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

Launched by CHANG GUNG MEMORIAL HOSPITAL · Jul 2, 2024

Keywords

ClinConnect Summary

This clinical trial is looking to see if a special type of scan called Ga-68 PSMA PET/MRI can help doctors diagnose prostate cancer better than a standard scan known as mpMRI. The study involves men aged 40 to 85 who have signs of prostate cancer, such as a high PSA level (a blood test that can indicate prostate issues) or problems with urination. Researchers want to find out if the new scan can give more accurate results and if the location of any cancerous areas seen on the scans affects the accuracy of the diagnosis.

Eligible participants will have the Ga-68 PSMA PET/MRI scan, followed by regular check-ups every six months for two years to monitor their health and check if prostate cancer develops. To join the study, men must not have had a prostate biopsy before, must be able to tolerate the scan, and should have a life expectancy of at least two years. The trial is currently recruiting participants, and those interested will need to agree to take part and provide informed consent.

Gender

MALE

Eligibility criteria

• 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