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

An Evaluation of Lesion Control Using Focal Ablation With High Intensity Focused Ultrasound in the Treatment of Non-Metastatic Progressive Prostate Cancer

RATIONALE: High-intensity focused ultrasound ablation uses high-energy sound waves to kill tumor cells.

PURPOSE: This phase II trial is studying the side effects of high-intensity focused ultrasound ablation and to see how well it works in treating patients with progressive prostate cancer.

Study Overview

• Status: Unknown
• Conditions: Prostate Cancer
• Intervention / Treatment: Other: pharmacological study; Other: questionnaire administration; Procedure: quality-of-life assessment; Procedure: assessment of therapy complications; Procedure: high-intensity focused ultrasound ablation

Detailed Description

OBJECTIVES:

Primary

• To evaluate the side effects and patient-reported quality of life outcomes of the index (largest) lesion treatment with high-intensity focused ultrasound ablation in patients with progressive ≤ T3b, N0, M0 prostate cancer.

Secondary

• To determine the success of this treatment by demonstrating the absence of cancer in the treated or ablated area on the 6 month post-treatment transrectal ultrasound biopsy.
• To evaluate the prostate-specific antigen (PSA) kinetics after index lesion ablation treatment in these patients.
• To evaluate the proportion of these patients who, after undergoing index lesion control treatment, require androgen blockade at the 12-month follow-up.

OUTLINE: Patients undergo transrectal high-intensity focused ultrasound ablation (HIFU) to the index lesion and other identifiable secondary lesions. Patients are evaluated at 6 months and may repeat HIFU treatment.

Patients undergo MRI and ultrasound at baseline and periodically thereafter, and blood samples are collected periodically for PSA, renal function, full blood count, and testosterone levels. Patients also complete questionnaires (IPSS, IPSS-QOL, ICS, FACT-P, and IIEF-5) at baseline; at 6 weeks; and at 3, 6, 9 and 12 months.

After completion of study treatment, patients are followed at 2 and 6 weeks and at 3, 6, 9, and 12 months.

• Study Type: Interventional
• Enrollment (Anticipated): 26
• Phase: Phase 2

Contacts and Locations

Study Locations

• United Kingdom
  • England
    • London, England, United Kingdom, WIT 3AA
      • Recruiting
      • University College Hospital
      • Contact: Hashim Uddinn Ahmed, MD; Phone Number: 44-20-7380-9194

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

DISEASE CHARACTERISTICS:

• Histologically confirmed prostate cancer on transrectal ultrasound or transperineal template prostate biopsies meeting the following criteria:

  • Stage ≤ T3b, N0, M0 disease
  • Gleason score ≤ 8
  • Serum PSA ≤ 20 ng/mL

  • No metastatic disease and nodal spread by staging CT or MRI

    • Negative bone scan within the past 6 months

• Index lesion or other secondary lesions with a volume of ≥ 0.5 cc by MRI

  • Secondary lesions are included in the treatment provided ≥ 1 neurovascular bundle and 40-50% of prostatic tissue can be preserved

PATIENT CHARACTERISTICS:

• Able to tolerate a transrectal ultrasound
• Able to undergo major surgery as assessed by a consultant anesthesiologist
• Able to undergo MRI scanning (i.e., no severe claustrophobia, permanent cardiac pacemaker, metallic implant)
• No urethral stricture or presence of metal implants or stents in the urethra
• No prostatic calcification or cysts (on transrectal ultrasound) that would interfere with effective delivery of HIFU therapy
• No allergy to latex

PRIOR CONCURRENT THERAPY:

• No prior radiotherapy

• No prior treatment with any of the following:

  • Transurethral resection of the prostate or equivalent procedures within the past 2 years
  • High-intensity focused ultrasound ablation (HIFU)
  • Cryosurgery
  • Thermal or microwave therapy to the prostate
• No prior significant rectal surgery that prevents insertion of the transrectal HIFU probe
• More than 12 months since prior androgen suppression or hormone treatment for prostate cancer

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Side effects and patient-reported quality of life after treatment as measured by IPSS, IPSS-QOL, ICS, FACT-P, and IIEF-5 questionnaires at baseline, 6 weeks, and 3, 6, 9 and 12 months

Secondary Outcome Measures

Outcome Measure
Success of treatment as demonstrated by the absence of cancer at 6 months
PSA kinetics after completion of treatment
Proportion of patients requiring androgen blockade at 12 months

Collaborators and Investigators

• Sponsor: University College London Hospitals
• Investigators: Hashim Uddinn Ahmed, MD, University College London Hospitals

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Anticipated): July 1, 2011

Study Registration Dates

• First Submitted: September 30, 2009
• First Submitted That Met QC Criteria: September 30, 2009
• First Posted (Estimate): October 1, 2009

Study Record Updates

• Last Update Posted (Estimate): August 26, 2013
• Last Update Submitted That Met QC Criteria: August 23, 2013
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Keywords: stage III prostate cancer; stage I prostate cancer; stage IIB prostate cancer; stage IIA prostate cancer
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: CDR0000650138; UCLH-09-H0714-7