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

University College London Hospitals60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Enrollment

Conditions

Prostate Cancer

Interventions

questionnaire administrationOTHER

high-intensity focused ultrasound ablationPROCEDURE

quality-of-life assessmentPROCEDURE

Eligibility

Sex: MALEMax age: 79 Years

Medical Language ↔ Plain English

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

Locations (1)

University College of London Hospitals

London, England, United Kingdom

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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