A Pilot Study to Evaluate Magnetic Resonance Thermal Image-guided Laser-Induced Interstitial Thermal Therapy for Focal Ablation of Prostate Cancer

University of Chicago1 site in 1 country9 target enrollmentJanuary 2010

Overview

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

Registry

clinicaltrials.gov

Start Date

January 2010

End Date

September 2011

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Sponsor

Responsible Party

Sponsor

•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

•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