This phase II trial studies the side effects and how well hypofractionated proton beam
radiation therapy works in treating patients with prostate cancer that has not spread to
nearby lymph nodes or to other parts of the body. Specialized radiation therapy, such as
proton beam radiation therapy, that delivers a high dose of radiation directly to the tumor
may kill more tumor cells and cause less damage to normal tissue.
- Brief Title: Hypofractionated Proton Beam Therapy for Localized Prostate Cancer
- Official Title: Phase II Trial of Hypofractionated Proton Beam Therapy in Men With Localized Prostate Adenocarcinoma
Clinical Trial IDs
- ORG STUDY ID:
- SECONDARY ID:
- NCT ID:
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.
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
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
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
Up to 150 participants will be enrolled in this study. All will take part at MD Anderson.
|Proton Beam Therapy||Experimental||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.|
1. Histologically confirmed diagnosis of adenocarcinoma of the prostate within one year
of study entry. Evaluation can happen outside of MD Anderson as long as histological
confirmation takes place at MD Anderson.
2. History/physical examination with digital rectal examination of the prostate within
90 days prior to registration
3. Histological evaluation of prostate biopsy with assignment of a Gleason score to the
biopsy material demonstrating Gleason score 2-7 within 365 days of registration.
4. Clinical stage T1-2b (AJCC 7th edition) and PSA <20 ng/mL within 90 days prior to
registration. PSA should not be obtained within 10 days after prostate biopsy.
5. Zubrod Performance Status 0-1 within 90 days prior to registration
6. Age greater than or equal to 18 years
7. Patient must be able to provide study-specific informed consent prior to study entry.
8. Willingness and ability to complete the EPIC questionnaire
1. Prior or concurrent invasive malignancy (except non-melanomatous skin cancer or
lymphomatous/hematogenous malignancy) unless continually disease free for a minimum
of 5 years
2. Evidence of distant metastases
3. Regional lymph node involvement
4. Previous prostatectomy, cryosurgery, or HIFU for prostate cancer
5. Previous pelvic radiation or prostate brachytherapy
6. Active and severe medical co-morbidity defined as follows: Unstable angina and/or
congestive heart failure requiring hospitalization within the last 6 months,
transmural myocardial infarction within the last 6 months, acute bacterial or fungal
infection requiring intravenous antibiotics at the time of registration, chronic
obstructive pulmonary disease exacerbation or other respiratory illness requiring
hospitalization or precluding study therapy at the time of registration, hepatic
insufficiency resulting in clinical jaundice, active inflammatory bowel disease
(Crohn's disease or ulcerative colitis), diagnosed connective tissue disorder, or
congenital coagulation defects (Patients on medical therapy with coumadin or other
blood thinning agents are eligible for participation.)
|Maximum Eligible Age:||N/A|
|Minimum Eligible Age:||18 Years|
Primary Outcome Measures
|Measure:||Incidence of Grade 2 Gastrointestinal Toxicity|
|Time Frame:||2 years|
|Description:||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.|
|Lead Sponsor:||M.D. Anderson Cancer Center|
- Prostate Cancer
- Localized prostate cancer
- Adenocarcinoma of the prostate
- Proton therapy
- Radiation therapy
October 31, 2016