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New scans could sharpen prostate cancer detection

NCT ID NCT07568613

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests two advanced imaging techniques, PSMA PET/CT and MRI-RSI, against the standard MRI to see which finds and outlines prostate tumors most accurately. Fifty men with newly diagnosed, higher-risk prostate cancer will undergo all scans and a targeted biopsy. The goal is to improve personalized treatment planning by reducing errors in tumor detection and measurement.

What this could mean

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

Active substance
MRI-RSI and PSMA PET/CT imaging
What this could lead to
If successful, this could lead to more accurate tumor detection and treatment planning for prostate cancer, potentially reducing the need for repeat biopsies.
What could go wrong
This is a small, early-stage study (50 participants) comparing imaging methods, not testing a treatment. Results may not apply to all patients, and the new techniques might not prove better than current MRI.

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 50 people

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

Started

Aug 2025

Expected to finish

Jul 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: * Newly diagnosed and histologically confirmed primary prostate cancer * NCCNv4.2024 risk groups: unfavorable intermediate risk, high-risk and very high-risk * Males, age ≥ 18 years * ECOG performance status 0-2 * Estimated life expectancy ≥ 5 years * PSMA-PET/CT-hybrid imaging performed \<3 months * MRI-targeted biopsy on PIRADs v2.1 lesion ≥3 performed \<6 months Exclusion Criteria: * Contraindications for MRI imaging * No visible tumor on PSMA PET and mpMRI (defined by PIRADs v2.1 ≤2 lesion) * TUR-P of the prostate \<1 year ago * Initial PSA \>100 ng/ml * History of cancer (exception: localized skin tumours, tumours treated ≥5 years previously with curative intent and no evidence of recurrent disease) * Previous radiation therapy to the pelvis * ADT or ADT + other systemic therapy before inclusion

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    1 site. 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

  • German Oncology Center

    RECRUITING

    Limassol, 4108, Cyprus

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