High-Intensity Focused Ultrasound Focal Ablation in Treating Patients With Progressive Prostate Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by National Cancer Institute (NCI).
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University College London Hospitals
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00988130
First received: September 30, 2009
Last updated: February 19, 2012
Last verified: May 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer Sexual Dysfunction |
Other: laboratory biomarker analysis Other: questionnaire administration Procedure: assessment of therapy complications Procedure: high-intensity focused ultrasound ablation Procedure: quality-of-life assessment |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | HIFU Lesion Control in Patients With Non-metastatic Progressive Prostate Cancer |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Total proportion of men with erectile dysfunction and/or incontinence [ Designated as safety issue: Yes ]
- Quality of life [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Success of index lesion ablation with HIFU at 6 months [ Designated as safety issue: No ]
- Prostate-specific antigen kinetics [ Designated as safety issue: No ]
- Proportion of men requiring androgen blockade at 12 months [ Designated as safety issue: No ]
| Estimated Enrollment: | 26 |
| Study Start Date: | July 2009 |
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.
Eligibility| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00988130
Locations
| United Kingdom | |
| University College Hospital - London | Recruiting |
| London, England, United Kingdom, WIT 3AA | |
| Contact: Mark Emberton, MD, FRCS, MBBS 44-20-7380-9194 | |
Sponsors and Collaborators
University College London Hospitals
Investigators
| Principal Investigator: | Mark Emberton, MD, FRCS, MBBS | University College London Hospitals |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00988130 History of Changes |
| Other Study ID Numbers: | CDR0000652331, UCL-09-H0714-7, EU-20977 |
| Study First Received: | September 30, 2009 |
| Last Updated: | February 19, 2012 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
sexual dysfunction stage I prostate cancer stage IIB prostate cancer stage IIA prostate cancer stage III prostate cancer |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Sexual Dysfunctions, Psychological Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases Sexual and Gender Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 16, 2013