NCT01792024

MR-Guided Laser Interstitial Thermal Therapy in Treating Patients With Prostate Cancer

Phase II Evaluation of MR-Guided Laser Induced Interstitial Thermal Therapy (LITT) for Prostate Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: University of Chicago · Academic / Other
• Sex: Male
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well magnetic resonance (MR)-guided laser interstitial thermal therapy works in treating patients with prostate cancer. Laser therapy uses intense, narrow beams of light to cut and destroy tissue and may help treat prostate cancer

Detailed description

PRIMARY OBJECTIVES: 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. SECONDARY OBJECTIVES: 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. OUTLINE: Patients undergo MR-guided LITT. After completion of study treatment, patients are followed up at 1, 3, and 12 months.

Conditions

• Stage I Prostate Cancer
• Stage II Prostate Carcinoma

Interventions

Type	Name	Description
DEVICE	Visualase Thermal Therapy	MR guided laser ablation of prostate cancer
PROCEDURE	magnetic resonance imaging	Undergo MR-guided LITT

Timeline

• Start date: 2013-01-28
• Primary completion: 2015-09-16
• Completion: 2015-09-16
• First posted: 2013-02-15
• Last updated: 2018-03-13
• Results posted: 2018-03-13

Locations

1 site across 1 country: United States