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Laser Based Focal Ablation of Low Grade Prostate Cancer

Primary Purpose

Low Grade Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Laser-based thermotherapy
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Grade Prostate Cancer focused on measuring prostate, cancer, ablation, laser-induced, focal therapy

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 or less
  • A minimum of 12 biopsy cores sampled during diagnostic biopsy
  • Three or fewer biopsy cores with prostate cancer
  • No single biopsy core with greater than 50% of tumor involvement
  • A radiographically visible prostate lesion on MRI with concordance to biopsy sextant
  • A documented Karnofsky performance status of at least 70
  • Estimated survival of 20 years or greater, as determined by treating physician
  • Ability to give informed consent

Exclusion Criteria:

  • Previous surgery, radiation, or androgen deprivation therapy for prostate cancer
  • Presence of any condition (e.g., metal implant, shrapnel) not compatible with MRI
  • History of previous pelvic radiation
  • Severe lower urinary tract symptoms as measured by an International Prostate Symptom Score (IPSS) of 20 or greater. (See Appendix A)
  • History of other primary non-skin malignancy within previous three years

Sites / Locations

  • University of Chicago

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Procedure/surgery

Arm Description

Outcomes

Primary Outcome Measures

Number of patients with adverse events

Secondary Outcome Measures

Full Information

First Posted
August 27, 2010
Last Updated
March 26, 2014
Sponsor
University of Chicago
Collaborators
Visualase, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01192438
Brief Title
Laser Based Focal Ablation of Low Grade Prostate Cancer
Official Title
A Pilot Study to Evaluate Magnetic Resonance Thermal Image-guided Laser-Induced Interstitial Thermal Therapy for Focal Ablation of Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
Collaborators
Visualase, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the safety of MRI-guided laser-induced thermal therapy of biopsy confirmed low-risk prostate cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Grade Prostate Cancer
Keywords
prostate, cancer, ablation, laser-induced, focal therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Procedure/surgery
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Laser-based thermotherapy
Other Intervention Name(s)
Visualase, Inc
Intervention Description
MRI-guided transperineal placement of a laser probe into the prostate
Primary Outcome Measure Information:
Title
Number of patients with adverse events
Time Frame
Within 6 months of the procedure

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 or less A minimum of 12 biopsy cores sampled during diagnostic biopsy Three or fewer biopsy cores with prostate cancer No single biopsy core with greater than 50% of tumor involvement A radiographically visible prostate lesion on MRI with concordance to biopsy sextant A documented Karnofsky performance status of at least 70 Estimated survival of 20 years or greater, as determined by treating physician Ability to give informed consent Exclusion Criteria: Previous surgery, radiation, or androgen deprivation therapy for prostate cancer Presence of any condition (e.g., metal implant, shrapnel) not compatible with MRI History of previous pelvic radiation Severe lower urinary tract symptoms as measured by an International Prostate Symptom Score (IPSS) of 20 or greater. (See Appendix A) History of other primary non-skin malignancy within previous three years
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott E Eggener, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60616
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Laser Based Focal Ablation of Low Grade Prostate Cancer

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