Staging Prostate Cancer With Hybrid C11-Choline PET/MR and mpMRI

Study Overview
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Brief Summary
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The purpose of this study is to find out if a PET/MR scan in combination with standard MRI and CT scans can improve the early detection and treatment of patients with prostate cancer.

Detailed Description
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High risk prostate cancer patients will undergo C11-Choline PET/MR whole body fusion scan and pelvic mpMRI for accurate staging. The PET/MR imaging findings, including the primary lesion with the prostate bed and pelvic lymph nodes, will be correlated with the histopathologic result. Researchers aim to provide accurate one-stop shopping opportunity in diagnosis and staging of high risk prostate cancer using the C11-choline PET/MR scan.

Official Title
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Staging of Untreated Patients With Very High-risk and High-risk Prostate Carcinoma Utilizing Hybrid C11-choline PET/MR and Pelvic Multiparametric MRI for Personalized Precise Treatment: a Pilot Study

Conditions
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Prostate Adenocarcinoma

Intervention / Treatment
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* Drug: C-11 choline PET tracer
* Drug: Gadobutrol
* Device: PET/MR scanner


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Untreated patients with high-risk and very high-risk prostate cancer, who require clinical pelvic mpMRI, CT, and bone scan as standard clinical care for diagnosis and management of prostate cancer. Exclusion Criteria: Patients who already received primary treatment or neo-adjuvant therapy. Patients who refuse undergoing routine clinical imaging (i.e., pelvic mpMRI, CT, bone scan) for staging. Reimbursement of pelvic mpMRI in this study is denied. CT and bone scan may be done elsewhere outside of Mayo Clinic but should be of diagnostic quality. Research C-11 choline PET/MR will not substitute pelvic mpMRI, CT, or bone scan in this study. Patients cannot tolerate MRI (e.g., claustrophobia, severe back pain or spasm, involuntary movement [e.g., tremor, dystonia]). Patients have total hip arthroplasty (THA), which can cause substantial susceptibility artifact and degrade image quality of mpMRI. Patients have cardiac pacemaker, cochlear implants, neurostimulator, medical device which is unsafe at 3 Tesla, or foreign metallic body in the eyes or orbit. Patients have contraindication to gadolinium based MR contrast agents (e.g., renal failure, severe reaction to gadolinium based MR contrast agents). Epidermal growth factor receptor (eGFR) should be above 30 within 30 days the time of mpMRI.

Ages Eligible for Study
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Minimum Age: 18 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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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Risk Prostate Cancer Patients<br>Subjects will receive C-11 choline PET Tracer and Gadobutrol prior to the one time Positron emission tomography (PET/MR scanner) imaging and Multiparametric Magnetic resonance imaging (mpMRI). | Drug: C-11 choline PET tracer<br>* C-11 choline PET tracer, One dose, totally 12-14 millicurie (mCi), intravenous administration while patient is lying on the table.<br>* Other names: Choline C-11 Injection;Drug: Gadobutrol<br>* Single dose of Gadavist® (Gadobutrol, Bayer) at no more than 0.1 mmol/kg will be administrated intravenously.<br>* Other names: Gadavist;Device: PET/MR scanner<br>* C11-PET/MR and pelvic mpMRI scan for prostate cancer.<br>* Other names: GE SIGNA 3T PET/MR scanner;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uptake Value of C11-choline | Measured by maximum standardized uptake value (SUVmax) of indexed lesions. SUV is calculated as ratio of concentration of tissue reactivity divided by dose at time of injection divided by body weight. | Baseline | 
| Number of Lesions Showing C11-Choline Uptake | Measured by the mean number of lesions to show C11-Choline uptake. | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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high risk, prostate cancer, C11-choline, PET/MR, mpMRI