MR-Guided Laser Interstitial Thermal Therapy in Treating Patients With Prostate Cancer
|ClinicalTrials.gov Identifier: NCT01792024|
Recruitment Status : Completed
First Posted : February 15, 2013
Last Update Posted : September 11, 2017
|Condition or disease||Intervention/treatment|
|Stage I Prostate Cancer Stage II Prostate Carcinoma||Device: Visualase Thermal Therapy Procedure: magnetic resonance imaging Procedure: quality-of-life assessment|
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 LASERINDUCED INTERSTITIAL THERMAL THERAPY (LITT) FOR PROSTATE CANCER|
|Actual Study Start Date :||January 28, 2013|
|Primary Completion Date :||September 16, 2015|
|Study Completion Date :||September 16, 2015|
Experimental: Treatment (LITT)
Patients undergo MR-guided laser ablation of prostate cancer
Device: Visualase Thermal Therapy
MR guided laser ablation of prostate cancer
Other Name: laser interstitial thermal therapyProcedure: magnetic resonance imaging
Undergo MR-guided LITT
Other Names:Procedure: quality-of-life assessment
Other Name: quality of life assessment
- Undetectable cancer on MRI-guided biopsy of ablation zone following treatment [ Time Frame: At 3 months ]
- Oncologic efficacy following treatment based on biopsy of the treatment zone [ Time Frame: At 12 months ]
- Rates and grades of treatment-related toxicity measured by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0 [ Time Frame: Up to 12 months ]
- Quality of life in terms of urinary and sexual function in the year following treatment assessed using the International Prostate Symptom Score (IPSS) and Sexual Health Inventory in Men (SHIM) [ Time Frame: Up to 12 months ]
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|