Phase III Randomized Clinical Trial of Proton Therapy vs. IMRT for Low or Low-Intermediate Risk Prostate Cancer
Because no one knows which of the study options is best, you will be "randomized" into one
of the study groups: IMRT or PBT. Randomization means that you are put into a group by
chance, like flipping a coin. Neither you nor the research doctor will choose which group
you will be in. You will have an equal chance of being placed in either group. Randomization
makes the study better from a scientific point of view because it helps ensure that patients
receiving IMRT and proton therapy are similar. You will be receiving only one type of
radiation, either IMRT or PBT throughout your participation in the study.
Before you begin radiation therapy you will have a pelvic CT scan in order to design your
radiation treatment. Doctors will use information gathered from these scans to plan the best
way to deliver radiation to your tumor.
Both types of radiation therapy will be given once a day for 5 days (no weekends or
holidays) over the course of 8-9 weeks. Both IMRT and PBT will require that you lie on a
table for less than 15 minutes to obtain your treatment.
During each visit you will be asked questions about your general health and specific
questions about any problems that you might be having and any medications you might be
taking. You will also undergo a physical exam and complete some quality of life
questionnaires.
After your radiation therapy you will have follow up visits at 3,6,9,12,18,24,36,48 and 60
months.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Efficacy of PBT vs. IMRT
Compare the reduction in mean EPIC bowel scores for men with low or low-intermediate risk PCa treated with PBT versus IMRT at 24 months following radiation (where higher scores represent better outcomes)
2 years
No
Jason A Efstathiou, MD, DPhil
Principal Investigator
Massachusetts General Hospital
United States: Dana-Farber Cancer Institute IRB
11-497
NCT01617161
July 2012
Name | Location |
---|---|
Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
Hospital of the University of Pennsylvania | Philadelphia, Pennsylvania 19104 |