Molecular PET/MR Imaging in Vivo Validation of Biomarker for Human Prostate Cancer

Study Overview
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Brief Summary
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Primary objective: To correlate the blood/urine metabolomic biomarkers with PET/MR imaging. Secondary objectives: To evaluate the sensitivity and specificity of the PET/MR in diagnosis of prostate cancer. To examine the diagnostic performance among subgroups of defined high-risk and low-risk subjects. To interrogate the metabolomic alterations with the molecular PET/MR to develop workable panel biomarkers.

Detailed Description
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According to 2015 National Comprehensive Cancer Network (NCCN) guideline, medical imaging plays important roles for detection and staging for PCa, in addition to blood or urine biomarkers. Although there are a number of very different diagnostic imaging methods, e.g. transrectal ultrasound (TRUS), computed tomography (CT), magnetic resonance (MR) imaging and spectroscopy, or 18F-FDG positron emission tomography (PET), none of these have gained a dominant role as the optimum method for all clinical scenarios.The recently added armamentarium, PET/MR, might improve diagnosis in this regard. Therefore, we conduct this trial to identify the ability of [11C]Choline PET/MR to evaluate the patients with prostate cancer, especially under the circumstance of elevated PSA level.

Official Title
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Molecular PET/MR Imaging in Vivo Validation of Biomarker for Human Prostate Cancer

Conditions
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Prostate Adenocarcinoma

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males 40-85 years of age Patients with a biopsy-proven or clinically highly suspected prostate adenocarcinoma, or benign prostatic hyperplasia Able to tolerate [11C]Choline PET scan and MRI scan Written informed consent from the patient Exclusion Criteria: Acute prostatitis or non-urologic bacterial infection requiring medical treatment within the last 3 months. History of AIDS in the period prior to the screening.3 Contraindications to [11C]Choline PET/MR scans Surgical implants including pacemaker implants, cochlear implants, dentures held in place by magnets imbedded in the gums and aneurysm clips except those inserted at CGMH Metallic prosthesis of the hip or pelvic region Renal function impairment with estimated glomerular filtration rate (eGFR) < 30 ml/min/1.73 m2 Claustrophobia Medical drugs with choline Previous allergy to carbon-labeled radionuclide Active other malignancy within the last 2 years Subject which in the opinion of the investigator preclude participation for scientific reasons, for reasons of compliance, or for reasons of the subject's safety. Prisoners or patients with mental illness

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| prostate cancer<br>The newly diagnostic number for the high-risk PCa patients in our hospital annually is  70, it is clinically feasible to recruit 40 patients a year since the study begins. The study could be completed in 3 years with 120 cases. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic Accuracy | sensitivity, specificity, accuracy | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate cancer, metabolomics, molecular imaging, PET, MRI, 11C-choline tracer