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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
questionnaire administration
high-intensity focused ultrasound ablation
quality-of-life assessment
Sponsored by
University College London Hospitals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer

Eligibility Criteria

undefined - 79 Years (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • University College of London Hospitals

Outcomes

Primary Outcome Measures

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 Outcome Measures

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

Full Information

First Posted
November 17, 2007
Last Updated
August 23, 2013
Sponsor
University College London Hospitals
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1. Study Identification

Unique Protocol Identification Number
NCT00561262
Brief Title
High-Intensity Focused Ultrasound Therapy in Treating Patients With Localized Prostate Cancer
Official Title
An Evaluation of Hemi-ablation Therapy Using High-Intensity Focused Ultrasound in the Treatment of Localized Adenocarcinoma of the Prostate
Study Type
Interventional

2. Study Status

Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University College London Hospitals

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
adenocarcinoma of the prostate, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
questionnaire administration
Intervention Type
Procedure
Intervention Name(s)
high-intensity focused ultrasound ablation
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Primary Outcome Measure Information:
Title
Feasibility
Title
Adverse events
Title
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
Title
Side effect profile
Secondary Outcome Measure Information:
Title
Measurement of prostate-specific antigen (PSA) kinetics including time to PSA nadir
Title
Exclusion of cancer on MRI at 2-7 days and at 6 months
Title
Transrectal ultrasound biopsies at 6 months
Title
Need for secondary or adjuvant treatment for prostate cancer following therapy

10. Eligibility

Sex
Male
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Emberton, MD, FRCS, MBBS
Organizational Affiliation
University College London Hospitals
Official's Role
Study Chair
Facility Information:
Facility Name
University College of London Hospitals
City
London
State/Province
England
ZIP/Postal Code
WIT 3AA
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
21334018
Citation
Ahmed HU, Freeman A, Kirkham A, Sahu M, Scott R, Allen C, Van der Meulen J, Emberton M. Focal therapy for localized prostate cancer: a phase I/II trial. J Urol. 2011 Apr;185(4):1246-54. doi: 10.1016/j.juro.2010.11.079. Epub 2011 Feb 22.
Results Reference
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High-Intensity Focused Ultrasound Therapy in Treating Patients With Localized Prostate Cancer

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