Feasibility Study of Prostate Tumor Localization for Focal Cryoablation of Prostate Carcinoma

Study Overview
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Brief Summary
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The purpose of the present study is to find out if MRI techniques examining (1) the motion of water molecules in the prostate (diffusion sensitive MRI), (2) the difference in blood flow to the prostate (dynamic contrast enhanced MRI), and (3) differences in chemical composition of the prostate (MR spectroscopy), can be used to detect prostate cancer early and non-invasively. Localization of the cancer within the prostate would be of particular importance in focal cryoablation of prostate carcinoma which we hope to improve as a result of this project. Additional aim of the study is to correlate expression of genes believed to pay a role in prostate cancer with MRI findings.

Detailed Description
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Radical prostatectomy patients will undergo an MRI prior to their scheduled surgery. Ex vivo imaging will be done on prostates once removed. Results from the final pathology with be compared with results of imaging to determine the accuracy of the image analysis in cancer localization and staging. Brachytherapy patients will undergo an MRI prior to their scheduled procedure. Two areas of suspected cancer and two areas without suspected cancer will be prospectively identified based on the MRI imaging. At the time of brachytherapy, transrectal needle biopsies will be obtained from the previously identified areas. The needle cores will be reviewed by study pathologist to determine the accuracy of the image analysis in cancer localization and staging.

Official Title
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Feasibility Study of Prostate Tumor Localization for Focal Cryoablation of Prostate Carcinoma

Conditions
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Prostate Cancer

Intervention / Treatment
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* Device: MRI scan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients who have been diagnosed with prostate cancer and are scheduled for radical prostatectomy or for brachytherapy patients who have not received any preoperative treatment for their diagnosis of prostate cancer Exclusion Criteria: patients with implants that are electronically, magnetically, or mechanically active patients with intracranial aneurysm clips patients who have undergone cosmetic eyelid surgery patients with history of pheochromocytoma, insulinoma and acute glaucoma patients with estimated glomerular filtration rate (eGFR) less than 60 ml/min/1.73m2

Ages Eligible for Study
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Minimum Age: 20 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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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Radical prostatectomy patients<br>Patients who have been diagnosed with prostate cancer and are scheduled to undergo radical prostatectomy and have not received any preoperative treatment for prostate cancer. | Device: MRI scan<br>* Each patient will undergo one, contrast-enhanced MRI scan prior to his planned, standard of care procedure, either radical prostatectomy or brachytherapy, depending on the study arm. Patients will be randomized to be imaged with either a phased array body coil or an endorectal coil.<br>|
| Other: Brachytherapy patients<br>Patients who have been diagnosed with prostate cancer and are scheduled to undergo brachytherapy and have not received any preoperative treatment for prostate cancer. | Device: MRI scan<br>* Each patient will undergo one, contrast-enhanced MRI scan prior to his planned, standard of care procedure, either radical prostatectomy or brachytherapy, depending on the study arm. Patients will be randomized to be imaged with either a phased array body coil or an endorectal coil.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved Accuracy of Prostate Cancer Detection by MRI Scan. | Data obtained as part of this study could not be analyzed in a meaningful way due to problems with correlation between the cancerous tissue identified by histology and tissue imaging from imaging. | At time of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful MRI Guidance of Transrectal Ultrasound Biopsy in Patients. | Ultrasound guidance of transrectal ultrasound biopsy was not attempted. | At time of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate Cancer, Dynamic Contrast Enhanced MRI, Non-invasive Prostate Cancer Detection