68Ga-PSMA-11 PET Imaging for Diagnosing Prostate Cancer, a Head-to-head Comparison With mpMRI
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 68Ga-PSMA-11.
- Who it may be relevant to
- Registry conditions: Prostate Cancer (Adenocarcinoma). Basic parameters: 18 years — 80 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
68Ga-PSMA-11 PET Imaging in the Diagnostic Study of Newly Diagnosed, Untreated Prostate Cancer, With a Head-to-head Comparison to mpMRI
Overview
68Ga-PSMA-11 is a widely used radiotracer targeting PSMA. In this study, we investigated the diagnostic efficacy of 68Ga-PSMA-11 PET imaging (PET/CT or PET/MRI) in patients with newly diagnosed, treatment-naive prostate cancer, and performed a head-to-head comparison with multi-parameter magnetic resonance imaging (mpMRI).
Detailed description
68Ga-PSMA-11 is a radiotracer targeting PSMA. Previously, multiple clinical trials have validated the clinical applications of 68Ga-PSMA-11 PET. Meanwhile, multi-parametric magnetic resonance imaging (mpMRI) still holds a dominant position in the imaging diagnosis of prostate cancer. In this study, we will further evaluate the diagnostic performance of 68Ga-PSMA-11 positron emission tomography (PET/CT or PET/MRI) in newly diagnosed and untreated prostate cancer patients, with a head-to-head comparison to mpMRI.
Interventions
- Drug 68Ga-PSMA-11
Intravenous injection of 68Ga-PSMA-11 with a dosage of 111-148 MBq (3-4 mCi), followed by PET/CT or PET/MRI acquisition according to standard methods.
Primary outcome measures
- Sensitivity of 68Ga-PSMA-11 Imaging to Detect Intraprostatic Tumors Relative to Histopathology in newly diagnosed, treatment-naive Prostate Cacner Participants [Time frame: Within 28 days of imaging, radical prostatectomy will occur.]
- Specificity of 68Ga-PSMA-11 PET Imaging to Detect Intraprostatic Tumors Relative to Histopathology in newly diagnosed, treatment-naive Prostate Cacner Participants [Time frame: Within 28 days of imaging, radical prostatectomy will occur.]
Secondary outcome measures (1)
- Comparison of Detection Rates for Intraprostatic Tumors Between 68Ga-PSMA-11 PET Imaging and mpMRI [Time frame: Within 1-2 hours of 68Ga-PSMA-11 dosing, a whole body PET scan will be taken]
Eligibility criteria
Inclusion criteria
- Biopsy-confirmed adenocarcinoma of the prostate.
- No anti-tumor treatment received prior to the PET imaging.
- Subjects provide signed informed consent and confirm that they are able and willing to comply with all protocol requirements.
- Radical prostatectomy scheduled within 28 days after PET imaging
Exclusion criteria
- Patients with other malignant tumors
- Subjects with any medical condition or other circumstance that, in the opinion of the investigator, compromise obtaining reliable data, achieving study objectives, or completion.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
China · 1 center
- Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University — Fuzhou
Identifiers
NCT: NCT07209878 · FirstAHFujian-68Ga-PSMA-11