Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New scan may spare men from unnecessary prostate biopsies

NCT ID NCT05154162

Diagnosis Sponsor: Peter MacCallum Cancer Centre, Australia Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 whether adding a PSMA PET scan helps doctors better diagnose significant prostate cancer in men whose MRI results are unclear or negative. About 660 men with no prior prostate cancer or biopsy will be randomly assigned to receive either standard care or an additional PSMA PET scan. If the PSMA PET is negative, those men may avoid a biopsy, potentially reducing unnecessary procedures and their risks.

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 660 people

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

Started

Mar 2022

Expected to finish

Aug 2027

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: * Patients must meet all the following criteria for study entry: 1. Males aged ≥ 18 years at the time of consent 2. No previously diagnosed prostate cancer 3. No previous prostate biopsy 4. Having undergone MRI within 9 months prior to randomisation and meet one of the following criteria: * PI-RADS 2 AND ≥1 red flag defined as: * PSA density \>0.1 * Abnormal DRE * Strong family history (1 first degree relative or ≥2 second degree) * BRCA mutation * PSA \>10 * PSA doubling time \<36 months * PSA velocity \>0.75/year * PI-RADS 3 5. Intention for prostate biopsy 6. Willing and able to comply with all study requirements Exclusion Criteria: * Patients who meet any of the following criteria will be excluded from study entry: 1. Having a PSA \>20ng/ml 2. Having ≥ cT3 on DRE 3. Significant morbidity that, in the judgement of the investigator, would limit compliance with study protocol

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Prostate cancer are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

neoplasm prostate cancer

As listed by the trial registrant

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

Prostate cancer

Contacts and locations

Locations

  • Austin Health

    Melbourne, Victoria, 3084, Australia

  • Cabrini Health

    Melbourne, Victoria, 3144, Australia

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000, Australia

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000, Australia

  • Royal Brisbane and Women's Hospital

    Brisbane, Queensland, 4006, Australia

  • St Vincent's Hospital

    Sydney, New South Wales, 2010, Australia

More trials for these conditions

Other studies related to the condition(s) this trial covers.