Actively Recruiting
68Ga-PSMA PET/MRI in Conjunction With mpMRI for Evaluating Prospective Prostate Cancer Risk
Led by Chang Gung Memorial Hospital · Updated on 2024-07-10
71
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
Sponsors
C
Chang Gung Memorial Hospital
Lead Sponsor
N
National Science and Technology Council
Collaborating Sponsor
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
68Ga-PSMA PET/MRI in Conjunction With mpMRI for Evaluating Prospective Prostate Cancer Risk
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male patients aged 40 to 85 years with life expectancy over two years
- Clinical suspicion of prostate cancer based on elevated PSA (4~20 ng/mL), abnormal digital rectal exam, or lower urinary tract symptoms
- No previous prostate biopsy
- Daily physical status graded 0 to 2 on Eastern Cooperative Oncology Group (ECOG) criteria
- Willing to sign informed consent
You will not qualify if you...
- Unable to tolerate PET/MRI scan due to claustrophobia, inability to lie still, unclear consciousness, unstable vital signs, or MRI unsafe metallic implants/devices
- Renal impairment with glomerular filtration rate below 30 ml/min/1.73 m2 or allergy to contrast medium
- High risk for examination after evaluations of PI
- History of previous malignancy
AI-Screening
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Trial Site Locations
Total: 1 location
1
Chang Gung Memorial Hospital ,Linkou
Taoyuan City, Taiwan, 333
Actively Recruiting
Research Team
J
Jing-Ren Tseng, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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