Laser Based Focal Ablation of Low Grade Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01192438
Recruitment Status : Completed
First Posted : September 1, 2010
Last Update Posted : March 27, 2014
Visualase, Inc.
Information provided by (Responsible Party):
University of Chicago

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.

Condition or disease Intervention/treatment Phase
Low Grade Prostate Cancer Procedure: Laser-based thermotherapy Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study to Evaluate Magnetic Resonance Thermal Image-guided Laser-Induced Interstitial Thermal Therapy for Focal Ablation of Prostate Cancer
Study Start Date : January 2010
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Procedure/surgery Procedure: Laser-based thermotherapy
MRI-guided transperineal placement of a laser probe into the prostate
Other Name: Visualase, Inc

Primary Outcome Measures :
  1. Number of patients with adverse events [ Time Frame: Within 6 months of the procedure ]

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01192438

United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60616
Sponsors and Collaborators
University of Chicago
Visualase, Inc.
Principal Investigator: Scott E Eggener, MD University of Chicago

Responsible Party: University of Chicago Identifier: NCT01192438     History of Changes
Other Study ID Numbers: 09-364A
First Posted: September 1, 2010    Key Record Dates
Last Update Posted: March 27, 2014
Last Verified: March 2014

Keywords provided by University of Chicago:
focal therapy

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases