Laser Based Focal Ablation of Low Grade Prostate Cancer
This study has been completed.
Sponsor:
University of Chicago
Collaborator:
Visualase, Inc.
Information provided by (Responsible Party):
Scott Eggener, University of Chicago
ClinicalTrials.gov Identifier:
NCT01192438
First received: August 27, 2010
Last updated: June 12, 2012
Last verified: June 2012
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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 | Phase |
|---|---|---|
|
Low Grade Prostate Cancer |
Procedure: Laser-based thermotherapy |
Phase 1 |
| 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) |
Intervention Details:
-
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: | Scott Eggener, Asst Professor Surgery, University of Chicago |
| ClinicalTrials.gov Identifier: | NCT01192438 History of Changes |
| Other Study ID Numbers: | 09-364A |
| Study First Received: | August 27, 2010 |
| Last Updated: | June 12, 2012 |
| 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 May 19, 2013