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

Chang Gung Medical Foundation

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Diagnostic Test: Ga-68 PSMA PET/MRI

Study type: Observational

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT06494696

202400643A3

Details and patient eligibility

About

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.

Enrollment: 71 estimated patients

Sex: Male

Ages: 40 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. 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.
2. Males aged between 40 and 85 years with a life expectancy greater than two years.
3. Naïve to prostate biopsy in the past.
4. Assessment of daily physical status graded 0 to 2 based on the Eastern Cooperative Oncology Group (ECOG) criteria.
5. Willing to sign the informed consent.

Exclusion criteria

1. Unable to tolerate the PET/MRI scan, such as those with claustrophobia, unable to lie still, consciousness unclear, vital sign unstable, or having MRI unsafe metallic implants or devices.
2. With renal impairment (glomerular filtration rate lower than 30 ml/min/1.73 m2), and allergy to medium contrast.
3. High risk to conduct examination after evaluations of PI
4. Patient had previous malignancy history

Trial design

71 participants in 1 patient group

Experimental

Treatment:

Diagnostic Test: Ga-68 PSMA PET/MRI