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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA022453 | U.S. NIH Grant/Contract | View source | |
| WSU-D-2879 | |||
| WSU-HIC-047405MP4F |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells. It is not yet known which type of radiation therapy is more effective in treating prostate cancer.
PURPOSE: This randomized phase III trial is studying different types of radiation therapy to compare how well they work in treating patients with stage I, stage II, or stage III prostate cancer.
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to stage of disease (T1 vs T2 vs T3). Patients are randomized to 1 of 2 treatment arms.
After completion of study treatment, patients are followed periodically for 5 years and then yearly thereafter.
PROJECTED ACCRUAL: A total of 300 patients (150 per treatment arm) will be accrued for this study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| radiation therapy | Radiation |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of chronic grade 2 or higher toxicity as measured by RTOG/EORTC late morbidity scoring scheme at 1, 4, 8, and 12 months after treatment, then every 6 months for 5 years, then annually |
| Measure | Description | Time Frame |
|---|---|---|
| Disease free survival at 1, 4, 8, and 12 months after treatment, then every 6 months for 5 years, then annually |
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DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate
Stage I-III disease (T1-T3, N0, M0)
No clinical or radiographic evidence of metastasis
PSA ≤ 20 ng/mL
Gleason score ≤ 7 (if stage T3 , score must be < 7)
PATIENT CHARACTERISTICS:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Endocrine therapy
Prior hormonal therapy allowed provided it was initiated no more than 2 months ago, and may include the following:
Radiotherapy
Surgery
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey D. Forman, MD, FACR | Weisberg Cancer Treatment Center | Study Chair |
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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 |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |