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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 40
Maximum Age: 85
Healthy Volunteers: t
View:

• Patients who indicated MRI of pelvis due to clinical suspicion of prostate cancer based on elevated PSA (4\

⁃ 20 ng/mL), abnormal digital rectal examination or lower urinary tract syndromes.

• Males aged between 40 and 85 years with a life expectancy greater than two years.

• Naïve to prostate biopsy in the past.

• Assessment of daily physical status graded 0 to 2 based on the Eastern Cooperative Oncology Group (ECOG) criteria.

• Willing to sign the informed consent.

Locations
Other Locations
Taiwan
Chang Gung Memorial Hospital ,Linkou
RECRUITING
Taoyuan
Contact Information
Primary
Jing-Ren Tseng, MD
drTsengJR@gmail.com
+886-975361314
Time Frame
Start Date: 2024-07-01
Estimated Completion Date: 2027-05-31
Participants
Target number of participants: 71
Treatments
Experimental
Related Therapeutic Areas
Sponsors
Leads: Chang Gung Memorial Hospital
Collaborators: National Science and Technology Council

This content was sourced from clinicaltrials.gov