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| Overall Recruitment Status: Enrollment on hold |
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| Official Title |
| 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
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| Region |
Sponsors |
| California - Northern |
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| Acronym |
NCT No. |
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NCT00936390 |
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| Study Type |
Phase |
| Clinical Trial |
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| Purpose |
| This randomized phase III trial is studying radiation therapy to see how well it works compared with radiation therapy given together with androgen-deprivation therapy in treating patients with prostate cancer. |
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| Detailed Description |
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- Pathologically (histologically) proven diagnosis of prostatic adenocarcinoma, at intermediate risk for recurrence, within 180 days prior to registration as determined by having one or more of the following intermediate-risk features: Gleason score 7
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- prostate-specific antigen (PSA) >10 but =20
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Clinically negative lymph nodes as established by imaging (pelvic +/- abdominal CT or MRI), nodal sampling, or dissection within 60 days prior to registration
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No evidence of bone metastases (M0) on bone scan within 60 days prior to registration.
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History/physical examination (to include, at a minimum, digital rectal examination of the prostate and examination of the skeletal system and abdomen, and formal comorbidity assessment via the ACE-27 instrument) within 60 days prior to registration.
Zubrod Performance Status 0-1
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- Patients with Gleason Score = 8
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- OR Clinical Stage = T3 are ineligible for this trial.
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Patients with all three intermediate risk factors who also have = 50% of the number of their biopsy cores positive for cancer are ineligible for this trial.
Prior invasive malignancy (except non-melanomatous skin cancer) or hematological (e.g., leukemia, lymphoma, myeloma) malignancy unless disease free for a minimum of 5 years (prior diagnoses of carcinoma in situ are permitted)
Prior radical surgery (prostatectomy), high-intensity focused ultrasound (HIFU) or cryosurgery for prostate cancer
Prior hormonal therapy, such as LHRH agonists (e.g., goserelin, leuprolide), antiandrogens (e.g., flutamide, bicalutamide), estrogens (e.g., DES), or bilateral orchiectomy
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adenocarcinoma of the prostate,
stage IIB prostate cancer, stage IIA prostate cancer,
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