Focal Laser Ablation of Low to Intermediate Prostate Cancer Tumors

NCT02600156 | Completed

• 1 other identifier: 14-005500
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; Prostate Adenocarcinoma; Stage I Prostate Cancer AJCC v8; Stage II Prostate Cancer AJCC v8; Localized Prostate Carcinoma

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Short- and mid-term ablative success

  3 years

Study Arms (1)

Single arm study

EXPERIMENTAL

MR guided focal laser ablation of prostate cancer using the Visualase Thermal Therapy System.

Procedure: Focal laser ablation of the prostate

Interventions

Focal laser ablation of the prostate PROCEDURE

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

Also known as: Visualase Laser Ablation

Single arm study

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Presence of any condition (e.g., metal implant, shrapnel) not compatible with MRI.
• History of other primary non-skin malignancy within previous three years.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Minnesota

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• David Woodrum, MD, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: David A. Woodrum, M.D., Ph.D.

Study Record Dates

• First Submitted: September 4, 2015
• First Posted: November 9, 2015
• Study Start: September 1, 2015
• Primary Completion: August 20, 2025
• Study Completion: December 9, 2025
• Last Updated: December 17, 2025

Record last verified: 2025-12

Locations

US (1)