Focal Laser Ablation of Low to Intermediate Prostate Cancer Tumors

Not Applicable

Active, not recruiting

• Conditions: Prostate Adenocarcinoma; Stage I Prostate Cancer AJCC v8; Stage II Prostate Cancer AJCC v8; Prostate Cancer; Localized Prostate Carcinoma

• Registration Number: NCT02600156
• Lead Sponsor: Mayo Clinic

Brief Summary

The primary purpose of this study is to evaluate the feasibility and safety of MRI-guided focal laser ablation (Laser-Induced Interstitial Thermal Therapy, LITT) to treat low-risk native prostate cancer.

Detailed Description

The study is being done to evaluate the safety and effectiveness of Magnetic Resonance Imaging (MRI)-guided focal laser therapy with the Visualase Thermal Therapy System to treat low-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.

Study Timeline

• Study Start: 2015-09-01
• Study First Submitted: 2015-09-04
• Study First Submitted QC: 2015-11-05
• Study First Posted: 2015-11-09
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-22
• Last Update Posted: 2025-04-23
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 7

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Incidence of treatment emergent adverse events	3 years	To evaluate patient-related safety by monitoring short and long-term complications related to the procedure such as but not limited to incontinence, impotence, and urethral fistulas.
Success rate	3 years	To evaluate the procedural success rate of using the MR-guided laser ablation to target, access, thermally monitor, and focally ablate MR-visible prostate cancer lesions.

Secondary Outcome Measures

Name	Time	Method
Short- and mid-term ablative success	3 years	To obtain preliminary data on ablative success using longitudinal MR imaging assessment of treated areas.

Trial Locations

Locations (1)

Mayo Clinic in Minnesota; 🇺🇸 Rochester, Minnesota, United States