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Title:
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A Phase III Prospective Randomized Trial of Dose-Escalated Radiotherapy With or Without Short-Term Androgen Deprivation Therapy for Patients With Intermediate-Risk Prostate Cancer - IRB# 10-041B
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Treatments:
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Hormonal Therapy, Radiation Therapy
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Disease Site:
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Genitourinary
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Disease SubSite:
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Prostate
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Drug Provided:
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-- none --
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Comments:
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Eligibility:
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Histologically confirmed adenocarcinoma of the prostate diagnosed within the past 6 months and at intermediate-risk for recurrence by meeting =>1 of the following criteria: Gleason score >7, PSA >10, and =< 20 ng/mL, Baseline serum PSA value performed within 60 days with an FDA-approved assay (e.g., Abbott, Hybritech) . Baseline PSA must not be obtained during any of the following time frames:10-day period after prostate biopsy, after initiation of androgen-deprivation therapy, or within the past 30 days after discontinuation of finasteride (90 days for dutasteride). Clinical stage T2b or T2c disease. No patients with all 3 intermediate-risk factors who also have => 50% of the number of their biopsy cores positive for cancer . The percentage of biopsy cores involved will only be considered with respect to eligibility for those patients with all 3 of the above risk factors (i.e., patients with one or two of the above risk factors are eligible irrespective of the percentage of biopsy cores involved). Clinically negative lymph nodes as established by imaging (pelvic and/or abdominal CT scan or MRI), nodal sampling, or dissection within the past 60 days (required for patients with 2-3 risk factors). Abdominal imaging not required for a single intermediate-risk factor (these studies may be obtained at the discretion of the treating physician). Lymph nodes that are equivocal or questionable by imaging allowed without biopsy if nodes =<1.5 cm. Any node >1.5 cm on imaging requires a negative biopsy. No evidence of bone metastases on bone scan within the past 60 days. Bone scan not required for patients with a single intermediate-risk factor (scan may be obtained at the discretion of the treating physician). Equivocal bone scan findings allowed if plain film x-rays negative for metastasis.
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Participating Sites:
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Adventist Medical Center, Providence Portland Medical Center, Providence St. Vincent Medical Center, Northwest Cancer Specialists - Vancouver
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