Prostate Cancer Clinical Trial

Intensity-Modulated External Beam Radiation Therapy in Treating Patients With Prostate Cancer

Summary

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.

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Full 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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Eligibility Criteria

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 is for people with:

Prostate Cancer

Estimated Enrollment:

55

Study ID:

NCT01117935

Recruitment Status:

Completed

Sponsor:

Virginia Commonwealth University

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There are 2 Locations for this study

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Hunter Holmes McGuire Veterans Administration Medical Center
Richmond Virginia, 23249, United States
Virginia Commonwealth University/Massey Cancer Center
Richmond Virginia, 23298, United States

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Study is for people with:

Prostate Cancer

Estimated Enrollment:

55

Study ID:

NCT01117935

Recruitment Status:

Completed

Sponsor:


Virginia Commonwealth University

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