MR-Guided Laser Interstitial Thermal Therapy in Treating Patients With Prostate Cancer
|Stage I Prostate Cancer Stage II Prostate Carcinoma||Device: Visualase Thermal Therapy Procedure: magnetic resonance imaging Procedure: quality-of-life assessment||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||PHASE II EVALUATION OF MR-GUIDED LASERINDUCED INTERSTITIAL THERMAL THERAPY (LITT) FOR PROSTATE CANCER|
- 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 ]
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||July 2017|
|Estimated Primary Completion Date:||July 2017 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|