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