Status:
UNKNOWN
High-Intensity Focused Ultrasound Focal Ablation in Treating Patients With Progressive Prostate Cancer
Lead Sponsor:
University College London Hospitals
Conditions:
Prostate Cancer
Sexual Dysfunction
Eligibility:
MALE
Phase:
PHASE2
Brief Summary
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 ultra...
Detailed Description
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 p...
Eligibility Criteria
Inclusion
- 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
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
NCT00988130
Start Date
July 1 2009
Last Update
August 26 2013
Active Locations (1)
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1
University College Hospital - London
London, England, United Kingdom, WIT 3AA