Proton Boost in Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
This study uses photon radiation with a proton boost to treat prostate cancer. The purpose of this study is to determine if proton therapy as a boost following photon intensity modulated radiation therapy (IMRT) produces decreased toxicity as compared to conventional photon IMRT alone in the treatment of prostate cancer. Our secondary objective is to determine the effectiveness of this treatment regimen. Effectiveness will be determined by length of time to progression or recurrence of disease and overall survival. Patients on this study will be treated with a course of photon radiation therapy followed by a boost course of proton radiation.

Official Title
-----------------
Assessing the Effectiveness of Photon Therapy With a Proton Therapy Boost in the Treatment of Prostate Cancer as Compared to Photon Therapy Alone

Conditions
-----------------
Cancer of the Prostate

Intervention / Treatment
-----------------
* Radiation: Proton Boost


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥18 years of age Diagnosis of low risk prostate cancer (T1c-T2a, Gleason 6, Prostate Specific Antigen (PSA) <10) -OR- Diagnosis of intermediate risk prostate cancer (T1c-T2c, Gleason 7 and/or PSA 10- 20) Life expectancy >10 yrs Physically and mentally capable of signing the consent form of their own volition Exclusion Criteria: < 18 years of age Diagnosis of high risk prostate cancer (T3 or higher, Gleason >7 and/or PSA >20) Current or historical use of androgen deprivation therapy Nodal positivity Previous cancer excluding non-melanoma skin cancer History of prostatectomy History of brachytherapy for prostate cancer Life expectancy <10 yrs Physically or mentally incapable of signing the consent form of their own volition

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Matched pair analysis. Each prospective patient will be matched with two historical patients based on the inclusion, exclusion and match criteria.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prospective Treatment Group<br>Proton Boost | Radiation: Proton Boost<br>* 13-15 treatments with proton therapy given as a boost to standard of care photon therapy<br>|
| No Intervention: Retrospective Comparison Group<br>Retrospective patients previously treated with standard of care photon therapy. There is no patient interaction with this group. Data collection from medical records only. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hematuria - Change from baseline | Common Terminology Criteria for Adverse Events - Hematuria Scale - 1(least severe) - 5 (most severe) | Post therapy - 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months, 6,7,8,9,10 years | 
| Urinary Incontinence - Change from baseline | Common Terminology Criteria for Adverse Events - Urinary Incontinence Scale - 1(least severe) - 3 (most severe) | Post therapy - 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months, 6,7,8,9,10 years | 
| Dysuria - Change from baseline | Presence or Absence | Post therapy - 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months, 6,7,8,9,10 years | 
| International Prostate Symptom Score - Change from baseline | Records patient reported urinary symptoms - Scale 1-35 - 1-7 Mild symptoms, 8-19 Moderate symptoms, 20-35 Severe symptoms | Post therapy - 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months, 6,7,8,9,10 years | 
| Rectal Bleeding - Change from baseline | Common Terminology Criteria for Adverse Events - Rectal Hemorrhage Scale - 1(least severe) - 5 (most severe) | Post therapy - 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months, 6,7,8,9,10 years | 
| Erectile Dysfunction - Change from baseline | Common Terminology Criteria for Adverse Events - Erectile Dysfunction Scale - 1(least severe) - 3 (most severe) | Post therapy - 1, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, 54, 60 months, 6,7,8,9,10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival | Measured by time to cancer recurrence | Monitored for 10 years after completion of radiation therapy | 
| Overall Survival | Measured by time to cancer-related death | Monitored for 10 years after completion of radiation therapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Radiation Therapy, Proton Therapy