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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 26, 2014