Intensity-Modulated Radiation Therapy in Treating Patients With Stage I, Stage II, Stage III, or Stage IV Prostate Cancer

Study Overview
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Brief Summary
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RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Using scintigraphy to plan 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/II trial is studying the side effects and best way to give intensity-modulated radiation therapy and to see how well it works in treating patients with stage I, stage II, stage III, or stage IV prostate cancer.

Detailed Description
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OBJECTIVES: To assess the feasibility of radioimmunoguided intensity-modulated radiotherapy (IMRT) for stage I-IV prostate cancer. To determine the toxicity and tolerance of this regimen in these patients. To determine the tumor response based on physical examination and serial measurements of the serum prostate-specific antigen (PSA) levels in these patients. To determine the outcome of patients treated on this study with radioimmunoguided IMRT compared to 2 control groups of patients treated at Mayo Scottsdale Clinic (MSC). OUTLINE: Patients undergo radioimmunoguided intensity-modulated radiotherapy once daily, 5 days a week for 8½ weeks. Beginning the last week of radiotherapy, some patients receive leuprolide acetate intramuscularly every 3-4 months or goserelin subcutaneously every 3 months for 6 months, 12 months, or until disease progression. After completion of study treatment, patients are followed every 3-4 months for 1 year, every 6 months for 4 years and annually thereafter

Official Title
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Phase I/II Study of Radioimmunoguided Intensity Modulated Radiotherapy (IMRT) for Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: goserelin acetate
* Drug: leuprolide acetate
* Radiation: image-guided radiation therapy
* Radiation: intensity-modulated radiation therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Pathologically confirmed prostate cancer Stage I-IV disease (T1-4, N0-1, M0) No evidence of distant metastases (M0) on physical examination or bone scan PATIENT CHARACTERISTICS: ECOG performance status 0-2 Hemoglobin ≥ 10.0 g/dL WBC ≥ 3,000/mcL Platelet count ≥ 90,000/mm AST < 2 times the upper limit of normal No allergy to leuprolide acetate or goserelin PRIOR CONCURRENT THERAPY: Not specified

Ages Eligible for Study
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Minimum Age: 19 Years

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
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: goserelin acetate|nan|
|Drug: leuprolide acetate|nan|
|Radiation: image-guided 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 |
| --- | --- | --- |
| Toxicity |  |  | 
| Survival rates |  |  | 
| Freedom from biochemical relapse rates |  |  | 
| Local control rates |  |  | 
| Distant failure rates |  |  | 
| Biochemical freedom from failure rates |  |  | 
| Comparison of outcomes to patients treated with conventional radiotherapy and intensity-modulated radiotherapy without radioimmunoguidance |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Obstructive urinary symptoms |  |  | 
| Sexual health as assessed by inventory questionnaire |  |  | 

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