Trial of Hypofractionated IMRT Boost Versus Conventional IMRT Boost for Localized High Risk Prostate Cancer

Study Overview
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Brief Summary
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Hypofractionation: 48 Gy in 25 fractions to pelvic lymph nodes while the prostate receives 68 Gy in 25 fractions concomitantly. Standard Fractionation: pelvic lymph nodes and prostate will initially be treated to 46 Gy in 23 fractions, followed by a subsequent boost to the prostate to a total dose of 78 Gy over 39 fractions.

Detailed Description
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Half the participants will receive using a one phase IMRT plan, the pelvic lymph nodes will be treated to a dose of 48 Gy in 25 fractions, while the prostate will be treated to a dose of 68 Gy in 25 fractions concomitantly (simulataneous integrated boost). The other half of the participants will receive Standard fractionation using 2 sequential IMRT plans, the pelvic lymph nodes and prostate will initially be treated to 46 Gy in 23 fractions, followed by a subsequent boost to the prostate to a total dose of 78 Gy.

Official Title
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Randomized Trial of Concomitant Hypofractionated IMRT Boost Versus Conventional Fractionated IMRT Boost for Localized High Risk Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Radiation: Hypofractionated IMRT Radiation treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent obtained. Histologically confirmed diagnosis of adenocarcinoma of the prostate. Clinical stage T1-2 N0 M0, Gleason Score ≤ 7, PSA 20 - 100 T1-2 N0 M0, Gleason Score 8 - 10, PSA ≤ 100 T3 N0 M0, any Gleason Score, PSA ≤ 100 Exclusion Criteria: Patients with unilateral or bilateral hip replacement. Patients with active collagen vascular disease. Patients with active inflammatory bowel disease. Patients with previous radiotherapy to the pelvis. Patients with ataxia telangiectasia. Patients with nodal or distant metastases

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 |
| --- | --- |
| Experimental: Hypofractionation<br>Hypofractionation: Using a one phase IMRT plan, the pelvic lymph nodes will be treated to a dose of 48 Gy in 25 fractions, while the prostate will be treated to a dose of 68 Gy in 25 fractions concomitantly (simulataneous integrated boost) + 18-36 months of Eligard Hormone injection. | Radiation: Hypofractionated IMRT Radiation treatment<br> <br> * Other names: Eligard 22.5 mg (28.2 mg leuprolide acetate per syringe) [3-Month] for 18-36 months;|
| Active Comparator: Standard Fractination<br>Using 2 sequential IMRT plans, the pelvic lymph nodes and prostate will initially be treated to 46 Gy in 23 fractions, followed by a subsequent boost to the prostate to a total dose of 78 Gy + 18-36 months of Eligard Hormone injection. | Radiation: Hypofractionated IMRT Radiation treatment<br> <br> * Other names: Eligard 22.5 mg (28.2 mg leuprolide acetate per syringe) [3-Month] for 18-36 months;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival | The primary outcome for this study is PSA biochemical disease free survival at 5 years. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late GI and GU toxicities | Number of participants with treatment-related adverse events as assessed by CTCAE v3.0, change from 6 months post treatment to end of 5 year follow-up. | 6 month post completion of treatment to end of 5 year follow up | 
| Quality of life outcome: Expanded Prostate Index Composite (EPIC) | Measuring quality of life using the Expanded Prostate Cancer Index Composite (EPIC) questionnaire. The EPIC questionnaire consists of 50 questions. Each question is scored from 1-5, 5 being the better outcome and 1 being the worst outcome in most of the questions | Baseline (start of treatment) to end of 5 year follow-up | 
| Overall survival | Overall survival comparing two treatment arms | Baseline to end of 5 year follow-up | 
| Cancer specific survival | Cancer specific survival comparing two treatment arms | Baseline to end of 5 year follow-up |