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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 1 year of study entry from TRUS - Clinical stages T1c to T2b - PSA <20 - Gleason score ≤6 if PSA <20 or Gleason score 3 + 4 = 7 or 4 + 3 = 7 if PSA <20 - Must have complete history and physical examination within 45 days of study entry and digital rectal examination of prostate within 180 days of study entry - Participants who are currently receiving Dutasteride (or have received it within the last 90 days) or Finasteride (or have received it within the last 30 days) must have a PSA of ≤ 10 Exclusion Criteria: - Prior surgery (not including TURP), 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 confirmed by a CT scan within 365 days of study entry - Hip prosthesis, inflammatory bowel disease or connective tissue disorder such as active scleroderma or lupus - History of other malignancies within the past 5 years - Individuals who have AIDS (CD4 < 200 or an AIDS-defining illness) or are HIV positive and not on HAART therapy are ineligible. - Major medical or psychiatric illness
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