Laser Based Focal Ablation of Low Grade Prostate Cancer

This study has been completed.
Sponsor:
Collaborator:
Visualase, Inc.
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01192438
First received: August 27, 2010
Last updated: March 26, 2014
Last verified: March 2014
  Purpose

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 Intervention
Low Grade Prostate Cancer
Procedure: Laser-based thermotherapy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Number of patients with adverse events [ Time Frame: Within 6 months of the procedure ] [ Designated as safety issue: Yes ]

Enrollment: 9
Study Start Date: January 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Procedure/surgery Procedure: Laser-based thermotherapy
MRI-guided transperineal placement of a laser probe into the prostate
Other Name: Visualase, Inc

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01192438

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

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01192438     History of Changes
Other Study ID Numbers: 09-364A
Study First Received: August 27, 2010
Last Updated: March 26, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Chicago:
prostate
cancer
ablation
laser-induced
focal therapy

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

ClinicalTrials.gov processed this record on April 15, 2014