Low Grade Prostate Cancer
Conditions
Keywords
prostate, cancer, ablation, laser-induced, focal therapy
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.
Interventions
PROCEDURELaser-based thermotherapy
MRI-guided transperineal placement of a laser probe into the prostate
Sponsors
Visualase, Inc.
University of Chicago
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
45 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients with adverse events | Within 6 months of the procedure |
Countries
United States
Outcome results
None listed