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


N/A
20 Years
85 Years
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Improved accuracy of prostate cancer detection by MRI scan.

Outcome Time Frame:

At time of treatment

Safety Issue:

No

Principal Investigator

Robert L Grubb, III, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine

Authority:

United States: Institutional Review Board

Study ID:

HRPO#03-0535

NCT ID:

NCT00851682

Start Date:

January 2009

Completion Date:

April 2014

Related Keywords:

  • Prostate Cancer
  • Prostate Cancer
  • Dynamic Contrast Enhanced MRI
  • Non-invasive Prostate Cancer Detection
  • Carcinoma
  • Prostatic Neoplasms

Name

Location
Washington University School of Medicine Saint Louis, Missouri  63110