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
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
MR guided laser ablation of prostate cancer
Undergo MR-guided LITT
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Number of Participants With Undetectable Cancer on MRI-guided Biopsy of Ablation Zone Following Treatment
The primary study end point was the number of patients with no cancer on MRI guided biopsy of the ablation zone at 3 months.
Time frame: At 3 months after ablation
The Number of Patients With Biopsy Cancer of the Treatment Zone
A systematic 12-core biopsy was performed at 1 year and the number of patients with biopsy cancer was counted.
Time frame: At 12 months
The Total Number of Patients With Any Adverse Events Related to the Treatment
Treatment-related toxicity measured by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Time frame: 1,3, and 12 month after treatment and 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)
International Prostate Symptom Score (IPSS) measures urinary symptoms and continence and it ranged 0 to 35. Lower values are considered better outcome.
Time frame: At 1,3 and 12 months
Quality of Life in Terms of Urinary and Sexual Function in the Year Following Treatment Assessed Using Sexual Health Inventory in Men (SHIM)
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.
Time frame: At 1,3 and 12 months
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