High-Intensity Focused Ultrasound Focal Ablation in Treating Patients With Progressive Prostate Cancer
NCT ID: NCT00988130
Last Updated: 2013-08-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
26 participants
INTERVENTIONAL
2009-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
TREATMENT
NONE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
laboratory biomarker analysis
questionnaire administration
assessment of therapy complications
high-intensity focused ultrasound ablation
quality-of-life assessment
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University College London Hospitals
OTHER
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Mark Emberton, MD, FRCS, MBBS
Role: PRINCIPAL_INVESTIGATOR
University College London Hospitals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University College Hospital - London
London, England, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Mark Emberton, MD, FRCS, MBBS
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
UCL-09-H0714-7
Identifier Type: -
Identifier Source: secondary_id
EU-20977
Identifier Type: -
Identifier Source: secondary_id
CDR0000652331
Identifier Type: -
Identifier Source: org_study_id