MR-Guided Laser Interstitial Thermal Therapy in Treating Patients With Prostate Cancer
|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.|
|ClinicalTrials.gov Identifier: NCT01792024|
Recruitment Status : Completed
First Posted : February 15, 2013
Results First Posted : March 13, 2018
Last Update Posted : March 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Stage I Prostate Cancer Stage II Prostate Carcinoma||Device: Visualase Thermal Therapy Procedure: magnetic resonance imaging||Not Applicable|
I. To evaluate the oncologic efficacy of laster interstitial thermal therapy (LITT) with primary endpoint of undetectable cancer on magnetic resonance imaging (MRI)-guided biopsy of treatment zone at 3 months following treatment.
I. To evaluate oncologic efficacy at 12 months following treatment based on biopsy of the treatment zone.
II. To determine treatment-related safety and toxicity. III. To longitudinally assess urinary and sexual function in the year following treatment.
Patients undergo MR-guided LITT.
After completion of study treatment, patients are followed up at 1, 3, and 12 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Evaluation of MR-Guided Laser Induced Interstitial Thermal Therapy (LITT) for Prostate Cancer|
|Actual Study Start Date :||January 28, 2013|
|Actual Primary Completion Date :||September 16, 2015|
|Actual Study Completion Date :||September 16, 2015|
Experimental: Treatment (LITT)
Patients undergo Magnetic Resonance imaging (MR) guided laser thermal therapy with Visualase Thermal Therapy device.
Device: Visualase Thermal Therapy
MR guided laser ablation of prostate cancer
Other Name: laser interstitial thermal therapy
Procedure: magnetic resonance imaging
Undergo MR-guided LITT
- Number of Participants With Undetectable Cancer on MRI-guided Biopsy of Ablation Zone Following Treatment [ Time Frame: At 3 months after ablation ]The primary study end point was the number of patients with no cancer on MRI guided biopsy of the ablation zone at 3 months.
- The Number of Patients With Biopsy Cancer of the Treatment Zone [ Time Frame: At 12 months ]A systematic 12-core biopsy was performed at 1 year and the number of patients with biopsy cancer was counted.
- The Total Number of Patients With Any Adverse Events Related to the Treatment [ Time Frame: 1,3, and 12 month after treatment and up to 12 months ]Treatment-related toxicity measured by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0
- Quality of Life in Terms of Urinary and Sexual Function in the Year Following Treatment Assessed Using the International Prostate Symptom Score (IPSS) [ Time Frame: At 1,3 and 12 months ]International Prostate Symptom Score (IPSS) measures urinary symptoms and continence and it ranged 0 to 35. Lower values are considered better outcome.
- Quality of Life in Terms of Urinary and Sexual Function in the Year Following Treatment Assessed Using Sexual Health Inventory in Men (SHIM) [ Time Frame: At 1,3 and 12 months ]Sexual Health Inventory Score in Men (SHIM) measures sexual health and erectile function and it ranged 1 to 25. Lower values are considered better outcome.
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): NCT01792024
|United States, Illinois|
|University of Chicago Comprehensive Cancer Center|
|Chicago, Illinois, United States, 60637-1470|
|Principal Investigator:||Aytekin Oto||University of Chicago Comprehensive Cancer Center|
|Principal Investigator:||Scott Eggener, MD||University of Chicago|