High-Dose Lymph Node Intensity Modulated Radiation Therapy and Hypofractionated Prostate (SIB)

Study Overview
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Brief Summary
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The purpose of this study is to find out the effects (good and bad) of using newer technologies that allow very precise delivery of radiation. These newer technologies are Intensity Modulated Radiation Therapy (IMRT) and Image Guided Radiation Therapy (IGRT).

Detailed Description
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In this study the treating physicians will deliver a high dose of radiation to pelvic lymph nodes of 56 Gy (Gy/Gray = measure of amount of radiation) and at the same time give a boost (additional) radiation to the prostate itself (to 70 Gy). The study will evaluate the response of the cancer and side effects of radiation to pelvic lymph nodes and to the prostate. It is hoped that these newer technologies will: allow a higher daily dose of radiation to the tumor and pelvic nodes avoid nearby normal tissue and organs like the rectum and bladder prevent the cancer from spreading or coming back

Official Title
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A Phase II Trial of High-Dose Pelvic Lymph Node IMRT( Intensity Modulated Radiation Therapy) and Hypofractionated Prostate IMRT for High Risk Prostate Cancer Patients

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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Inclusion Criteria: Histologically confirmed, adenocarcinoma of the prostate T1-2N0M0 with risk of pelvic lymph nodes involvement >25% by Roach formula [(2/3xPSA) + (Gleason Score - 6)x10], or any T3-4N0M0 Karnofsky Performance Scale > 70. Prostate tumor biopsy grading by Gleason score classification is mandatory prior to registration. No prior pelvic or prostate radiation or chemotherapy for any reason; induction hormonal therapy prior to registration is acceptable. Patients must sign a study-specific consent form prior to registration. No evidence of distant metastases (Bone scanning) Exclusion Criteria: Clinical or pathological evidence of distant metastases (M1). Radical surgery for carcinoma of the prostate History of prior chemotherapy History of prior pelvic radiation therapy Children (age < 18).

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 & IGRT Radiation Therapy<br>In this study we will deliver a high dose of radiation to the pelvic lymph nodes of 56 Gy (Gy/Gray = measure of amount of radiation) and at the same time give a boost (additional) radiation to the prostate itself (to 70 Gy). | Radiation: Radiation Therapy<br>* A high dose of radiation to the pelvic lymph nodes of 56 Gy (Gy/Gray = measure of amount of radiation) and at the same time give a boost (additional) radiation to the prostate itself (to 70 Gy).<br>* Other names: Intensity Modulated Radiation Therapy (IMRT) and Image Guided Radiation Therapy (IGRT).;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline PSA level | PSA level in blood is measured in units of nanograms per milliliter. | 4 months | 
| Change from baseline PSA level | PSA level in blood is measured in units of nanograms per milliliter. | 7 months | 
| Change from baseline PSA level | PSA level in blood is measured in units of nanograms per milliliter. | 10 months | 
| Change from baseline PSA level | PSA level in blood is measured in units of nanograms per milliliter. | 13 months | 
| Change from baseline PSA level | PSA level in blood is measured in units of nanograms per milliliter. | 16 months | 
| Change from baseline PSA level | PSA level in blood is measured in units of nanograms per milliliter. | 19 months | 
| Change from baseline PSA level | PSA level in blood is measured in units of nanograms per milliliter. | 22 months | 
| Change from baseline PSA level | PSA level in blood is measured in units of nanograms per milliliter. | 25 months | 
| Change from baseline PSA level | PSA level in blood is measured in units of nanograms per milliliter. | 31 months | 
| Change from baseline PSA level | PSA level in blood is measured in units of nanograms per milliliter. | 37 months | 
| Change from baseline PSA level | PSA level in blood is measured in units of nanograms per milliliter. | 43 months | 
| Change from baseline PSA level | PSA level in blood is measured in units of nanograms per milliliter. | 49 months | 
| Change from baseline PSA level | PSA level in blood is measured in units of nanograms per milliliter. | 55 months |