Back to resultsFeasibility Study of Prostate Tumor Localization for Focal Cryoablation of Prostate Carcinoma
Primary Purpose
Prostate Cancer
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MRI scan
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer focused on measuring Prostate Cancer, Dynamic Contrast Enhanced MRI, Non-invasive Prostate Cancer Detection
Eligibility 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
Sites / Locations
- Washington University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Radical prostatectomy patients
Brachytherapy patients
Arm Description
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.
Patients who have been diagnosed with prostate cancer and are scheduled to undergo brachytherapy and have not received any preoperative treatment for prostate cancer.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Successful MRI Guidance of Transrectal Ultrasound Biopsy in Patients.
Ultrasound guidance of transrectal ultrasound biopsy was not attempted.
Full Information
NCT ID
NCT00851682
First Posted
February 25, 2009
Last Updated
October 5, 2018
Sponsor
Washington University School of Medicine
Collaborators
Midwest Stone Institute.
1. Study Identification
Unique Protocol Identification Number
NCT00851682
Brief Title
Feasibility Study of Prostate Tumor Localization for Focal Cryoablation of Prostate Carcinoma
Official Title
Feasibility Study of Prostate Tumor Localization for Focal Cryoablation of Prostate Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Terminated
Why Stopped
Enrollment was stopped and will not resume. Participants are no longer being examined.
Study Start Date
January 2009 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
Midwest Stone Institute.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate Cancer, Dynamic Contrast Enhanced MRI, Non-invasive Prostate Cancer Detection
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Radical prostatectomy patients
Arm Type
Other
Arm Description
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.
Arm Title
Brachytherapy patients
Arm Type
Other
Arm Description
Patients who have been diagnosed with prostate cancer and are scheduled to undergo brachytherapy and have not received any preoperative treatment for prostate cancer.
Intervention Type
Device
Intervention Name(s)
MRI scan
Intervention Description
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.
Primary Outcome Measure Information:
Title
Improved Accuracy of Prostate Cancer Detection by MRI Scan.
Description
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.
Time Frame
At time of treatment
Secondary Outcome Measure Information:
Title
Successful MRI Guidance of Transrectal Ultrasound Biopsy in Patients.
Description
Ultrasound guidance of transrectal ultrasound biopsy was not attempted.
Time Frame
At time of treatment
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert L Grubb, III, M.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Feasibility Study of Prostate Tumor Localization for Focal Cryoablation of Prostate Carcinoma
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