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

Primary Purpose

Prostate Cancer, Sexual Dysfunction

Status
Unknown status
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
laboratory biomarker analysis
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 sexual dysfunction, 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 by transrectal or transperineal template prostate biopsies

    • Stage ≤ T3bN0M0
    • Gleason grade ≤ 8
    • Serum PSA ≤ 20 ng/mL
    • Bone scan- or cross-sectional imaging-negative for metastatic or nodal (outside prostate) disease
    • No metastatic disease and/or nodal spread by CT scan or MRI
  • Index lesion or other secondary lesions with a volume ≥ 0.5 cc by MRI
  • No prostatic calcification and cysts (on transrectal ultrasound) that would interfere with effective delivery of therapy

PATIENT CHARACTERISTICS:

  • Able to tolerate a transrectal ultrasound
  • Not allergic to latex
  • Fit for major surgery as assessed by a consultant anaesthetist
  • Able to have MRI scanning (i.e., none of the following conditions: severe claustrophobia, permanent cardiac pacemaker, metallic implant, etc.)

PRIOR CONCURRENT THERAPY:

  • No prior radiotherapy
  • No androgen suppression and/or hormone treatment within the past 12 months
  • No prior significant rectal surgery preventing insertion of transrectal high-intensity focused ultrasound (HIFU) probe (decided on the type of surgery in individual cases)
  • No prior transurethral resection of the prostate (or equivalent procedures) within the past 2 years
  • No prior HIFU, cryosurgery, thermal, or microwave therapy to the prostate

Sites / Locations

  • University College Hospital - LondonRecruiting

Outcomes

Primary Outcome Measures

Total proportion of men with erectile dysfunction and/or incontinence
Quality of life

Secondary Outcome Measures

Success of index lesion ablation with HIFU at 6 months
Prostate-specific antigen kinetics
Proportion of men 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
NCT00988130
Brief Title
High-Intensity Focused Ultrasound Focal Ablation in Treating Patients With Progressive Prostate Cancer
Official Title
HIFU Lesion Control in Patients With Non-metastatic Progressive Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Unknown status
Study Start Date
July 2009 (undefined)
Primary Completion Date
undefined (undefined)
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 focal 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 focal ablation and to see how well it works in treating patients with progressive prostate cancer.
Detailed Description
OBJECTIVES: Primary To evaluate the side effects of high-intensity focused ultrasound (HIFU) ablation in men with non-metastatic progressive prostate cancer. To evaluate the quality of life of patients treated with this regimen. Secondary To determine the success of index lesion ablation with HIFU at 6 months after treatment by demonstrating the absence of cancer in the treated or ablated area by transrectal ultrasound biopsy. To evaluate the prostate-specific antigen kinetics after index lesion ablation in patients treated with this regimen. To evaluate the proportion of men who require androgen blockade at 12 months of follow-up. OUTLINE: Patients undergo focal ablation with high-intensity focused ultrasound (HIFU) ablation on day 1. Treatment may repeat at 6 months in patients with progressive disease. Blood samples and prostate biopsies are collected periodically for further analysis. Patients complete questionnaires (IPSS, IPSS-QoL, ICS, IIEF-5, and FACT-P) at baseline and periodically during study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Sexual Dysfunction
Keywords
sexual dysfunction, 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
Masking
None (Open Label)
Enrollment
26 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
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
Total proportion of men with erectile dysfunction and/or incontinence
Title
Quality of life
Secondary Outcome Measure Information:
Title
Success of index lesion ablation with HIFU at 6 months
Title
Prostate-specific antigen kinetics
Title
Proportion of men requiring androgen blockade at 12 months

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed prostate cancer by transrectal or transperineal template prostate biopsies Stage ≤ T3bN0M0 Gleason grade ≤ 8 Serum PSA ≤ 20 ng/mL Bone scan- or cross-sectional imaging-negative for metastatic or nodal (outside prostate) disease No metastatic disease and/or nodal spread by CT scan or MRI Index lesion or other secondary lesions with a volume ≥ 0.5 cc by MRI No prostatic calcification and cysts (on transrectal ultrasound) that would interfere with effective delivery of therapy PATIENT CHARACTERISTICS: Able to tolerate a transrectal ultrasound Not allergic to latex Fit for major surgery as assessed by a consultant anaesthetist Able to have MRI scanning (i.e., none of the following conditions: severe claustrophobia, permanent cardiac pacemaker, metallic implant, etc.) PRIOR CONCURRENT THERAPY: No prior radiotherapy No androgen suppression and/or hormone treatment within the past 12 months No prior significant rectal surgery preventing insertion of transrectal high-intensity focused ultrasound (HIFU) probe (decided on the type of surgery in individual cases) No prior transurethral resection of the prostate (or equivalent procedures) within the past 2 years No prior HIFU, 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
Principal Investigator
Facility Information:
Facility Name
University College Hospital - London
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
Mark Emberton, MD, FRCS, MBBS
Phone
44-20-7380-9194

12. IPD Sharing Statement

Citations:
PubMed Identifier
25682339
Citation
Ahmed HU, Dickinson L, Charman S, Weir S, McCartan N, Hindley RG, Freeman A, Kirkham AP, Sahu M, Scott R, Allen C, Van der Meulen J, Emberton M. Focal Ablation Targeted to the Index Lesion in Multifocal Localised Prostate Cancer: a Prospective Development Study. Eur Urol. 2015 Dec;68(6):927-36. doi: 10.1016/j.eururo.2015.01.030. Epub 2015 Feb 11.
Results Reference
derived

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

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