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

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ClinicalTrials.gov Identifier: NCT00851682
Recruitment Status : Terminated (Enrollment was stopped and will not resume. Participants are no longer being examined.)
First Posted : February 26, 2009
Results First Posted : November 11, 2015
Last Update Posted : October 31, 2018
Sponsor:
Collaborator:
Midwest Stone Institute.
Information provided by (Responsible Party):
Washington University School of Medicine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Prostate Cancer
Intervention Device: MRI scan
Enrollment 65
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Radical Prostatectomy Patients Brachytherapy Patients
Hide Arm/Group 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.

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.

Patients who have been diagnosed with prostate cancer and are scheduled to undergo brachytherapy and have not received any preoperative treatment for prostate cancer.

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.

Period Title: Overall Study
Started 60 5
Completed 55 5
Not Completed 5 0
Reason Not Completed
screen failure             5             0
Arm/Group Title Radical Prostatectomy Patients Brachytherapy Patients Total
Hide Arm/Group 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.

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.

Patients who have been diagnosed with prostate cancer and are scheduled to undergo brachytherapy and have not received any preoperative treatment for prostate cancer.

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.

Total of all reporting groups
Overall Number of Baseline Participants 60 5 65
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 5 participants 65 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
41
  68.3%
2
  40.0%
43
  66.2%
>=65 years
19
  31.7%
3
  60.0%
22
  33.8%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 60 participants 5 participants 65 participants
60
(39 to 76)
66
(58 to 73)
61
(39 to 76)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 5 participants 65 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
60
 100.0%
5
 100.0%
65
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 60 participants 5 participants 65 participants
60 5 65
1.Primary Outcome
Title Improved Accuracy of Prostate Cancer Detection by MRI Scan.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population 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.
Arm/Group Title Radical Prostatectomy Patients Brachytherapy Patients
Hide Arm/Group 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.

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.

Patients who have been diagnosed with prostate cancer and are scheduled to undergo brachytherapy and have not received any preoperative treatment for prostate cancer.

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.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Successful MRI Guidance of Transrectal Ultrasound Biopsy in Patients.
Hide Description Ultrasound guidance of transrectal ultrasound biopsy was not attempted.
Time Frame At time of treatment
Hide Outcome Measure Data
Hide Analysis Population 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.
Arm/Group Title Radical Prostatectomy Patients Brachytherapy Patients
Hide Arm/Group 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.

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.

Patients who have been diagnosed with prostate cancer and are scheduled to undergo brachytherapy and have not received any preoperative treatment for prostate cancer.

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.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Radical Prostatectomy Patients Brachytherapy Patients
Hide Arm/Group 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.

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.

Patients who have been diagnosed with prostate cancer and are scheduled to undergo brachytherapy and have not received any preoperative treatment for prostate cancer.

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.

All-Cause Mortality
Radical Prostatectomy Patients Brachytherapy Patients
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Radical Prostatectomy Patients Brachytherapy Patients
Affected / at Risk (%) Affected / at Risk (%)
Total   0/60 (0.00%)   0/5 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Radical Prostatectomy Patients Brachytherapy Patients
Affected / at Risk (%) Affected / at Risk (%)
Total   0/60 (0.00%)   0/5 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Robert Grubb, III
Organization: Washington University
Phone: 314 454-7185
EMail: grubbr@wudosis.wustl.edu
Layout table for additonal 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: October 31, 2018