- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01192438
Laser Based Focal Ablation of Low Grade Prostate Cancer
March 26, 2014 updated by: University of Chicago
A Pilot Study to Evaluate Magnetic Resonance Thermal Image-guided Laser-Induced Interstitial Thermal Therapy for Focal Ablation of Prostate Cancer
The purpose of this study is to evaluate the safety of MRI-guided laser-induced thermal therapy of biopsy confirmed low-risk prostate cancer.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
9
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60616
- University of Chicago
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Male, 45 years of age or older
- Diagnosis of prostate adenocarcinoma
- Clinical stage T1c or T2a
- Gleason score of 7 or less
- A minimum of 12 biopsy cores sampled during diagnostic biopsy
- Three or fewer biopsy cores with prostate cancer
- No single biopsy core with greater than 50% of tumor involvement
- A radiographically visible prostate lesion on MRI with concordance to biopsy sextant
- A documented Karnofsky performance status of at least 70
- Estimated survival of 20 years or greater, as determined by treating physician
- Ability to give informed consent
Exclusion Criteria:
- Previous surgery, radiation, or androgen deprivation therapy for prostate cancer
- Presence of any condition (e.g., metal implant, shrapnel) not compatible with MRI
- History of previous pelvic radiation
- Severe lower urinary tract symptoms as measured by an International Prostate Symptom Score (IPSS) of 20 or greater. (See Appendix A)
- History of other primary non-skin malignancy within previous three years
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Procedure/surgery
|
MRI-guided transperineal placement of a laser probe into the prostate
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of patients with adverse events
Time Frame: Within 6 months of the procedure
|
Within 6 months of the procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Scott E Eggener, MD, University of Chicago
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Actual)
September 1, 2011
Study Completion (Actual)
September 1, 2011
Study Registration Dates
First Submitted
August 27, 2010
First Submitted That Met QC Criteria
August 31, 2010
First Posted (Estimate)
September 1, 2010
Study Record Updates
Last Update Posted (Estimate)
March 27, 2014
Last Update Submitted That Met QC Criteria
March 26, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09-364A
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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