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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00561262
First received: November 17, 2007
Last updated: August 23, 2013
Last verified: June 2009
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Other: questionnaire administration
Procedure: high-intensity focused ultrasound ablation
Procedure: quality-of-life assessment
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: An Evaluation of Hemi-ablation Therapy Using High-Intensity Focused Ultrasound in the Treatment of Localized Adenocarcinoma of the Prostate

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Feasibility [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: Yes ]
  • 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 [ Designated as safety issue: No ]
  • Side effect profile [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Measurement of prostate-specific antigen (PSA) kinetics including time to PSA nadir [ Designated as safety issue: No ]
  • Exclusion of cancer on MRI at 2-7 days and at 6 months [ Designated as safety issue: No ]
  • Transrectal ultrasound biopsies at 6 months [ Designated as safety issue: No ]
  • Need for secondary or adjuvant treatment for prostate cancer following therapy [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: May 2006
Study Completion Date: April 2011
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Detailed Description:

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

Ages Eligible for Study:   up to 79 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00561262

Locations
United Kingdom
University College of London Hospitals
London, England, United Kingdom, WIT 3AA
Sponsors and Collaborators
University College London Hospitals
Investigators
Study Chair: Mark Emberton, MD, FRCS, MBBS University College London Hospitals
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00561262     History of Changes
Other Study ID Numbers: CDR0000574367, UCLCTC-UCLH-HEMI-HIFU, EU-20774, ISRCTN25145525
Study First Received: November 17, 2007
Last Updated: August 23, 2013
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the prostate
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 20, 2014