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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00561314
• Other study ID #: CDR0000574344
• Secondary ID: UCLCTC-UCLH-FOCA
• Status: Completed
• Phase: Phase 2
• First received: November 17, 2007
• Last updated: August 23, 2013
• Start date: July 2007
• Est. completion date: January 2012

Study information

• Verified date: July 2009
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Highly focused ultrasound energy may be able to kill tumor cells by heating the tumor without affecting the surrounding tissue.

PURPOSE: This phase II trial is studying the side effects and how well highly focused ultrasound energy works in treating patients with localized prostate cancer.

Description:

OBJECTIVES:

Primary

• 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.

Secondary

• 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 therapy.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: January 2012
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years to 80 Years

Eligibility

DISEASE CHARACTERISTICS:

• 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

PATIENT CHARACTERISTICS:

• 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

PRIOR CONCURRENT THERAPY:

• No androgen suppression treatment within the past 6 months

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

• 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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms
• Sexual Dysfunction
• Urinary Incontinence

Intervention

Other:
• questionnaire administration

Procedure:
• biopsy

• high-intensity focused ultrasound ablation

• magnetic resonance imaging

• quality-of-life assessment

Locations

Country	Name	City	State
United Kingdom	Basingstoke and North Hampshire NHS Foundation Trust	Basingstoke	England
United Kingdom	University College of London Hospitals	London	England

Sponsors (1)

Lead Sponsor	Collaborator
University College London Hospitals

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Ahmed HU, Hindley RG, Dickinson L, Freeman A, Kirkham AP, Sahu M, Scott R, Allen C, Van der Meulen J, Emberton M. Focal therapy for localised unifocal and multifocal prostate cancer: a prospective development study. Lancet Oncol. 2012 Jun;13(6):622-32. do — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility, patient acceptability and side effect profile of high-intensity focal ultrasound ablation as determined by adverse events			Yes
Primary	Patient acceptability, urinary symptoms, and erectile function as assessed by Functional Assessment of Cancer Treatment-Prostate (FACT-P); Item International Index of Erectile Dysfunction (IIEF-15); International Prostate Symptom Score (IPSS); I ...			No
Secondary	Effectiveness of high-intensity focal ultrasound ablation to control prostate cancer as determined by time to PSA nadir, MRI at 10-20 days and again at 6 months, biopsies of treated areas at 6 months, and by recording the need for secondary or adjuva ...			No