search
Back to results

Focal Laser Ablation of Low to Intermediate Prostate Cancer Tumors

Primary Purpose

Prostate Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Focal laser ablation of the prostate
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Mayo Clinic in MinnesotaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single arm study

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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

Full Information

First Posted
September 4, 2015
Last Updated
October 13, 2023
Sponsor
Mayo Clinic
search

1. Study Identification

Unique Protocol Identification Number
NCT02600156
Brief Title
Focal Laser Ablation of Low to Intermediate Prostate Cancer Tumors
Official Title
A Pilot Study to Evaluate Magnetic Resonance Thermal Image-Guided Focal Laser Ablation of Low to Intermediate Prostate Cancer Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2015 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single arm study
Arm Type
Experimental
Arm Description
MR guided focal laser ablation of prostate cancer using the Visualase Thermal Therapy System.
Intervention Type
Procedure
Intervention Name(s)
Focal laser ablation of the prostate
Other Intervention Name(s)
Visualase Laser Ablation
Intervention Description
MR guided laser ablation of the focal prostatic lesion which has been identified by MRI and biopsy prior to ablation.
Primary Outcome Measure Information:
Title
Success rate
Description
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.
Time Frame
3 years
Title
Incidence of treatment emergent adverse events
Description
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.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Short- and mid-term ablative success
Description
To obtain preliminary data on ablative success using longitudinal MR imaging assessment of treated areas.
Time Frame
3 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Deb Berg
Phone
507-255-8454
Email
rstinterventionaloncology@mayo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Woodrum, MD, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Minnesota
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deb Berg
Phone
507-255-8454
Email
rstinterventionaloncology@mayo.edu
First Name & Middle Initial & Last Name & Degree
David A. Woodrum, M.D., Ph.D

12. IPD Sharing Statement

Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

Focal Laser Ablation of Low to Intermediate Prostate Cancer Tumors

We'll reach out to this number within 24 hrs