Pilot Study to Investigate Magnetic Resonance (MR) Image Guided Focal Therapy in Prostate Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Prostate Cancer
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
Description
Background: 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...
Background: 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 participants 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 surgery. Focal Therapy for prostate cancer has gained popularity however prior studies demonstrate a failure rate as high as 50% with a laser. Objective: To determine the feasibility of magnetic resonance image (MRI)-guided ultrasound-induced thermal therapy of biopsy-confirmed and MRI visible, prostate tumor(s) using the TULSA Thermal Therapy System (Profound Medical) Eligibility: Subjects with prostate cancer, amenable for ultrasound ablation Organ confined clinical T1c or clinical T2a prostate cancer, visible on MRI, and confirmed by prostate biopsy Adequate organ and marrow function Prostate-specific antigen (PSA) < 20 ng/ml Age >=18 years Design: Study testing feasibility and tolerability of ultrasound ablation of focal prostate cancer. It is anticipated that 15 participants will be accrued for this study.
Tracking Information
- NCT #
- NCT04808427
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Peter A Pinto, M.D. National Cancer Institute (NCI)
Get Well Soon