Proton Therapy vs. IMRT for Low or Intermediate Risk Prostate Cancer

Status: Recruiting
Phase: Phase 3
Diagnosis: Prostate Cancer
NCT ID: NCT01617161 (View complete trial on
DFCI Protocol ID: 11-497


We are studying whether men being treated for prostate cancer have the same amount of side effects from either one of two different external radiation treatments: IMRT or PBT. With IMRT, a number of x-ray beams are used to shape the radiation to the prostate. PBT is another type of external radiation treatment for prostate cancer that is used in a few centers in the United States. Protons are tiny particles with positive charge that can be controlled to travel a certain distance and stop. PBT is precise like IMRT, but it uses proton beams instead of x-ray beams. IMRT and PBT aim to deliver most of the radiation to the prostate cancer while sparing surrounding tissues. Both IMRT and PBT have been used in the treatment of prostate cancer and are thought to be equally effective at curing prostate cancer. However, both treatments have also been shown to cause the potential side effects of radiation, including bowel, urinary and erectile problems. It is possible that side effect rates with PBT will be lower, the same, or even higher than with IMRT, but this has not been studied well to date. Though both of these radiation therapies have been used in the past to treat prostate cancer, there has never been a study that compares the effects of these two therapies to see which one has less side effects. In this research study, we are comparing IMRT to PBT to determine which therapy best minimizes the side effects of treatment.


Conducting Institutions:
Massachusetts General Hospital

Overall PI:
Jason Efstathiou, MD, Massachusetts General Hospital

Site-responsible Investigators:

Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

Inclusion Criteria: - Diagnosed with histologically confirmed adenocarcinoma of the prostate based on core-biopsy within 180 days of study entry from TRUS - Clinical stages T1c to T2b - Must have complete history and physical examination including digital rectal examination of prostate within 30 days of study entry - May have received finasteride as long as it was discontinued at least 30 days prior to study entry - May have received dutasteride as long as it was discontinued at least 90 days prior to study entry Exclusion Criteria: - Prior surgery, cryosurgery, radiofrequency ablation, chemotherapy or radiation for PCa - Prior or planned androgen deprivation or bilateral orchiectomy - Distant metastases, or clinically or pathologically involved lymph nodes - Hip prosthesis, inflammatory bowel disease or connective tissue disorder such as active scleroderma or lupus - History of other malignancies within the past 5 years - History of HIV positivity - Major medical or psychiatric illness
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