MR-Guided Laser Interstitial Thermal Therapy in Treating Patients With Prostate Cancer
|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 therapyProcedure: 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.
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|