Hypofractionated Proton Beam Therapy for Localized Prostate Cancer
The goal of this clinical research study is to learn if delivering proton therapy in higher doses per treatment may help control prostate cancer just as well as the standard of care treatment. The safety of this treatment will also be studied.
Radiation dose is measured in units called Gray (Gy). The standard of care treatment schedule for proton therapy is 1.8-2 Gy, given 1 time per day, 5 days per week over a period of 8-9 weeks.
Radiation: Proton Beam Therapy
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Hypofractionated Proton Beam Therapy in Men With Localized Prostate Adenocarcinoma|
- Incidence of Grade 2 Gastrointestinal Toxicity [ Time Frame: 2 years ] [ Designated as safety issue: No ]Primary endpoint is the incidence of late grade 2 or greater gastrointestinal toxicity (GI). Methods used described by Gooley et al. (1999) to estimate the cumulative incidence of late grade 2 or greater GI toxicity, considering death from any cause as a competing event, and cumulative incidence estimated at 2 years with a 95% confidence interval.
|Study Start Date:||October 2013|
|Estimated Primary Completion Date:||October 2019 (Final data collection date for primary outcome measure)|
Experimental: Proton Beam Therapy
The total dose will be 55.5 Gy (RBE) delivered in 15 fractions of 3.7 Gy (RBE) to the prostate. Each fraction will be scheduled once daily allowing at least one day between treated fractions. Symptom questionnaire completed at baseline, during the last weeks of proton therapy, 6 months, 36 months, 48 months, and 60 months after therapy.
Radiation: Proton Beam Therapy
55.5 Gy (RBE) delivered in 15 fractions of 3.7 Gy (RBE) to the prostate. Each fraction will be scheduled once daily allowing at least one day between treated fractions.
Other Name: XRTBehavioral: Questionnaire
Symptom questionnaire completed at baseline, during the last weeks of proton therapy, 6 months, 36 months, 48 months, and 60 months after therapy.
Other Name: Survey
Proton Therapy If you are eligible and agree to take part in this study, proton beam treatments will be delivered 2-3 days per week until you have received a total of 15 treatments.
You will receive proton beam therapy to the prostate. Your doctor will place 2-3 small tissue markers (about the size of grain of rice) into your prostate to help guide the proton therapy. Anesthesia is not needed for this procedure. For each treatment, you will lie on a treatment table for about 20-30 minutes.
During proton therapy you will talk with your doctor about how you are feeling 1 time every week.
During your last week of proton therapy you will complete the questionnaire.
For the first 24 months after proton therapy every 6-12 months, blood (about 2 tablespoons) will be drawn to check your PSA levels and you will complete the questionnaire. How often these visits occur will be up to the study doctor.
At 36, 48, and 60 months after proton therapy, blood (about 2 tablespoons) will be drawn to check your PSA levels and you will be asked to complete the questionnaire.
After proton beam therapy ends, if the study doctor thinks it is needed, you will have a digital rectal exam, an MRI, a bone scan, and/or a standard prostate biopsy to check the status of the disease.
Length of Study:
You will no longer be able to take part in this study if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions.
Your participation in this study will end 60 months after you complete proton therapy. Your doctor will continue to provide all necessary medical care after your participation has ended.
This is an investigational study. Proton beam therapy is delivered using an FDA approved and commercially available method. The alternative schedules of proton beam therapy are investigational.
Up to 150 participants will be enrolled in this study. All will take part at MD Anderson.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01950351
|Contact: Thomas Pugh, MD||713-563-8961|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Thomas Pugh, MD||M.D. Anderson Cancer Center|