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The purpose of this study is to find out the effects (good and bad) of using newer technologies that allow very precise delivery of radiation. These newer technologies are Intensity Modulated Radiation Therapy (IMRT) and Image Guided Radiation Therapy (IGRT).
In this study the treating physicians will deliver a high dose of radiation to pelvic lymph nodes of 56 Gy (Gy/Gray = measure of amount of radiation) and at the same time give a boost (additional) radiation to the prostate itself (to 70 Gy). The study will evaluate the response of the cancer and side effects of radiation to pelvic lymph nodes and to the prostate.
It is hoped that these newer technologies will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMRT & IGRT Radiation Therapy | Experimental | In this study we will deliver a high dose of radiation to the pelvic lymph nodes of 56 Gy (Gy/Gray = measure of amount of radiation) and at the same time give a boost (additional) radiation to the prostate itself (to 70 Gy). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiation Therapy | Radiation | A high dose of radiation to the pelvic lymph nodes of 56 Gy (Gy/Gray = measure of amount of radiation) and at the same time give a boost (additional) radiation to the prostate itself (to 70 Gy). |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline PSA level | PSA level in blood is measured in units of nanograms per milliliter. | 4 months |
| Change from baseline PSA level | PSA level in blood is measured in units of nanograms per milliliter. | 7 months |
| Change from baseline PSA level | PSA level in blood is measured in units of nanograms per milliliter. | 10 months |
| Change from baseline PSA level | PSA level in blood is measured in units of nanograms per milliliter. | 13 months |
| Change from baseline PSA level | PSA level in blood is measured in units of nanograms per milliliter. | 16 months |
| Change from baseline PSA level | PSA level in blood is measured in units of nanograms per milliliter. | 19 months |
| Change from baseline PSA level | PSA level in blood is measured in units of nanograms per milliliter. | 22 months |
| Change from baseline PSA level | PSA level in blood is measured in units of nanograms per milliliter. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William Hall, MD | Medical College of Wisconsin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Froedtert & the Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17544601 | Background | Kupelian PA, Willoughby TR, Reddy CA, Klein EA, Mahadevan A. Hypofractionated intensity-modulated radiotherapy (70 Gy at 2.5 Gy per fraction) for localized prostate cancer: Cleveland Clinic experience. Int J Radiat Oncol Biol Phys. 2007 Aug 1;68(5):1424-30. doi: 10.1016/j.ijrobp.2007.01.067. Epub 2007 Jun 4. |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D050397 | Radiotherapy, Intensity-Modulated |
| D061089 | Radiotherapy, Image-Guided |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
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|
| 25 months |
| Change from baseline PSA level | PSA level in blood is measured in units of nanograms per milliliter. | 31 months |
| Change from baseline PSA level | PSA level in blood is measured in units of nanograms per milliliter. | 37 months |
| Change from baseline PSA level | PSA level in blood is measured in units of nanograms per milliliter. | 43 months |
| Change from baseline PSA level | PSA level in blood is measured in units of nanograms per milliliter. | 49 months |
| Change from baseline PSA level | PSA level in blood is measured in units of nanograms per milliliter. | 55 months |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |