Spots Global Cancer Trial Database for High-Intensity Focused Ultrasound Focal Ablation in Treating Patients With Progressive Prostate Cancer

Study Description

Brief Summary: RATIONALE: High-intensity focused ultrasound focal ablation uses high-energy sound waves to kill tumor cells. PURPOSE: This phase II trial is studying the side effects of high-intensity focused ultrasound focal ablation and to see how well it works in treating patients with progressive prostate cancer.

Detailed Description: OBJECTIVES: Primary * To evaluate the side effects of high-intensity focused ultrasound (HIFU) ablation in men with non-metastatic progressive prostate cancer. * To evaluate the quality of life of patients treated with this regimen. Secondary * To determine the success of index lesion ablation with HIFU at 6 months after treatment by demonstrating the absence of cancer in the treated or ablated area by transrectal ultrasound biopsy. * To evaluate the prostate-specific antigen kinetics after index lesion ablation in patients treated with this regimen. * To evaluate the proportion of men who require androgen blockade at 12 months of follow-up. OUTLINE: Patients undergo focal ablation with high-intensity focused ultrasound (HIFU) ablation on day 1. Treatment may repeat at 6 months in patients with progressive disease. Blood samples and prostate biopsies are collected periodically for further analysis. Patients complete questionnaires (IPSS, IPSS-QoL, ICS, IIEF-5, and FACT-P) at baseline and periodically during study.

Keywords

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

Contact Details

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