Focal Laser Ablation of Low to Intermediate Prostate Cancer Tumors

NCT ID: NCT02600156

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-01

Study Completion Date

2025-12-09

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single arm study

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

Group Type EXPERIMENTAL

Focal laser ablation of the prostate

Intervention Type PROCEDURE

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

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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Visualase Laser Ablation

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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David A. Woodrum

David A. Woodrum, M.D., Ph.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David Woodrum, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Minnesota

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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14-005500

Identifier Type: -

Identifier Source: org_study_id