Prostate Cancer Clinical Trial
Official title:
An Evaluation of Lesion Control Using Focal Ablation With High Intensity Focused Ultrasound in the Treatment of Non-Metastatic Progressive Prostate Cancer
Verified date | March 2011 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | Unspecified |
Study type | Interventional |
RATIONALE: High-intensity focused ultrasound 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 ablation and to see how well it works in treating patients with progressive
prostate cancer.
Status | Recruiting |
Enrollment | 26 |
Est. completion date | |
Est. primary completion date | July 2011 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | N/A and older |
Eligibility |
DISEASE CHARACTERISTICS: - Histologically confirmed prostate cancer on transrectal ultrasound or transperineal template prostate biopsies meeting the following criteria: - Stage = T3b, N0, M0 disease - Gleason score = 8 - Serum PSA = 20 ng/mL - No metastatic disease and nodal spread by staging CT or MRI - Negative bone scan within the past 6 months - Index lesion or other secondary lesions with a volume of = 0.5 cc by MRI - Secondary lesions are included in the treatment provided = 1 neurovascular bundle and 40-50% of prostatic tissue can be preserved PATIENT CHARACTERISTICS: - Able to tolerate a transrectal ultrasound - Able to undergo major surgery as assessed by a consultant anesthesiologist - Able to undergo MRI scanning (i.e., no severe claustrophobia, permanent cardiac pacemaker, metallic implant) - No urethral stricture or presence of metal implants or stents in the urethra - No prostatic calcification or cysts (on transrectal ultrasound) that would interfere with effective delivery of HIFU therapy - No allergy to latex PRIOR CONCURRENT THERAPY: - No prior radiotherapy - No prior treatment with any of the following: - Transurethral resection of the prostate or equivalent procedures within the past 2 years - High-intensity focused ultrasound ablation (HIFU) - Cryosurgery - Thermal or microwave therapy to the prostate - No prior significant rectal surgery that prevents insertion of the transrectal HIFU probe - More than 12 months since prior androgen suppression or hormone treatment for prostate cancer |
Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | University College Hospital | London | England |
Lead Sponsor | Collaborator |
---|---|
University College London Hospitals |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Side effects and patient-reported quality of life after treatment as measured by IPSS, IPSS-QOL, ICS, FACT-P, and IIEF-5 questionnaires at baseline, 6 weeks, and 3, 6, 9 and 12 months | No | ||
Secondary | Success of treatment as demonstrated by the absence of cancer at 6 months | No | ||
Secondary | PSA kinetics after completion of treatment | No | ||
Secondary | Proportion of patients requiring androgen blockade at 12 months | No |
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