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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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An Evaluation of Hemi-ablation Therapy Using High-Intensity Focused Ultrasound in the Treatment of Localized Adenocarcinoma of the Prostate

Conditions
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Prostate Cancer

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


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate, meeting the following criteria: Gleason score ≤ 7 (patterns 3+4 or 4+3 or less are acceptable) Cancer prostate-confined only Cancer confined to one lobe as defined by transrectal ultrasound (TRUS) biopsy Serum prostate-specific antigen (PSA) ≤ 15 ng/mL Prostate volume ≤ 40 cc OR AP length of prostate < 4 cm Unilateral prostate adenocarcinoma must be verified in stage 1 of this trial unless the patient has had multi-sequence MRI and transperineal template biopsies outside of this trial in similar procedure protocols to this trial No evidence of metastatic disease No intraprostatic calcifications ≥ 10 mm in size in cancer-positive side of prostate PATIENT CHARACTERISTICS: Life expectancy ≥ 5 years No latex allergies No American Society of Anesthesiology surgical risk score III or IV No contraindications to MRI scanning (e.g., severe claustrophobia, permanent cardiac pacemaker, or metallic implant likely to contribute significant artefact to images) Must be fit for general anesthesia or regional anesthesia as assessed by the consultant anesthetist PRIOR CONCURRENT THERAPY: More than 6 months since prior androgen suppression therapy No prior radiotherapy for prostate cancer No prior chemotherapy for prostate cancer No prior significant rectal surgery preventing insertion of transrectal probe No prior transurethral resection of the prostate or laser prostatectomy No prior high-intensity focused ultrasound, cryosurgery, thermal, or microwave therapy to the prostate

Ages Eligible for Study
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Maximum Age: 79 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility |  |  | 
| Adverse events |  |  | 
| Patient acceptability as assessed by Assessment of Cancer Therapy - Prostate (FACT-P), International Prostate Symptom Score (IPSS) , IPSS-Quality of Life, Continence Questionnaire, and 15-Item International Index of Erectile Function |  |  | 
| Side effect profile |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of prostate-specific antigen (PSA) kinetics including time to PSA nadir |  |  | 
| Exclusion of cancer on MRI at 2-7 days and at 6 months |  |  | 
| Transrectal ultrasound biopsies at 6 months |  |  | 
| Need for secondary or adjuvant treatment for prostate cancer following therapy |  |  | 

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