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.

Eligibility Criteria:
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