Using Magnetic Resonance Imaging (MRI) to Guide Differential-Dose Prostate Brachytherapy
| Status: | Terminated |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/7/2017 |
| Start Date: | August 2013 |
| End Date: | November 2016 |
Phase I/II Evaluation Magnetic Resonance Imaging (MRI)-Guided Differential-Dose Prostate Brachytherapy
In standard prostate brachytherapy treatment, the seeds are placed throughout the prostate
to treat the entire gland. This is done because, in the past, it was impossible to know
where the cancer was located within the prostate. Multiparametric magnetic resonance imaging
(MRI) can identify tumor(s) with a high degree of accuracy. This trial will assess whether
using MRI to guide prostate brachytherapy can result in less chronic toxicity by allowing
lower doses to be delivered to the regions of the prostate without tumor while
simultaneously allowing higher doses to the tumor. Subjects enrolled in this study will then
be followed over two years and evaluated for toxicity. In addition, after two years they
will undergo an MRI and a biopsy to assess the cancer control rate of the treatment.
to treat the entire gland. This is done because, in the past, it was impossible to know
where the cancer was located within the prostate. Multiparametric magnetic resonance imaging
(MRI) can identify tumor(s) with a high degree of accuracy. This trial will assess whether
using MRI to guide prostate brachytherapy can result in less chronic toxicity by allowing
lower doses to be delivered to the regions of the prostate without tumor while
simultaneously allowing higher doses to the tumor. Subjects enrolled in this study will then
be followed over two years and evaluated for toxicity. In addition, after two years they
will undergo an MRI and a biopsy to assess the cancer control rate of the treatment.
Prostate brachytherapy is a popular treatment for clinically localized prostate cancer. In
properly selected patients, it is highly effective with biochemical (PSA) disease free
survival rates of 85-95% 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.
Multiple studies have shown significant correlation between MRI abnormalities and radical
prostatectomy specimens for determining size and location of cancer foci. MRI images have
already begun to be incorporated into diagnostic and therapeutic procedures for prostate
cancer on an experimental basis by other investigators. The images have been fused with real
time TRUS to successfully perform targeted biopsies. In this study, we propose to use MRI
images in the pre-treatment planning process to identify the tumors within the prostate
prior to the brachytherapy and use these images to direct the dosimetry planning. The
primary goal of this study is to decrease the chronic toxicities as assessed by the Common
Toxicity Criteria Version 4.0 by decreasing the integral dose to the regions of the prostate
which do not have tumor. A secondary goal is to increase the dose to the tumor(s) and
demonstrate this ability while maintaining the urethral and other normal tissue doses. We
also wish to perform dosimetric comparisons of the normal tissues and the tumor(s) when this
technique is used compared to what would have been done if the patient had received a
traditional implant. Finally, we propose to perform a prostate MRI followed by a biopsy to
evaluate for persistent/recurrent disease at 2 years after treatment.
properly selected patients, it is highly effective with biochemical (PSA) disease free
survival rates of 85-95% 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.
Multiple studies have shown significant correlation between MRI abnormalities and radical
prostatectomy specimens for determining size and location of cancer foci. MRI images have
already begun to be incorporated into diagnostic and therapeutic procedures for prostate
cancer on an experimental basis by other investigators. The images have been fused with real
time TRUS to successfully perform targeted biopsies. In this study, we propose to use MRI
images in the pre-treatment planning process to identify the tumors within the prostate
prior to the brachytherapy and use these images to direct the dosimetry planning. The
primary goal of this study is to decrease the chronic toxicities as assessed by the Common
Toxicity Criteria Version 4.0 by decreasing the integral dose to the regions of the prostate
which do not have tumor. A secondary goal is to increase the dose to the tumor(s) and
demonstrate this ability while maintaining the urethral and other normal tissue doses. We
also wish to perform dosimetric comparisons of the normal tissues and the tumor(s) when this
technique is used compared to what would have been done if the patient had received a
traditional implant. Finally, we propose to perform a prostate MRI followed by a biopsy to
evaluate for persistent/recurrent disease at 2 years after treatment.
Inclusion Criteria:
- Clinical stage ≤ T2b according to the American Joint Commission on Cancer 6th
Edition28
- PSA ≤ 15 ng/ml
- Gleason sum on biopsy ≤ 6 or 3+4=7
- Prostate volume ≤ 60 cc
- Willing to continue follow-up for at least two years
Exclusion Criteria:
- Prior hormone therapy
- Prior radiotherapy
- History of collagen vascular disease
- History of inflammatory bowel disease
We found this trial at
1
site
New York, New York 10025
Principal Investigator: Ronald Ennis, MD
Phone: 212-523-7901
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