Study of Hypofractionated Proton Beam Radiation Therapy for Prostate Cancer

Study Overview
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Brief Summary
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The purpose of this study is to determine hypofractionated conformal proton beam radiation therapy of prostate cancer can achieve similar treatment benefits as our current institutional standard with conventional fractionation.

Detailed Description
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Radiation therapy has a long and established role in the curative treatment of organ-confined prostate cancer. However, the optimal radiation dose and treatment schedule remain unknown. The use of hypofractionation has a long and generally successful history in conformal proton beam therapy. Several reports detailing the efficacy and safety of hypofractionated conformal radiation therapy (with x-rays) of prostate cancer can be found in the literature. Hypofractionated conformal proton beam radiation therapy has become our institutional routine for the treatment of numerous solid tumors. The purpose of this study is to determine if a shortened overall treatment schedule will result in equivalent tumor control rates and no increased side effects as compared to our current institutional standard treatment of an equivalent dose given over a longer period of time.

Official Title
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Phase I-II Trial of Hypofractionated Conformal Proton Beam Radiation Therapy for Favorable-risk Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Radiation: Proton Radiation
* Radiation: Proton


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed adenocarcinoma within 180 days of registration History & Physical Exam, including digital rectal exam (DRE), within 8 wks prior to registration Histologic evaluation of prostate biopsies at LLUMC, with Gleason score assignment Clinical stage, Tumor Stage (T1-T2C) Prostatic Specific Antigen (PSA) less than 10 ng.ml within 180 days prior to registration Exclusion Criteria: Prior or concurrent invasive malignancy Evidence of distant metastasis

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: Proton radiation therapy<br>Single arm | Radiation: Proton Radiation<br>* 3 Cobalt Gray Equivalent (CGE) /Day to isocenter, one treatment per day, 5 days per week for 20 treatments (=60 CGE to isocenter/20 fractions)<br>Radiation: Proton<br>* As above<br>* Other names: Proton Radiation treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Late Treatment-Related Toxicity Greater Than or Equal to Grade 3, CTCAE Version 4.0 | To determine if late CTCAE version 4.0 Grade 3 treatment-related morbidity, which is no worse than that engendered by our current institutional standard with conventional fractionation, can be maintained in a hypofractionated schedule. | Every 6 months after completing treatment through the duration of the trial with a minimum of 2 years follow-up and an average of 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Acute and Late Gastrointestinal or Genitourinary Grade 2 Morbidity, CTCAE Version 4.0 | To determine if late CTCAE version 4.0 Grade 2 treatment-related morbidity, which is no worse than that engendered by our current institutional standard with conventional fractionation, can be maintained in a hypofractionated schedule. | Every 6 months after completing treatment through the duration of the trial, with a minimum of 2 years follow-up and an average of 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypofractionation, proton beam radiation