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

Primary Purpose

Prostate Cancer

Status
Unknown status
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
pharmacological study
questionnaire administration
assessment of therapy complications
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 stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer

Eligibility Criteria

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

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

Sites / Locations

  • University College HospitalRecruiting

Outcomes

Primary Outcome Measures

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

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

Full Information

First Posted
September 30, 2009
Last Updated
August 23, 2013
Sponsor
University College London Hospitals
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1. Study Identification

Unique Protocol Identification Number
NCT00987675
Brief Title
High-Intensity Focused Ultrasound Ablation in Treating Patients With Progressive Prostate Cancer
Official Title
An Evaluation of Lesion Control Using Focal Ablation With High Intensity Focused Ultrasound in the Treatment of Non-Metastatic Progressive Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Unknown status
Study Start Date
July 2009 (undefined)
Primary Completion Date
July 2011 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University College London Hospitals

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
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
26 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
pharmacological study
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Intervention Type
Procedure
Intervention Name(s)
assessment of therapy complications
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
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 Measure Information:
Title
Success of treatment as demonstrated by the absence of cancer at 6 months
Title
PSA kinetics after completion of treatment
Title
Proportion of patients requiring androgen blockade at 12 months

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hashim Uddinn Ahmed, MD
Organizational Affiliation
University College London Hospitals
Facility Information:
Facility Name
University College Hospital
City
London
State/Province
England
ZIP/Postal Code
WIT 3AA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hashim Uddinn Ahmed, MD
Phone
44-20-7380-9194

12. IPD Sharing Statement

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

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