Hypofractionated Boost vs Conventionally Fractionated Boost for Localized High Risk Prostate Cancer

Study Overview
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Brief Summary
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Randomized trial comparing 2 external beam radiotherapy fractionation schemes in patients with localized high risk prostate cancer. Primary endpoint is acute toxicity.

Detailed Description
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Patients enrolled onto this study will be randomized to one of the following treatment arms: 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. 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). In addition, all patients receive 1.5- 3 years of androgen deprivation therapy.

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: Conventionally Fractionated versus Hypofractionated Boost


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. 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
Interventional Model Description: Randomized Trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Fractionation<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. | Radiation: Conventionally Fractionated versus Hypofractionated Boost<br> <br> |
| Experimental: Hypofractionation<br>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). | Radiation: Conventionally Fractionated versus Hypofractionated Boost<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Toxicity | Proportion of patients experiencing grade >=2 acute toxicity | within 3 months after starting radiotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late Toxicity | Proportion of patients experiencing grade >= 2 late toxicity | beyond 3 months of starting radiotherapy | 
| Biochemical Control (Phoenix Definition) | Actuarial measure of patients failing biochemically (defined as PSA nadir + 2 ng/mL) | at 5 years | 
| Overall Survival | Actuarial measure of patients being alive | at 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High Risk Prostate Cancer, Radiotherapy