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

Recruiting now

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT06494696

Run by

Chang Gung Memorial Hospital

People needed

71

Starts

2024-07-01

Expected to finish

2027-05-31

Last updated by the study team

2024-07-10

Who can join

Age: 40 and older, up to 85. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• With renal impairment (glomerular filtration rate lower than 30 ml/min/1.73 m2), and allergy to medium contrast.
• High risk to conduct examination after evaluations of PI
• Patient had previous malignancy history

Where it is running

• Chang Gung Memorial Hospital ,Linkou — Taoyuan City, Taiwan (enrolling)

Full record on ClinicalTrials.gov

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