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

Study Overview
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Brief Summary
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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
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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.

Official Title
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HIFU Lesion Control in Patients With Non-metastatic Progressive Prostate Cancer

Conditions
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Prostate Cancer, Sexual Dysfunction

Intervention / Treatment
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* Other: laboratory biomarker analysis
* Other: questionnaire administration
* Procedure: assessment of therapy complications
* 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 prostate cancer by transrectal or transperineal template prostate biopsies Stage ≤ T3bN0M0 Gleason grade ≤ 8 Serum PSA ≤ 20 ng/mL Bone scan- or cross-sectional imaging-negative for metastatic or nodal (outside prostate) disease No metastatic disease and/or nodal spread by CT scan or MRI Index lesion or other secondary lesions with a volume ≥ 0.5 cc by MRI No prostatic calcification and cysts (on transrectal ultrasound) that would interfere with effective delivery of therapy PATIENT CHARACTERISTICS: Able to tolerate a transrectal ultrasound Not allergic to latex Fit for major surgery as assessed by a consultant anaesthetist Able to have MRI scanning (i.e., none of the following conditions: severe claustrophobia, permanent cardiac pacemaker, metallic implant, etc.) PRIOR CONCURRENT THERAPY: No prior radiotherapy No androgen suppression and/or hormone treatment within the past 12 months No prior significant rectal surgery preventing insertion of transrectal high-intensity focused ultrasound (HIFU) probe (decided on the type of surgery in individual cases) No prior transurethral resection of the prostate (or equivalent procedures) within the past 2 years No prior HIFU, cryosurgery, thermal, or microwave therapy to the prostate
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
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: laboratory biomarker analysis|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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total proportion of men with erectile dysfunction and/or incontinence |  |  | 
| Quality of life |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success of index lesion ablation with HIFU at 6 months |  |  | 
| Prostate-specific antigen kinetics |  |  | 
| Proportion of men requiring androgen blockade at 12 months |  |  | 

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