Ga-68 PSMA PET/CT vs mpMRI in Cognitive Prostate Biopsy (PSMA-MRI BX)

April 14, 2026 updated by: Fatih Sultan Mehmet Training and Research Hospital

Comparison of Ga-68 PSMA PET/CT and Multiparametric Prostate MRI for Lesion Detection in Cognitive Prostate Biopsy

Prostate cancer is the most common malignancy among elderly men. With the routine use of prostate-specific antigen (PSA) testing since the 1980s, the incidence of prostate cancer has significantly increased. The diagnosis of prostate cancer is established through prostate biopsy, and several biopsy techniques have been developed in recent years.

Prostate biopsy can be broadly classified into systematic and targeted biopsy techniques. Systematic biopsy is performed under transrectal or transperineal ultrasound guidance without the use of prior imaging. Targeted biopsy techniques include cognitive biopsy, multiparametric magnetic resonance imaging (mpMRI) fusion biopsy, in-bore MRI biopsy, and robotic biopsy.

Cognitive biopsy is defined as the targeting of lesions identified on pre-biopsy imaging, usually multiparametric prostate MRI. MRI-fusion biopsy integrates mpMRI images with real-time ultrasound images, while in-bore biopsy is performed directly under MRI guidance. Although MRI-fusion biopsy is considered the gold standard technique, cognitive biopsy is more commonly used in developing countries due to lower cost and reasonable diagnostic accuracy.

Recently, Ga-68 prostate-specific membrane antigen (PSMA) PET/CT has become the gold standard imaging modality for staging prostate cancer after receiving FDA approval. PSMA is a type II transmembrane protein highly expressed on prostate cancer cells. PSMA PET/CT has high sensitivity and specificity for the detection, staging, and recurrence of prostate cancer.

Currently, multiparametric prostate MRI is commonly used to detect lesions before cognitive biopsy. However, there is no study in the literature evaluating the use of PSMA PET/CT imaging for guiding cognitive prostate biopsy.

In this retrospective single-center study, the investigators aim to compare the effectiveness of Ga-68 PSMA PET/CT and multiparametric prostate MRI as imaging modalities used prior to cognitive prostate biopsy.

Study Overview

Status

Completed

Conditions

Detailed Description

This retrospective study will include patients who underwent cognitive prostate biopsy at the Urology Department of Health Sciences University Fatih Sultan Mehmet Training and Research Hospital between 2020 and 2024.

Patient records will be reviewed retrospectively. The collected data will include:

Age PSA levels PSA density Prostate volume Prostate biopsy pathology results mpMRI PIRADS scores Ga-68 PSMA PET/CT imaging reports

Patients will be divided into two groups according to the imaging modality used prior to cognitive prostate biopsy:

Patients evaluated with multiparametric prostate MRI Patients evaluated with Ga-68 PSMA PET/CT

The diagnostic outcomes of cognitive biopsy will be compared between these two imaging modalities.

Since the study is retrospective, it will not require additional procedures, interventions, or costs for patients or the institution.

The study will be conducted at a single center.

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Istanbul
      • Istanbul, Istanbul, Turkey (Türkiye), 34752
        • Fatih Sultan Mehmet Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients aged ≥40 years who underwent cognitive prostate biopsy for suspected prostate cancer with pre-biopsy imaging using multiparametric prostate MRI or Ga-68 PSMA PET/CT between 2020 and 2024.

Description

Inclusion Criteria:

  • Male patients aged 40 years or older
  • Patients who underwent cognitive prostate biopsy between 2020 and 2024
  • Patients who had pre-biopsy imaging with multiparametric prostate MRI or Ga-68 PSMA PET/CT
  • Patients with available prostate biopsy pathology results
  • Patients with prostate lesions scored PIRADS 4 or 5 on multiparametric prostate MRI

Exclusion Criteria:

  • Patients with incomplete clinical or imaging data
  • Patients without available histopathological biopsy results
  • Patients who underwent prostate biopsy without pre-biopsy imaging
  • Patients with lesions scored PIRADS ≤3 on multiparametric prostate MRI

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
mpMRI-guided Cognitive Biopsy
Patients who underwent cognitive prostate biopsy after lesion detection with multiparametric prostate MRI.
Ga-68 PSMA PET/CT-guided Cognitive Biopsy
Patients who underwent cognitive prostate biopsy after lesion detection with Ga-68 PSMA PET/CT imaging.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinically Significant Prostate Cancer Detection Rate
Time Frame: Periprocedural (at the time of prostate biopsy)
Comparison of clinically significant prostate cancer detection rates between patients undergoing cognitive prostate biopsy guided by multiparametric prostate MRI and those guided by Ga-68 PSMA PET/CT.
Periprocedural (at the time of prostate biopsy)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Superiority of Ga-68 PSMA PET/CT-guided cognitive biopsy over mpMRI-guided biopsy in detecting prostate cance
Time Frame: Periprocedural (at the time of prostate biopsy)
Comparison of prostate cancer detection rates
Periprocedural (at the time of prostate biopsy)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fatih Sultan Mehmet Training and Research Hospital

Investigators

  • Principal Investigator: Serkan Akan, MD, Fatih Sultan Mehmet Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2025

Primary Completion (Actual)

February 1, 2026

Study Completion (Actual)

February 1, 2026

Study Registration Dates

First Submitted

April 7, 2026

First Submitted That Met QC Criteria

April 14, 2026

First Posted (Actual)

April 16, 2026

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 14, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FSMTRHURO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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