Status:
UNKNOWN
High-Intensity Focused Ultrasound Ablation in Treating Patients With Progressive Prostate Cancer
Lead Sponsor:
University College London Hospitals
Conditions:
Prostate Cancer
Eligibility:
MALE
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
OBJECTIVES: Primary * To evaluate the side effects and patient-reported quality of life outcomes of the index (largest) lesion treatment with high-intensity focused ultrasound ablation in patients w...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00987675
Start Date
July 1 2009
Last Update
August 26 2013
Active Locations (1)
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1
University College Hospital
London, England, United Kingdom, WIT 3AA