We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been terminated.
(Enrollment was stopped and will not resume. Participants are no longer being examined.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00851682
First Posted: February 26, 2009
Last Update Posted: November 11, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Midwest Stone Institute.
Information provided by (Responsible Party):
Washington University School of Medicine
  Purpose

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.


Condition Intervention
Prostate Cancer Device: MRI scan

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Feasibility Study of Prostate Tumor Localization for Focal Cryoablation of Prostate Carcinoma

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Improved Accuracy of Prostate Cancer Detection by MRI Scan. [ Time Frame: 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:
  • Successful MRI Guidance of Transrectal Ultrasound Biopsy in Patients. [ Time Frame: At time of treatment ]
    Ultrasound guidance of transrectal ultrasound biopsy was not attempted.


Enrollment: 65
Study Start Date: January 2009
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Radical prostatectomy patients
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
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.
Brachytherapy patients
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
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.

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00851682


Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Midwest Stone Institute.
Investigators
Principal Investigator: Robert L Grubb, III, M.D. Washington University School of Medicine
  More Information

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00851682     History of Changes
Other Study ID Numbers: HRPO#03-0535
First Submitted: February 25, 2009
First Posted: February 26, 2009
Results First Submitted: September 8, 2015
Results First Posted: November 11, 2015
Last Update Posted: November 11, 2015
Last Verified: October 2015

Keywords provided by Washington University School of Medicine:
Prostate Cancer
Dynamic Contrast Enhanced MRI
Non-invasive Prostate Cancer Detection

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases