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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00988130 |
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Date of registration:
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30/09/2009 |
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Primary sponsor: |
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Public title:
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High-Intensity Focused Ultrasound Focal Ablation in Treating Patients With Progressive Prostate Cancer
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Scientific title:
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HIFU Lesion Control in Patients With Non-metastatic Progressive Prostate Cancer |
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Date of first enrolment:
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July 2009 |
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Target sample size:
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26 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00988130 |
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Study type:
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Interventional |
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Study design:
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Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Mark Emberton, MD, FRCS, MBBS |
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Address:
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Telephone:
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44-20-7380-9194 |
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Email:
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Affiliation:
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Name:
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Mark Emberton, MD, FRCS, MBBS |
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Address:
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Telephone:
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Email:
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Affiliation:
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University College London Hospitals |
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Key inclusion & exclusion criteria
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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
Age minimum:
N/A
Age maximum:
N/A
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Prostate Cancer
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Sexual Dysfunction
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Intervention(s)
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Other: laboratory biomarker analysis
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Other: questionnaire administration
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Procedure: assessment of therapy complications
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Procedure: high-intensity focused ultrasound ablation
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Procedure: quality-of-life assessment
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Primary Outcome(s)
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Quality of life
[Time Frame: No]
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Total proportion of men with erectile dysfunction and/or incontinence
[Time Frame: Yes]
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Secondary Outcome(s)
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Proportion of men requiring androgen blockade at 12 months
[Time Frame: No]
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Prostate-specific antigen kinetics
[Time Frame: No]
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Success of index lesion ablation with HIFU at 6 months
[Time Frame: No]
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Secondary ID(s)
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CDR0000652331
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EU-20977
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UCL-09-H0714-7
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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