Intensity-Modulated External Beam Radiation Therapy in Treating Patients With Prostate Cancer
This trial is active, not recruiting.
|Conditions||adenocarcinoma of the prostate, stage i prostate cancer, stage ii prostate cancer, stage iii prostate cancer, stage iv prostate cancer|
|Treatment||intensity modulated external beam radiation therapy|
|Sponsor||Virginia Commonwealth University|
|Start date||May 2010|
|End date||June 2015|
|Trial size||55 participants|
|Trial identifier||NCT01117935, MCC-12870, NCI-2010-00877|
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.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Endpoint classification||safety study|
|Intervention model||single group assignment|
Toxicity as measured by Common Terminology Criteria for Adverse Events (CTCAE) v3 criteria
time frame: At 2 years
Biochemical failure as defined by the Phoenix definition
time frame: 2 years
Male participants at least 18 years old.
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
|Official title||Study of Hypofractionated Intensity Modulated External Beam Therapy for the Treatment of Patients With Adenocarcinoma of the Prostate|
|Principal investigator||Michael G. Chang, MD|
|Description||PRIMARY OBJECTIVES: I. To demonstrate that patients can safely receive IMRT teletherapy using the proposed IMRT fractionation schedule without experiencing a treatment limiting toxicity. SECONDARY OBJECTIVES: I. To assess treatment efficacy through the surrogate measures of PSA nadir and biochemical failure-free survival. OUTLINE: Patients undergo hypofractionated intensity modulated radiotherapy once daily, 5 days a week, for 6 weeks in the absence of disease progression or unacceptable toxicity. Patients with intermediate- and high-risk disease may also receive concurrent and adjuvant or long-term androgen deprivation therapy for up to 36 months. After completion of study treatment, patients are followed at 4-6 weeks, every 4 months for 3 years, every 6 months for 2 years, and then annually until year 5.|
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