Intensity-Modulated External Beam Radiation Therapy in Treating Patients With Prostate Cancer
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
PRIMARY OBJECTIVES:
- To demonstrate that patients can safely receive IMRT teletherapy using the proposed IMRT fractionation schedule without experiencing a treatment limiting toxicity.
SECONDARY OBJECTIVES:
- 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm I 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. |
Radiation: intensity modulated external beam radiation therapy
Low risk - 69.6 Gy in 2.4 Gy fractions to prostate
Intermediate risk - delivered in 30 fractions with neoadjuvant and concurrent androgen deprivation therapy: 72 Gy in 2.4 Gy fractions to prostate + 60 Gy in 2 Gy fractions to seminal vesicles +/- 50.4 Gy in 1.68 Gy fractions to lymph nodes
High risk - 30 fractions with neoadjuvant, concurrent, and long term adjuvant androgen deprivation therapy: 72 Gy in 2.4 Gy fractions to prostate + 60 Gy in 2 Gy fractions to seminal vesicles +/- 50.4 Gy at 1.68 Gy fractions to lymph nodes
Other Names:
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Outcome Measures
Primary Outcome Measures
- Toxicity as measured by Common Terminology Criteria for Adverse Events (CTCAE) v3 criteria [At 2 years]
Secondary Outcome Measures
- Biochemical failure as defined by the Phoenix definition [2 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
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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
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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
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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
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Alkaline phosphatase within 1.5 x upper limit of normal (ULN) is required for all patients beginning hormone therapy
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AST within 1.5 x ULN is required for all patients beginning hormone therapy
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Bilirubin within 1.5 x ULN is required for all patients beginning hormone therapy
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Karnofsky Performance score >= 80
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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:
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Patients with history of inflammatory bowel disease, or who require steroid or cytotoxic therapy for collagen vascular disease
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Patients with a history of cancer other than skin cancer within five years of the initiation of protocol treatment
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Patients with a history of pelvic irradiation for any reason
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hunter Holmes McGuire Veterans Administration Medical Center | Richmond | Virginia | United States | 23249 |
| 2 | Virginia Commonwealth University/Massey Cancer Center | Richmond | Virginia | United States | 23298 |
Sponsors and Collaborators
- Virginia Commonwealth University
Investigators
- Principal Investigator: Michael G. Chang, MD, Massey Cancer Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- MCC-12870
- NCI-2010-00877