- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00988130
High-Intensity Focused Ultrasound Focal Ablation in Treating Patients With Progressive Prostate Cancer
HIFU Lesion Control in Patients With Non-metastatic Progressive Prostate Cancer
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.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
England
-
London, England, United Kingdom, WIT 3AA
- Recruiting
- University College Hospital - London
-
Contact:
- Mark Emberton, MD, FRCS, MBBS
- Phone Number: 44-20-7380-9194
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Quality of life
|
Total proportion of men with erectile dysfunction and/or incontinence
|
Secondary Outcome Measures
Outcome Measure |
---|
Success of index lesion ablation with HIFU at 6 months
|
Prostate-specific antigen kinetics
|
Proportion of men requiring androgen blockade at 12 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Mark Emberton, MD, FRCS, MBBS, University College London Hospitals
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000652331
- UCL-09-H0714-7
- EU-20977
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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