Hypofractionated Intensity Modulated Radiation Therapy Plus Hormonal Therapy in Patients With High Risk Prostate Cancer

Study Overview
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Brief Summary
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Considering the promising results with hypofractionated in low and intermediate risk prostate cancer, our proposal is to translate this experience to patients with high risk prostate cancer. Patients with high risk disease would receive hypofractionated RT to the prostate and to the external and internal iliac lymph nodes using IMRT plus long-term hormonal therapy. The objective of the study is to show that long term grade>2 late toxicity is acceptable and similar to published data using hypofractionated technique in the prostate only.

Official Title
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Hypofractionated Intensity Modulated Radiation Therapy Plus Hormonal Therapy in Patients With High Risk Prostate Cancer

Conditions
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High Risk Prostate Cancer

Intervention / Treatment
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* Radiation: IMRT Technique


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: pathologically proven diagnosis of adenocarcinoma of the prostate meeting one of the following conditions: Clinical Stage >T3 or Gleason Score 8 or higher, or PSA level >20ng/ml Study entry PSA must be obtained within 6 weeks prior to protocol entry ECOG <2 Age >18 History and physical examination within 3 months Bone scan and CT scan of the abdomen and pelvis within 3 months with no evidence of bone metastases and no pelvic lymph nodes larger than 1.0cm, unless biopsy negative. CBC with differential within 6 weeks prior to protocol entry Absolute neutrophil count >2000cells/mm3 Hemoglobin >8.0 g/dl (the use of transfusion to increase the Hg is acceptable) Testosterone level within 6 weeks of protocol entry Liver function tests Signed informed consent Prior use of hormonal therapy for prostate cancer is acceptable if less than 2 months. Exclusion Criteria: Prior use of hormonal therapy for prostate cancer for more than 2 months. Previous use of finasteride or dutasteride is allowed. Prior invasive malignancy (except non-melanoma skin) unless disease-free for more than 5 years. Prior radiotherapy to the pelvis Life expectancy of less than 2 years.

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IMRT Hypofractionated<br>Neo-adjuvant hormone therapy for three months followed by IMRT combined with a 24-month hormonal therapy. | Radiation: IMRT Technique<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity | Acute and late toxicity following treatment with IMRT to the prostate and pelvic lymphatic chains will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (http://ctep.cancer.gov) for grading of all adverse events will be used in this study. | First 3 months (acute toxicity) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from biochemical failure, patterns of failure. | To measure freedom from biochemical failure (PSA measurement) at 5 years. | At 5 years |