high-intensity focused ultrasound therapy in treating patients with localized prostate cancer

Conditions: Prostate Cancer

Summary: 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

Keywords: adenocarcinoma of the prostate stage i prostate cancer stage iib prostate cancer stage iia prostate cancer stage iii prostate cancer