Actively Recruiting
68Ga-PSMA-11 PET Imaging in Newly Diagnosed, Untreated Prostate Cancer Compared to Multi-Parametric MRI
Led by First Affiliated Hospital of Fujian Medical University · Updated on 2025-10-07
100
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the diagnostic effectiveness of 68Ga-PSMA-11 PET imaging compared to multi-parametric magnetic resonance imaging (mpMRI) in men with newly diagnosed, untreated prostate cancer. This study aims to further assess how well 68Ga-PSMA-11 PET (using PET/CT or PET/MRI) detects prostate tumors in this patient group. The trial is supported by the First Affiliated Hospital of Fujian Medical University and builds upon prior clinical trials validating 68Ga-PSMA-11 PET applications. Participants receive an intravenous injection of 68Ga-PSMA-11 at a dose of 111-148 MBq (3-4 mCi), followed by PET/CT or PET/MRI scans using standard imaging methods. The study directly compares the detection rates and diagnostic performance of 68Ga-PSMA-11 PET imaging with mpMRI. Radical prostatectomy surgery is scheduled within 28 days after imaging to confirm tumor presence through histopathology. During the study, researchers measure the sensitivity and specificity of 68Ga-PSMA-11 PET in identifying intraprostatic tumors relative to surgical pathology results. Additional assessments compare tumor detection rates between the PET imaging and mpMRI. Participants undergo a whole-body PET scan within 1-2 hours after tracer injection. The trial lasts from screening through imaging and surgery, with data collected to evaluate the diagnostic accuracy of these imaging methods in prostate cancer.
CONDITIONS
Brief Title
68Ga-PSMA-11 PET Imaging for Diagnosing Prostate Cancer, a Head-to-head Comparison With mpMRI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Biopsy-confirmed adenocarcinoma of the prostate
- No anti-tumor treatment received before PET imaging
- Signed informed consent and ability to comply with study requirements
- Radical prostatectomy scheduled within 28 days after PET imaging
You will not qualify if you...
- Presence of other malignant tumors
- Any medical condition or circumstance that may interfere with reliable data collection or study completion, as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Within 1 to 2 hours on the day of imaging
Participants receive an intravenous injection of 68Ga-PSMA-11 followed by PET/CT or PET/MRI imaging to evaluate prostate cancer.
1 visit (in-person)
Duration - Up to 28 days after imaging
Participants undergo radical prostatectomy within 28 days after imaging to confirm diagnostic results.
1 visit (in-person) for surgery
Trial Site Locations
Total: 1 location
1
Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China, 350005
Actively Recruiting
Research Team
W
Weibing Miao, MD
G
Guochang Wang, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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