Enrollment complete
Androgen Deprivation Therapy and High Dose Radiotherapy With or Without Whole-Pelvic Radiotherapy in Unfavorable Intermediate or Favorable High Risk Prostate Cancer: A Phase III Randomized Trial
NCT No.: NCT01368588
Study Type: INTERVENTIONAL
Phase:
Phase III
Region: California - Northern
Acronym:
Official Title
Androgen Deprivation Therapy and High Dose Radiotherapy With or Without Whole-Pelvic Radiotherapy in Unfavorable Intermediate or Favorable High Risk Prostate Cancer: A Phase III Randomized Trial
Purpose
This randomized phase III trial studies androgen-deprivation therapy and radiation therapy in treating patients with prostate cancer.
Detailed Description
Age Limit
18 years & older
Eligibility Criteria
Inclusion Criteria
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Baseline serum PSA value performed with an FDA-approved assay (e.g., Abbott, Hybritech) within 12 weeks (90 days) prior to registration
Zubrod performance status 0-1
Absolute neutrophil count (ANC) >= 1,500/mm³
Platelet count >= 100,000/mm³
Hemoglobin (Hgb) >= 8.0 g/dL (transfusion or other intervention to achieve Hgb >= 8.0 g/dL is acceptable)
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Exclusion Criteria
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Evidence of bone metastases (M0) on bone scan within 120 days prior to registration (equivocal bone scan findings are allowed if plain films (or CT or MRI) are negative for metastasis)
Prior invasive (except non-melanoma skin cancer) malignancy unless disease-free for a minimum of 3 years (1,095 days) and not in the pelvis
Prior hematological (e.g., leukemia, lymphoma, or myeloma) malignancy
Prior allergic reaction to the hormones involved in this protocol
Prior radical surgery (prostatectomy) or cryosurgery for prostate cancer
Prior pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy
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Keywords and/or Specific Medical Conditions
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adenocarcinoma of the prostate
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Hormones, Hormone Substitutes, and Hormone Antagonists
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Physiological Effects of Drugs
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stage IIA prostate cancer
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stage IIB prostate cancer
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stage III prostate cancer
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Sponsors
- National Cancer Institute (NCI)
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- Radiation Therapy Oncology Group
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