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

Not Applicable
Terminated
Conditions
Prostate Cancer
Interventions
Device: MRI scan
Registration Number
NCT00851682
Lead Sponsor
Washington University School of Medicine
Brief Summary

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

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.

Recruitment & Eligibility

Status
TERMINATED
Sex
Male
Target Recruitment
65
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
FACTORIAL
Arm && Interventions
GroupInterventionDescription
Brachytherapy patientsMRI scanPatients who have been diagnosed with prostate cancer and are scheduled to undergo brachytherapy and have not received any preoperative treatment for prostate cancer.
Radical prostatectomy patientsMRI scanPatients who have been diagnosed with prostate cancer and are scheduled to undergo radical prostatectomy and have not received any preoperative treatment for prostate cancer.
Primary Outcome Measures
NameTimeMethod
Improved Accuracy of Prostate Cancer Detection by MRI Scan.At time of treatment

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.

Secondary Outcome Measures
NameTimeMethod
Successful MRI Guidance of Transrectal Ultrasound Biopsy in Patients.At time of treatment

Ultrasound guidance of transrectal ultrasound biopsy was not attempted.

Trial Locations

Locations (1)

Washington University School of Medicine

🇺🇸

Saint Louis, Missouri, United States

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