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Study ID
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06-147
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Investigator
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Ronald Ennis, MD, St. Luke's-Roosevelt Hospital Center
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Title
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Using Ultrasound Spectrum Analysis (USA) to Guide Dose Escalated Prostate Brachytherapy
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Conditions
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Clinical Stage T2b or Less of Prostate Cancer
Prostate Brachytherapy
Transrectal Prostate Ultrasound Treatment Planning
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Interventions
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Other: An ultrasound-based technique to identify prostate cancer
Other: pre-implant transrectal ultrasound images and planning
Other: ultrasound-based cancer-specific images
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Phase
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Phase 1/Phase 2
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Purpose
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In standard treatment, the seeds are placed throughout the prostate to treat the entire
prostate. This is done because it was impossible to know where the cancer was located
within the prostate. A new technique has been developed using the same ultrasound imaging
that you probably had when you had your biopsy. Using this technique, areas likely to
contain prostate cancer can be identified.In this early study of 15 subjects, we will test
if this method to plan your prostate seed implant is safe and can be done as part of regular
care. Areas identified as suspicious for cancer will be treated with higher doses of
radiation while those areas not demonstrating cancer will be treated to the standard minimum
dose. The higher dose areas will receive two times the minimum dose the prostate usually
receives. Because this technique is not perfect, those areas not identified as cancerous
should be treated in case there is a cancer area that the technique did not identify.
Subjects enrolled in this study will then be followed with this ultrasound technique over
the next two years to monitor the changes to the cancerous areas and will undergo a biopsy
two years after the procedure. Subjects will, of course, be monitored to assess the success
of the technique and its side effects.
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Eligibility
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Ages Eligible: 18 Years
Genders Eligible:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:- Clinical stage ≤ T2b according to the American Joint Commission on Cancer 6th
Edition28
- PSA ≤ 10 ng/ml
- Gleason sum on biopsy ≤ 6
- Prostate volume ≤ 50 cc
- Willing to continue follow-up for at least two years.
Exclusion Criteria:- No prior hormone therapy
- No prior radiotherapy
- No history of collagen vascular disease
- No history of inflammatory bowel disease
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Study Location
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N/A
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Contact
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N/A
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Information obtained from ClinicalTrials.gov, on
5/23/2013. For additional information about
this and other clinical trials,
visit http://clinicaltrials.gov.
Please refer to this study by its ClinicalTrials.gov identifier:
NCT01227642