MR Image Guided Focal Therapy in Prostate Cancer
- Pilot study is designed to evaluate the safety and feasibility of thermal laser
ablation of focal prostate tumors.
- Prostate cancer is relatively slow growing, with doubling times for local tumors
estimated at 2 to 4 years.
- Some prostate cancers prove to be small, low grade, and noninvasive and they appear to
pose little risk to the life or health of the host. Recent patient series suggest that
20% to 30% of men undergoing radical prostatectomy have pathologic features in the
radical prostatectomy specimen consistent with an insignificant or indolent cancer
which poses little threat to life or health.
- We propose that patients with low volume and low grade disease can be best served with
focal ablation of the visible prostate cancer without the side effects of urinary
incontinence and erectile dysfunction associated with radiation therapy or radical
-To determine feasibility and safety of magnetic resonance image-guided focal laser ablation
of biopsy confirmed and MR visible prostate cancer.
- To evaluate tolerability of treatment
- To determine changes in imaging and biopsy characteristics after thermal ablation of
localized prostate cancer
- To obtain preliminary data, as a follow-up to this study, regarding the effect of
thermal ablation using Visualase on short and long term complication rate.
- To compare Visualase estimates of thermal damage to post contrast MRI images.
- Determine outcome of laser ablation for treatment of prostate cancer using serial PSA,
PSA density, changes in imaging, IPSS, and SHIM.
- Greater than 18 years of age
- Organ confined prostate cancer, observed on MR, and confirmed by Transrectal biopsy
- Preoperative workup as dictated by the NCCN.org prostate cancer guidelines
- PSA < 15 ng or PSA density < 0.15 ng/ml in patients with a PSA > 15 ng
- Pilot study, testing feasibility, safety and tolerability of thermal ablation of focal
- It is anticipated that 15 patients will be accrued for this study
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine feasibility and safety of magnetic resonance image-guided focal laser ablation of biopsy confirmed and MR visible prostate cancer.
Peter A Pinto, M.D.
National Cancer Institute (NCI)
United States: Federal Government
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Bethesda, Maryland 20892|