Focal Laser Ablation of Low to Intermediate Prostate Cancer Tumors

Prostate Cancer Clinical Trial

Official title:

A Pilot Study to Evaluate Magnetic Resonance Thermal Image-Guided Focal Laser Ablation of Prostate Cancer Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02600156
• Other study ID #: 14-005500
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2015
• Est. completion date: December 2025

Study information

• Verified date: December 2023
• Source: Mayo Clinic
• Contact: Deb Berg
• Phone: 507-255-8454
• Email: rstinterventionaloncology[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years and older

Eligibility

Inclusion Criteria

• Male, 45 years of age or older.
• Diagnosis of prostate adenocarcinoma.
• Clinical stage T1c or T2a.
• Gleason score of 7 (3+4 or 4+3) or Intermediate risk Gleason 6
• PSA less than or equal to 20 ng/mL
• Three or fewer biopsy locations with prostate cancer which correlate with MRI findings.
• No lesion > or = 2cm
• One, two, or three tumor suspicious regions identified on multiparametric MRI
• No definite radiographic indication of extra-capsular extension.
• Estimated survival of 5 years or greater, as determined by treating physician.
• Tolerance for anesthesia/sedation.
• Ability to give informed consent. Exclusion Criteria
• Presence of any condition (e.g., metal implant, shrapnel) not compatible with MRI.
• History of other primary non-skin malignancy within previous three years.

Related Conditions & MeSH terms

• Prostate Adenocarcinoma
• Prostate Cancer
• Prostatic Neoplasms
• Stage I Prostate Cancer AJCC v8
• Stage II Prostate Cancer AJCC v8

Intervention

Procedure:
• Focal laser ablation of the prostate
MR guided laser ablation of the focal prostatic lesion which has been identified by MRI and biopsy prior to ablation.

Locations

Country	Name	City	State
United States	Mayo Clinic in Minnesota	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate	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.	3 years
Primary	Incidence of treatment emergent adverse events	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.	3 years
Secondary	Short- and mid-term ablative success	To obtain preliminary data on ablative success using longitudinal MR imaging assessment of treated areas.	3 years

External Links

•   Mayo Clinic Clinical Trials