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The principal objective of this study is to demonstrate that patients can safely receive combined High Dose Rate brachytherapy and Intensity-Modulated Radiation Therapy without experiencing a treatment limiting toxicity.
Patients will receive a single High Dose Rate brachytherapy dose of 6 Gy to the prostate, followed by 61 Gy delivered to the prostate and nearby tissues using Intensity-Modulated Radiation Therapy in 28 treatments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HDR brachytherapy -> IMRT | Experimental | Radiotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| high dose-rate brachytherapy | Procedure | High dose-rate brachytherapy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To demonstrate that patients can safely receive combined HDR brachytherapy and IMRT teletherapy to a total dose consistent with current treatment policies and without experiencing a treatment limiting toxicity | 10 years |
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Inclusion Criteria:
Exclusion Criteria:
Patients at high risk for distant disease (PSA > 30 ng/ml, Gleason's sum > 8 or clinical stage > T2c), clinically involved seminal vesicles or extension beyond the prostate capsule history of inflammatory bowel disease require steroid or cytotoxic therapy for collagen vascular disease uncontrolled or poorly controlled hypertension uncontrolled or poorly controlled diabetes mellitus history of cancer other than skin cancer within five years of the initiation of protocol treatment history of pelvic irradiation require the routine use of warfarin
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| Name | Affiliation | Role |
|---|---|---|
| Michael P Hagan, MD, PhD | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University | Richmond | Virginia | 23298-0058 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12694839 | Background | Amer AM, Mott J, Mackay RI, Williams PC, Livsey J, Logue JP, Hendry JH. Prediction of the benefits from dose-escalated hypofractionated intensity-modulated radiotherapy for prostate cancer. Int J Radiat Oncol Biol Phys. 2003 May 1;56(1):199-207. doi: 10.1016/s0360-3016(03)00086-5. |
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| ID | Term |
|---|---|
| D050397 | Radiotherapy, Intensity-Modulated |
| ID | Term |
|---|---|
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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| intensity-modulated radiation therapy |
| Procedure |
intensity-modulated radiation therapy |
|