This clinical trial evaluates the safety and effectiveness of magnetic resonance imaging (MRI)-guided focal laser therapy with the Visualase Thermal Therapy System to treat low to intermediate risk prostate cancer tumors. Unlike surgery or radiotherapy which affects a large portion of the prostate or the entire organ, localized or focal therapy is intended to treat a small portion of tissue in which the cancer has been found by biopsy. MR-thermal guided laser ablation may kill tumor cells by heating them to several degrees above normal body temperature without affecting the surrounding tissue.
Additional locations may be listed on ClinicalTrials.gov for NCT02600156.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVES:
I. To evaluate the feasibility and safety of MRI-guided focal laser ablation (Laser-Induced Interstitial Thermal Therapy [LITT]) to treat low-risk prostate cancer.
II. To evaluate the procedural success rate of using the magnetic resonance (MR)-guided laser ablation to target, access, thermally monitor, and focally ablate MR-visible prostate cancer lesions.
III. To evaluate patient-related safety by monitoring short and long-term complications through use of standardized and validated toxicity and quality-of-life instruments.
SECONDARY OBJECTIVE:
I. To obtain preliminary data on ablative success using longitudinal MR imaging and long term biopsy assessment of treated areas.
OUTLINE:
Patients undergo multi-parametric MRI to visualize the prostate cancer throughout the study. Patients undergo MRI ultrasound fusion guided biopsy or MR-guided biopsy on study. Patients then undergo MR-thermal image guided focal laser ablation of all biopsy proven areas of prostate cancer on study. Patients also undergo a collection of blood on study.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationMayo Clinic in Rochester
Principal InvestigatorDavid A. Woodrum
