants, pacemakers)

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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

    7 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

  • Andros Clinics

    RECRUITING

    Arnhem, Gelderland, 6842 CV, Netherlands

  • Antoni van Leeuwenhoek Hospital

    RECRUITING

    Amsterdam, North Holland, Netherlands

  • Canisius Wilhelmina Hospital

    RECRUITING

    Nijmegen, Gelderland, Netherlands

  • Maasstad Hospital

    NOT_YET_RECRUITING

    Rotterdam, South Holland, Netherlands

  • Radboud University Medical Centre

    RECRUITING

    Nijmegen, Gelderland, 6525 GA, Netherlands

  • St Antonius Hospital

    RECRUITING

    Nieuwegein, Utrecht, 3435 CM, Netherlands

  • Treant

    RECRUITING

    Emmen, Drenthe, 7824AA, Netherlands

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