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New scan could help men with Low-Risk prostate cancer avoid unnecessary biopsies

NCT ID NCT07168616

Diagnosis Sponsor: Istanbul University - Cerrahpasa 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests a new way of reading PSMA PET/CT scans, called the Istanbul PSMA PET/CT Criteria, to see if it can better identify which men with low-risk prostate cancer can safely choose active surveillance (monitoring instead of immediate treatment). The researchers will enroll 201 men with low-risk prostate cancer and compare the scan results to later biopsy or surgery findings. If the criteria work well, it could help more men avoid repeat biopsies and overtreatment.

What this could mean

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

Active substance
Ga-68 PSMA11 PET/CT scan
What this could lead to
If successful, this could provide a more accurate way to decide which low-risk prostate cancer patients can safely avoid immediate treatment, reducing overtreatment and unnecessary biopsies.
What could go wrong
This is an early diagnostic study, not a treatment trial. The new criteria may not prove accurate enough in practice, and results may not apply to all patients or settings.

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 201 people

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

Started

Sep 2025

Expected to finish

Jun 2028

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

Only Turkish patients

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: * mpMRI performed within 3 months prior to enrollment * Systematic or MRI-targeted prostate biopsy performed * Biopsy-confirmed ISUP Grade 1 low-risk PCa * Prostate biopsy report specifying tumor localization and number of positive cores * Meets AS criteria: ISUP 1, PSA ≤10 ng/mL, PSAd \>0.15 ng/mL², clinical stage cT1c-T2a, ≤3 positive cores * Life expectancy ≥10 years * No prior PSMA PET imaging * No evidence of extra-prostatic disease on mpMRI * Signed informed consent for study procedures Exclusion Criteria: * High-risk or unfavorable intermediate-risk PCa, or adverse histologies (neuroendocrine, ductal adenocarcinoma, basal cell carcinoma, TP53 or BRCA1/2 mutations if available) * Prior prostate cancer treatment or prostate surgery * MRI evidence of extracapsular extension, seminal vesicle invasion, or nodal metastasis * History of pelvic radiotherapy * Life expectancy \<10 years * Severe renal impairment * Inability to comply with follow-up schedule

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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.

Clinically significant prostate cancer Low risk 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

    10 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

  • Acibadem University Altunizade Hospital

    RECRUITING

    Istanbul, 34000, Turkey (Türkiye)

  • Acibadem University Maslak Hospital

    RECRUITING

    Istanbul, 34000, Turkey (Türkiye)

  • Bilkent Şehir Hastanesi

    RECRUITING

    Ankara, Turkey (Türkiye)

  • Gazi Yaşargil Egitim ve Arastirma Hastanesi

    RECRUITING

    Diyarbakır, Turkey (Türkiye)

  • Gaziantep Üniversitesi Şahinbey Araştırma ve Uygulama hastanesi

    RECRUITING

    Gaziantep, Turkey (Türkiye)

  • Haseki Eğitim ve Araştırma Hastanesi

    RECRUITING

    Istanbul, 34000, Turkey (Türkiye)

  • Istanbul University-Cerrahpaşa

    RECRUITING

    Istanbul, 34000, Turkey (Türkiye)

  • SBÜ Başakşehir Çam Sakura Şehir hastanesi

    RECRUITING

    Istanbul, 34000, Turkey (Türkiye)

  • Sisli Hamidiye Etfal Eğitim ve Arastırma Hastanesi

    RECRUITING

    Istanbul, 34000, Turkey (Türkiye)

  • Yeditepe University

    RECRUITING

    Istanbul, Turkey, 34000, Turkey (Türkiye)

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