Using Ultrasound Spectrum Analysis (USA) to Guide Dose Escalated Prostate Brachytherapy
| Status: | Completed |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | February 2007 |
| End Date: | August 2014 |
Phase I/II Evaluation of Cancer-Specific Imaging Using Ultrasound Spectrum Analysis (USA) to Guide Dose Escalated Prostate Brachytherapy
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.
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.
Prostate brachytherapy is an increasingly popular treatment for clinically localized
prostate cancer.In properly selected patients, it is highly effective with biochemical (PSA)
disease free survival rates of 80-87% at 5-10 years.However, the technique is currently
limited by the inability to localize the cancer within the prostate. The multifocal nature
of prostate cancer is well established. Because of the inability to know where within the
prostate the cancer is located, radiation must be delivered throughout the gland. Although
this blind approach leads to good results, it is clear that there are regions of the
prostate and surrounding tissue that are overexposed to radiation while others are
underexposed relative to their true need based on their tumor burden and their proximity to
the tumor areas.Feleppa et al. at Riverside Research Institute (New York, NY), a non-profit
ultrasound research center, have developed an ultrasound-based technique to identify
cancer-containing areas within the prostate. This technique uses current ultrasound
equipment already in use for prostate brachytherapy guidance. By extracting and processing
the radiofrequency signal obtained from the ultrasound transducer in ways not done to create
the standard B-mode ultrasound image, areas of cancer can be identified and displayed
overlying the standard B-mode ultrasound image.In this study, we propose to obtain these
ultrasound-based cancer-specific images of the prostate prior to the brachytherapy and use
them to direct the dosimetry planning.The primary goal of this study is to demonstrate that
this imaging modality can be incorporated into the treatment planning process for
brachytherapy. Furthermore, we wish to demonstrate the improved dosimetry of the
cancer-identified regions while maintaining the urethral dose guidelines noted above. We
also wish to compare the differences in dose to the other adjacent normal structures
(anterior rectum and right and left neurovascular bundles). Additionally, we seek to
demonstrate, at a minimum, no increased toxicity with this approach and similar disease
control rates. Of course, ultimately the goal will be to demonstrate a superior therapeutic
ratio with this technique.
prostate cancer.In properly selected patients, it is highly effective with biochemical (PSA)
disease free survival rates of 80-87% at 5-10 years.However, the technique is currently
limited by the inability to localize the cancer within the prostate. The multifocal nature
of prostate cancer is well established. Because of the inability to know where within the
prostate the cancer is located, radiation must be delivered throughout the gland. Although
this blind approach leads to good results, it is clear that there are regions of the
prostate and surrounding tissue that are overexposed to radiation while others are
underexposed relative to their true need based on their tumor burden and their proximity to
the tumor areas.Feleppa et al. at Riverside Research Institute (New York, NY), a non-profit
ultrasound research center, have developed an ultrasound-based technique to identify
cancer-containing areas within the prostate. This technique uses current ultrasound
equipment already in use for prostate brachytherapy guidance. By extracting and processing
the radiofrequency signal obtained from the ultrasound transducer in ways not done to create
the standard B-mode ultrasound image, areas of cancer can be identified and displayed
overlying the standard B-mode ultrasound image.In this study, we propose to obtain these
ultrasound-based cancer-specific images of the prostate prior to the brachytherapy and use
them to direct the dosimetry planning.The primary goal of this study is to demonstrate that
this imaging modality can be incorporated into the treatment planning process for
brachytherapy. Furthermore, we wish to demonstrate the improved dosimetry of the
cancer-identified regions while maintaining the urethral dose guidelines noted above. We
also wish to compare the differences in dose to the other adjacent normal structures
(anterior rectum and right and left neurovascular bundles). Additionally, we seek to
demonstrate, at a minimum, no increased toxicity with this approach and similar disease
control rates. Of course, ultimately the goal will be to demonstrate a superior therapeutic
ratio with this technique.
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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