Ga-68 PSMA PET/CT vs mpMRI in Cognitive Prostate Biopsy

NCT07533344 | Completed

• 1 other identifier: FSMTRHURO
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

Prostate biopsy; Ga-68 PSMA PET/CT; Multiparametric MRI; Cognitive biopsy

Outcome Measures

Primary Outcomes (1)

• Clinically Significant Prostate Cancer Detection Rate

  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 Outcomes (1)

• Superiority of Ga-68 PSMA PET/CT-guided cognitive biopsy over mpMRI-guided biopsy in detecting prostate cance

  Periprocedural (at the time of prostate biopsy)

Study Arms (2)

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.

Eligibility Criteria

• Age: 40 Years+
• Gender Eligibility Details: Only male participants are eligible because the prostate gland is present only in males.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fatih Sultan Mehmet Training and Research Hospital: lead

Study Sites (1)

Fatih Sultan Mehmet Training and Research Hospital

Istanbul, Istanbul, 34752, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Serkan Akan, MD

  Fatih Sultan Mehmet Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 16, 2026
• Study Start: August 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)