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An Evaluation of Focal Ablation Therapy Using High-Intensity Focused Ultrasound in the Treatment of Localized Adenocarcinoma of the Prostate

Phase 2
45 Years
80 Years
Open (Enrolling)
Prostate Cancer, Sexual Dysfunction and Infertility, Urinary Incontinence

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Trial Information

An Evaluation of Focal Ablation Therapy Using High-Intensity Focused Ultrasound in the Treatment of Localized Adenocarcinoma of the Prostate



- To evaluate feasibility, side effect profile, and patient acceptability of
high-intensity focused ultrasound ablation in patients with organ-confined, MRI and
histologically proven adenocarcinoma of the prostate.


- To determine the effectiveness of therapy via biopsy, MRI, PSA level and estimated time
to PSA nadir, and by recording the need for secondary or adjuvant treatment following

OUTLINE: A probe is inserted into the rectum. High-intensity focused ultrasound (HIFU)
energy using the Sonablate system is delivered to the prostate tissue over approximately 2
hours. Patients are then evaluated over a 12-month period.

Patients undergo multi-sequence MRI within 10-20 days after HIFU to assess the extent and
volume of tumor necrosis and again at 6 months to assess for disease recurrence. Blood is
collected for PSA levels at baseline and then at 1, 3, 6, 9, and 12 months. Patients also
undergo transrectal ultrasound biopsy at 6 months to evaluate disease response.

Patients complete questionnaires at baseline and at 1, 3, 6, 9, and 12 months to evaluate
erectile and sexual function, urinary flow and continence, and quality-of-life.

Inclusion Criteria


- Histologically confirmed adenocarcinoma of the prostate

- Low-risk disease, as defined by the following criteria:

- Gleason grade total ≤ 7 (patterns 3+4 or 4+3 or less acceptable)

- Localized disease (unilateral or bilateral) (stage T2c, N0, M0 or less)

- Serum PSA ≤ 15 ng/mL

- Prostate volume ≤ 40 cc or maximum anterior-posterior length ≤ 40 mm

- Multi-sequence-MRI and transperineal template 5 mm-spaced biopsies performed within
the past 6 months

- All malignant areas must be treatable by focal ablation so that approximately 50% of
prostate tissue is destroyed and ≥ 1 neurovascular bundle is preserved

- No intraprostatic calcifications making high-intensity focused ultrasound of focal
areas of cancer untreatable

- No metastatic disease


- Life expectancy ≥ 5 years

- Must be fit for general or regional anesthesia as assessed by Consultant Anesthetist

- No prior rectal fistula

- No American Society of Anesthesiology grades III-IV

- No latex allergies

- No contraindication to MRI scanning (e.g., severe claustrophobia, permanent cardiac
pacemaker, or metallic implant likely to contribute significant artifact to images)

- No moderate to severe inflammatory bowel disease


- No androgen suppression treatment within the past 6 months

- No transurethral resection of the prostate or laser prostatectomy within the past 5

- No prior treatment (i.e., radiotherapy, brachytherapy, surgery, laser therapy,
chemotherapy, high-intensity focused ultrasound, cryosurgery, thermal therapy, or
microwave therapy) for prostate cancer

- No prior significant rectal surgery preventing insertion of transrectal probe

Type of Study:


Study Design:

Primary Purpose: Treatment

Outcome Measure:

Feasibility, patient acceptability and side effect profile of high-intensity focal ultrasound ablation as determined by adverse events

Safety Issue:


Principal Investigator

Mark Emberton, MD, FRCS, MBBS

Investigator Role:

Study Chair

Investigator Affiliation:

University College London Hospitals



Study ID:




Start Date:

July 2007

Completion Date:

Related Keywords:

  • Prostate Cancer
  • Sexual Dysfunction and Infertility
  • Urinary Incontinence
  • sexual dysfunction and infertility
  • urinary incontinence
  • adenocarcinoma of the prostate
  • stage I prostate cancer
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • Adenocarcinoma
  • Prostatic Neoplasms
  • Infertility
  • Sexual Dysfunctions, Psychological
  • Urinary Incontinence