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NCT07533344

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

Sponsor: Fatih Sultan Mehmet Training and Research Hospital

View on ClinicalTrials.gov

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.

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

Key Details

Gender

MALE

Age Range

40 Years - Any

Study Type

OBSERVATIONAL

Enrollment

60

Start Date

2025-08-01

Completion Date

2026-02-01

Last Updated

2026-04-16

Healthy Volunteers

No

Conditions

Locations (1)

Fatih Sultan Mehmet Training and Research Hospital

Istanbul, Istanbul, Turkey (Türkiye)