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

Primary Purpose

Prostate Cancer, Sexual Dysfunction, Urinary Incontinence

Status

Completed

Phase

Phase 2

Locations

United Kingdom

Study Type

Interventional

Intervention

questionnaire administration

biopsy

high-intensity focused ultrasound ablation

magnetic resonance imaging

quality-of-life assessment

About this trial

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

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

Histologically confirmed adenocarcinoma of the prostate
- Low-risk disease, as defined by the following criteria:
  - Gleason grade total ≤ 7 (patterns 3+4 or 4+3 or less acceptable)
  - Localized disease (unilateral or bilateral) (stage T2c, N0, M0 or less)
  - Serum PSA ≤ 15 ng/mL
Prostate volume ≤ 40 cc or maximum anterior-posterior length ≤ 40 mm
Multi-sequence-MRI and transperineal template 5 mm-spaced biopsies performed within the past 6 months
All malignant areas must be treatable by focal ablation so that approximately 50% of prostate tissue is destroyed and ≥ 1 neurovascular bundle is preserved
No intraprostatic calcifications making high-intensity focused ultrasound of focal areas of cancer untreatable
No metastatic disease

PATIENT CHARACTERISTICS:

Life expectancy ≥ 5 years
Must be fit for general or regional anesthesia as assessed by Consultant Anesthetist
No prior rectal fistula
No American Society of Anesthesiology grades III-IV
No latex allergies
No contraindication to MRI scanning (e.g., severe claustrophobia, permanent cardiac pacemaker, or metallic implant likely to contribute significant artifact to images)
No moderate to severe inflammatory bowel disease

PRIOR CONCURRENT THERAPY:

No androgen suppression treatment within the past 6 months
No transurethral resection of the prostate or laser prostatectomy within the past 5 years
No prior treatment (i.e., radiotherapy, brachytherapy, surgery, laser therapy, chemotherapy, high-intensity focused ultrasound, cryosurgery, thermal therapy, or microwave therapy) for prostate cancer
No prior significant rectal surgery preventing insertion of transrectal probe

Sites / Locations

Basingstoke and North Hampshire NHS Foundation Trust
University College of London Hospitals

Outcomes

Primary Outcome Measures

Feasibility, patient acceptability and side effect profile of high-intensity focal ultrasound ablation as determined by adverse events

Patient acceptability, urinary symptoms, and erectile function as assessed by Functional Assessment of Cancer Treatment-Prostate (FACT-P); Item International Index of Erectile Dysfunction (IIEF-15); International Prostate Symptom Score (IPSS); I ...

Secondary Outcome Measures

Effectiveness of high-intensity focal ultrasound ablation to control prostate cancer as determined by time to PSA nadir, MRI at 10-20 days and again at 6 months, biopsies of treated areas at 6 months, and by recording the need for secondary or adjuva ...

Full Information

NCT ID

NCT00561314

First Posted

November 17, 2007

Last Updated

August 23, 2013

Sponsor

University College London Hospitals

1. Study Identification

Unique Protocol Identification Number

NCT00561314

Brief Title

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

Official Title

An Evaluation of Focal 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

July 2009

Overall Recruitment Status

Completed

Study Start Date

July 2007 (undefined)

Primary Completion Date

February 2009 (Actual)

Study Completion Date

January 2012 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University College London Hospitals

4. Oversight

5. Study Description

Brief Summary

RATIONALE: Highly focused ultrasound energy may be able to kill tumor cells by heating the tumor without affecting the surrounding tissue. PURPOSE: This phase II trial is studying the side effects and how well highly focused ultrasound energy works in treating patients with localized prostate cancer.

Detailed Description

OBJECTIVES: Primary To evaluate feasibility, side effect profile, and patient acceptability of high-intensity focused ultrasound ablation in patients with organ-confined, MRI and histologically proven adenocarcinoma of the prostate. Secondary To determine the effectiveness of therapy via biopsy, MRI, PSA level and estimated time to PSA nadir, and by recording the need for secondary or adjuvant treatment following therapy. OUTLINE: A probe is inserted into the rectum. High-intensity focused ultrasound (HIFU) energy using the Sonablate system is delivered to the prostate tissue over approximately 2 hours. Patients are then evaluated over a 12-month period. Patients undergo multi-sequence MRI within 10-20 days after HIFU to assess the extent and volume of tumor necrosis and again at 6 months to assess for disease recurrence. Blood is collected for PSA levels at baseline and then at 1, 3, 6, 9, and 12 months. Patients also undergo transrectal ultrasound biopsy at 6 months to evaluate disease response. Patients complete questionnaires at baseline and at 1, 3, 6, 9, and 12 months to evaluate erectile and sexual function, urinary flow and continence, and quality-of-life.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer, Sexual Dysfunction, Urinary Incontinence

Keywords

sexual dysfunction, urinary incontinence, adenocarcinoma of the prostate, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Enrollment

33 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Other

Intervention Name(s)

questionnaire administration

Intervention Type

Procedure

Intervention Name(s)

biopsy

Intervention Type

Procedure

Intervention Name(s)

high-intensity focused ultrasound ablation

Intervention Type

Procedure

Intervention Name(s)

magnetic resonance imaging

Intervention Type

Procedure

Intervention Name(s)

quality-of-life assessment

Primary Outcome Measure Information:

Title

Feasibility, patient acceptability and side effect profile of high-intensity focal ultrasound ablation as determined by adverse events

Title

Secondary Outcome Measure Information:

Title

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate Low-risk disease, as defined by the following criteria: Gleason grade total ≤ 7 (patterns 3+4 or 4+3 or less acceptable) Localized disease (unilateral or bilateral) (stage T2c, N0, M0 or less) Serum PSA ≤ 15 ng/mL Prostate volume ≤ 40 cc or maximum anterior-posterior length ≤ 40 mm Multi-sequence-MRI and transperineal template 5 mm-spaced biopsies performed within the past 6 months All malignant areas must be treatable by focal ablation so that approximately 50% of prostate tissue is destroyed and ≥ 1 neurovascular bundle is preserved No intraprostatic calcifications making high-intensity focused ultrasound of focal areas of cancer untreatable No metastatic disease PATIENT CHARACTERISTICS: Life expectancy ≥ 5 years Must be fit for general or regional anesthesia as assessed by Consultant Anesthetist No prior rectal fistula No American Society of Anesthesiology grades III-IV No latex allergies No contraindication to MRI scanning (e.g., severe claustrophobia, permanent cardiac pacemaker, or metallic implant likely to contribute significant artifact to images) No moderate to severe inflammatory bowel disease PRIOR CONCURRENT THERAPY: No androgen suppression treatment within the past 6 months No transurethral resection of the prostate or laser prostatectomy within the past 5 years No prior treatment (i.e., radiotherapy, brachytherapy, surgery, laser therapy, chemotherapy, high-intensity focused ultrasound, cryosurgery, thermal therapy, or microwave therapy) for prostate cancer No prior significant rectal surgery preventing insertion of transrectal probe

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

Basingstoke and North Hampshire NHS Foundation Trust

City

Basingstoke

State/Province

England

ZIP/Postal Code

RG24 9NA

Country

United Kingdom

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

22512844

Citation

Ahmed HU, Hindley RG, Dickinson L, Freeman A, Kirkham AP, Sahu M, Scott R, Allen C, Van der Meulen J, Emberton M. Focal therapy for localised unifocal and multifocal prostate cancer: a prospective development study. Lancet Oncol. 2012 Jun;13(6):622-32. doi: 10.1016/S1470-2045(12)70121-3. Epub 2012 Apr 17.

Results Reference

result

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

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