Clinical Trial Details

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Study ID MCC-12870
Michael G. Chang, MD,   Virginia Commonwealth University
Title Intensity-Modulated External Beam Radiation Therapy in Treating Patients With Prostate Cancer
Conditions Adenocarcinoma of the Prostate
Stage I Prostate Cancer
Stage II Prostate Cancer
Stage III Prostate Cancer
Stage IV Prostate Cancer
Interventions Radiation: intensity modulated external beam radiation therapy
Phase Phase 1
Purpose RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Specialized radiation therapy, such as intensity-modulated radiation therapy, that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. PURPOSE: This clinical trial studies intensity-modulated external beam radiation therapy in treating patients with prostate cancer.
Eligibility Ages Eligible: 18 Years
Genders Eligible:  Male
Accepts Healthy Volunteers:  No
Inclusion Criteria:
  • Patients with biopsy-proven adenocarcinoma of the prostate are eligible for protocol enrollment when the following criteria are met; patients must have low, intermediate or high-risk adenocarcinoma of the prostate, as defined by the National Comprehensive Cancer Network (NCCN) criteria
  • A diagnostic CT scan of the abdomen and pelvis will be obtained to rule out regional disease (maximum of 60 days prior to registration) for high-risk patients only
  • A bone scan showing no evidence of metastatic disease is also required for patients whose prostate-specific antigen (PSA) is greater than 20 ng/ml, Gleason's sum is greater than 7, or T-stage is greater than T2b
  • Alkaline phosphatase within 1.5 x upper limit of normal (ULN) is required for all patients beginning hormone therapy
  • AST within 1.5 x ULN is required for all patients beginning hormone therapy
  • Bilirubin within 1.5 x ULN is required for all patients beginning hormone therapy
  • Karnofsky Performance score >= 80
  • Prior to registration, patients having received no more than three months treatment with anti-androgen, luteinizing hormone-releasing hormone (LHRH) agonist, or a combination of the two remain eligible for protocol treatment; the qualifying PSA for these patients will be the value recorded prior to the initiation of the hormone therapy Exclusion Criteria:
  • Patients with history of inflammatory bowel disease, or who require steroid or cytotoxic therapy for collagen vascular disease
  • Patients with a history of cancer other than skin cancer within five years of the initiation of protocol treatment
  • Patients with a history of pelvic irradiation for any reason
  • Study Location N/A
    Contact N/A

    Information obtained from, on 7/31/2015. For additional information about this and other clinical trials, visit
    Please refer to this study by its identifier: NCT01117935

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