High-Intensity Focused Ultrasound Ablation in Treating Patients With Progressive Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
RATIONALE: High-intensity focused ultrasound 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 ablation and to see how well it works in treating patients with progressive prostate cancer.

Detailed Description
-----------------
OBJECTIVES: Primary To evaluate the side effects and patient-reported quality of life outcomes of the index (largest) lesion treatment with high-intensity focused ultrasound ablation in patients with progressive ≤ T3b, N0, M0 prostate cancer. Secondary To determine the success of this treatment by demonstrating the absence of cancer in the treated or ablated area on the 6 month post-treatment transrectal ultrasound biopsy. To evaluate the prostate-specific antigen (PSA) kinetics after index lesion ablation treatment in these patients. To evaluate the proportion of these patients who, after undergoing index lesion control treatment, require androgen blockade at the 12-month follow-up. OUTLINE: Patients undergo transrectal high-intensity focused ultrasound ablation (HIFU) to the index lesion and other identifiable secondary lesions. Patients are evaluated at 6 months and may repeat HIFU treatment. Patients undergo MRI and ultrasound at baseline and periodically thereafter, and blood samples are collected periodically for PSA, renal function, full blood count, and testosterone levels. Patients also complete questionnaires (IPSS, IPSS-QOL, ICS, FACT-P, and IIEF-5) at baseline; at 6 weeks; and at 3, 6, 9 and 12 months. After completion of study treatment, patients are followed at 2 and 6 weeks and at 3, 6, 9, and 12 months.

Official Title
-----------------
An Evaluation of Lesion Control Using Focal Ablation With High Intensity Focused Ultrasound in the Treatment of Non-Metastatic Progressive Prostate Cancer

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Other: pharmacological study
* Other: questionnaire administration
* Procedure: assessment of therapy complications
* Procedure: high-intensity focused ultrasound ablation
* Procedure: quality-of-life assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Histologically confirmed prostate cancer on transrectal ultrasound or transperineal template prostate biopsies meeting the following criteria: Stage ≤ T3b, N0, M0 disease Gleason score ≤ 8 Serum PSA ≤ 20 ng/mL No metastatic disease and nodal spread by staging CT or MRI Negative bone scan within the past 6 months Index lesion or other secondary lesions with a volume of ≥ 0.5 cc by MRI Secondary lesions are included in the treatment provided ≥ 1 neurovascular bundle and 40-50% of prostatic tissue can be preserved PATIENT CHARACTERISTICS: Able to tolerate a transrectal ultrasound Able to undergo major surgery as assessed by a consultant anesthesiologist Able to undergo MRI scanning (i.e., no severe claustrophobia, permanent cardiac pacemaker, metallic implant) No urethral stricture or presence of metal implants or stents in the urethra No prostatic calcification or cysts (on transrectal ultrasound) that would interfere with effective delivery of HIFU therapy No allergy to latex PRIOR CONCURRENT THERAPY: No prior radiotherapy No prior treatment with any of the following: Transurethral resection of the prostate or equivalent procedures within the past 2 years High-intensity focused ultrasound ablation (HIFU) Cryosurgery Thermal or microwave therapy to the prostate No prior significant rectal surgery that prevents insertion of the transrectal HIFU probe More than 12 months since prior androgen suppression or hormone treatment for prostate cancer
Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: pharmacological study|nan|
|Other: questionnaire administration|nan|
|Procedure: assessment of therapy complications|nan|
|Procedure: high-intensity focused ultrasound ablation|nan|
|Procedure: quality-of-life assessment|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects and patient-reported quality of life after treatment as measured by IPSS, IPSS-QOL, ICS, FACT-P, and IIEF-5 questionnaires at baseline, 6 weeks, and 3, 6, 9 and 12 months |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success of treatment as demonstrated by the absence of cancer at 6 months |  |  | 
| PSA kinetics after completion of treatment |  |  | 
| Proportion of patients requiring androgen blockade at 12 months |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer