Spots Global Cancer Trial Database for Ultrasound in Treating Patients With Prostate Cancer Confined to the Prostate

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Ultrasound in Treating Patients With Prostate Cancer Confined to the Prostate

Official Title: Feasibility Study for Organ Confined Prostate Cancer Treatment With HIFU Using SONABLATE System

Study ID: NCT00030290

Conditions

Prostate Cancer

Interventions

high-intensity focused ultrasound ablation

Study Description

Brief Summary: RATIONALE: Highly focused ultrasound energy may be able to kill cancer cells by heating the tumor without affecting the surrounding tissue. PURPOSE: Phase I trial to study the effectiveness of focused ultrasound energy in treating patients who have prostate cancer that has not spread beyond the prostate.

Detailed Description: OBJECTIVES: * Determine the ability of Sonablate to focus ultrasonic waves for the purpose of selectively destroying prostate cancer tissue, with resultant drop in PSA levels to below 0.5 ng/mL and negative biopsy for cancer cells, in patients with organ-confined prostate cancer. OUTLINE: This is a multicenter study. A probe is inserted into the rectum. High-intensity focused ultrasound (HIFU) energy using the Sonablate system is delivered to the prostate tissue over approximately 2-3 hours. Patients with residual cancer lesion (by biopsy), PSA greater than 0.5 ng/mL or increasing PSA levels taken at least 2 months apart, visible prostate tissue on ultrasound, and no local or distant metastases after day 90 undergo retreatment with HIFU. Patients are followed at 2, 14, 30, 90, and 180 days. PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.