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High-Intensity Focused Ultrasound Therapy in Treating Patients With Localized Prostate Cancer

00:15 EDT 16th April 2014 | BioPortfolio

Summary

RATIONALE: High-intensity focused ultrasound energy may be able to kill tumor cells by heating them without affecting normal tissue.

PURPOSE: This phase II trial is studying how well high-intensity focused ultrasound ablation therapy works in treating patients with localized prostate cancer.

Description

OBJECTIVES:

Primary

- To determine patient acceptability, feasibility, and side-effect profile by evaluating records of adverse events.

- To determine patient acceptability, feasibility, and side-effect profile by evaluating urinary symptoms and erectile function before study stage 1 (verification), before study stage 2 (treatment), and at each follow-up visit.

Secondary

- To determine the effectiveness of therapy by post-treatment transrectal ultrasound-guided biopsies at 6 months and if there is evidence of biochemical failure.

- To determine the effectiveness of therapy by post-treatment MRI to evaluate area of necrosis and presence of any residual tissue.

- To determine the effectiveness of therapy by measurement of prostate-specific antigen (PSA) at each follow-up visit and measurement of time to PSA nadir.

- To determine the effectiveness of therapy by recording the need for secondary or adjuvant treatment following therapy.

OUTLINE: Patients undergo hemiablation using high-intensity focused ultrasound to the side of the prostate with cancer and up to 5 mm over into the contralateral side to ensure adequacy.

Patients complete questionnaires periodically during study to assess urinary symptoms and erectile dysfunction. These include the International Index of Erectile Function-15 [IIEF-15]; the International Prostate Symptom Score [IPSS] and IPSS-QoL; the Functional Assessment of Cancer Therapy - Prostate (FACT-P); and the Continence Questionnaire.

After completion of study treatment, patients are followed at 2-7 days, 7-14 days, and at 1, 3, 6, 9, and 12 months.

Study Design

Primary Purpose: Treatment

Conditions

Prostate Cancer

Intervention

questionnaire administration, high-intensity focused ultrasound ablation, quality-of-life assessment

Location

University College of London Hospitals
London
England
United Kingdom
WIT 3AA

Status

Recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Medical and Biotech [MESH] Definitions

The use of focused, high-frequency sound waves to destroy tissue. It is sometimes used in conjunction with but is distinct from INTERVENTIONAL ULTRASONOGRAPHY.

Tissue ablation of the PROSTATE performed by ultrasound from a transducer placed in the RECTUM. The procedure is used to treat prostate cancer (PROSTATIC NEOPLASMS) and benign prostatic hypertrophy (PROSTATIC HYPERPLASIA).

The application of high intensity ultrasound to liquids.

The destruction of a calculus of the kidney, ureter, bladder, or gallbladder by physical forces, including crushing with a lithotriptor through a catheter. Focused percutaneous ultrasound and focused hydraulic shock waves may be used without surgery. Lithotripsy does not include the dissolving of stones by acids or litholysis. Lithotripsy by laser is LITHOTRIPSY, LASER.

A non-invasive technique using ultrasound for the measurement of cerebrovascular hemodynamics, particularly cerebral blood flow velocity and cerebral collateral flow. With a high-intensity, low-frequency pulse probe, the intracranial arteries may be studied transtemporally, transorbitally, or from below the foramen magnum.

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