NCT06494696

68Ga-PSMA PET/MRI in Conjunction With mpMRI for Evaluating Prospective Prostate Cancer Risk

Utilizing 68Ga-PSMA PET/MRI Imaging in Conjunction With mpMRI for Evaluating Prospective Prostate Cancer Risk

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 71 (estimated)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: Male
• Age: 40 Years – 85 Years
• Healthy volunteers: Accepted

Summary

The goal of this observational study is to learn if Ga-68 PSMA PET/MRI can better diagnose prostate cancer than mpMRI in males between 40 to 85 years old who is naive to prostate biopsy and is suspicious for prostate cancer by elevated PSA or lower urinary tract symptoms. The main questions it aims to answer are: 1. Does PSMA PET/MRI have better PPV and NPV than mpMRI to diagnose prostate cancer? 2. Does lesion location concordance in PSMA PET and MRI effect diagnosis accuracy? Participants will: 1. Undergo a Ga-68 PSMA PET/MRI scan and keep followed up for 2 years to check if prostate cancer is diagnosed after the scan. 2. Between the follow-up period, visit the clinic once every 6 months for checkups and blood tests.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Ga-68 PSMA PET/MRI	The participant will undergo a Ga-68 PSMA PET/MRI scan, and then be followed up for 2 years to see if prostate cancer is diagnosed.

Timeline

• Start date: 2024-07-01
• Primary completion: 2027-05-31
• Completion: 2027-05-31
• First posted: 2024-07-10
• Last updated: 2024-07-10

Locations

1 site across 1 country: Taiwan