Comparison of Two Radiation Therapy Regimens in Treating Patients With Stage II or Stage III Prostate Cancer

Study Overview
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Brief Summary
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RATIONALE: Radiation therapy uses high-energy x-rays and other sources of radiation to kill tumor cells. It is not yet known which radiation therapy regimen is more effective in treating prostate cancer. PURPOSE: This randomized phase III trial is comparing two different regimens of radiation therapy to see how well they work in treating patients with stage II or stage III prostate cancer.

Detailed Description
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OBJECTIVES: Compare the efficacy of conventional intensity-modulated radiotherapy (IMRT) vs hypofractionated IMRT, in terms of freedom from biochemical failure in men with intermediate- to high-risk prostate cancer. Compare the local control, freedom from distant metastasis, and overall survival of patients treated with these regimens. Determine local failure, using biopsy of the prostate, when objective tests (prostate-specific antigen, ultrasound, and digital rectal exam) suggest relapse in these patients. Compare the extent of disease eradication using biopsy of the prostate at 2 years after therapy in these patients. Compare the quality of life of patients treated with these regimens. Determine the impact of these regimens on patient preferences and utilities. OUTLINE: This is a randomized study. Patients are stratified according to pretreatment prostate-specific antigen (no greater than 10 ng/mL vs greater than 10 to 20 ng/mL vs greater than 20 ng/mL), Gleason score (5-7 vs 8-10), and risk status (high risk vs intermediate risk). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients undergo conventional intensity-modulated radiotherapy (IMRT) 5 days a week for 7.5 weeks in the absence of disease progression or unacceptable toxicity. Arm II: Patients undergo hypofractionated IMRT 5 days a week for 5 weeks in the absence of disease progression or unacceptable toxicity. Patients with high-risk disease also undergo androgen deprivation therapy for 2 years. Quality of life is assessed at baseline, every 6 months for 1 year, and then annually for 4 years. Patients are followed at 3 months, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 300 patients (150 per treatment arm) will be accrued for this study within 3 years.

Official Title
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A Phase III Intensity Modulated Radiotherapy Dose Escalation Trial for Prostate Cancer Using Hypofractionation

Conditions
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Prostate Cancer

Intervention / Treatment
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* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate Clinical stage T1b-T3c disease No clinical or radiographic evidence of metastasis Prostate-specific antigen (PSA) less than 80 ng/mL Gleason score at least 5 One of the following criteria must be met: PSA greater than 10 ng/mL Gleason score greater than 6 T2b or greater palpable disease Three or more biopsy cores involved with a Gleason score of at least 5 PATIENT CHARACTERISTICS: Age Not specified Performance status Zubrod 0-1 Life expectancy Not specified Hematopoietic Not specified Hepatic Not specified Renal Not specified Other No other medical condition that would preclude study participation No other active malignancy within the past 5 years except nonmetastatic skin cancer or early stage chronic lymphocytic leukemia (well-differentiated small cell lymphocytic leukemia) Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy No more than 4 months of prior androgen deprivation therapy Neoadjuvant and adjuvant androgen deprivation therapy is allowed for high-risk disease only Radiotherapy No prior pelvic radiotherapy Surgery No prior or planned radical prostate surgery

Ages Eligible for Study
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Minimum Age: 18 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CIMRT<br>76 Gy in 38 fractions | Radiation: radiation therapy<br> <br> |
| Experimental: HIMRT<br>70.2 Gy in 26 fractions | Radiation: radiation therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from biochemical and/or disease failure rates |  | weekly during treatment, at 3 months, 6 months or 2 years then yearly | 

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