Intensity-Modulated Radiation Therapy in Treating Patients With Prostate Cancer

Study Overview
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Brief Summary
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RATIONALE: Specialized 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 phase I trial is studying the best dose of intensity-modulated radiation therapy in treating patients with prostate cancer.

Detailed Description
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OBJECTIVES: To test the feasibility of delivering hypofractionated intensity-modulated radiotherapy to the prostate and pelvic nodes of patients with prostate cancer. To determine the optimal dose level of this treatment regimen to be used in future studies. OUTLINE: Patients are stratified according to small bowel total volume (low small bowel volume < 450 cc vs high small bowel volume ≥ 450 cc). Patients undergo hypofractionated intensity-modulated radiotherapy to the prostate and pelvis for 4 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months for 5 years and then annually thereafter.

Official Title
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A Phase I Dose Escalation Study of the Use of Intensity Modulated Radiotherapy (IMRT) to Treat Prostate and Pelvic Nodes in Patients With Prostate Cancer - Pelvic IMRT for Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Radiation: hypofractionated radiation therapy
* Radiation: intensity-modulated radiation therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of prostate cancer meeting 1 of the following criteria: Stage T3b/T4 disease or radiological or pathological pelvic nodal metastases Localized disease (stage pT2-T4) with > 30% estimated risk of pelvic nodal metastases High-risk (Gleason score ≥ 8 or ≥ 2 risk factors) or very high-risk disease according to the National Collaborative Cancer Network (NCCN) Has undergone prostatectomy AND has stage T2-T3a, N0 disease with extensive high-risk disease (Gleason score ≥ 8) or seminal vesicle or lymph node involvement Candidate for radical radiotherapy PATIENT CHARACTERISTICS: No inflammatory bowel disease or other small bowel disease PRIOR CONCURRENT THERAPY: No prior pelvic radiotherapy or surgery (excluding prostatectomy)
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: hypofractionated radiation therapy|nan|
|Radiation: intensity-modulated radiation therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late RTOG radiotherapy toxicity as assessed at 6, 12, 18, and 24 months and then annually thereafter |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  |  | 
| Local control |  |  | 
| PSA control |  |  | 
| Acute side effects as assessed weekly by the RTOG scoring system |  |  | 
| Quality of life |  |  | 
| Patterns of recurrence |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer