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

Running, not enrolling · Not applicable

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT01617161

Run by

Massachusetts General Hospital

People needed

454

Starts

2012-07-25

Expected to finish

2030-12-01

Last updated by the study team

2026-04-24

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosed with histologically confirmed adenocarcinoma of the prostate based on core-biopsy within 1 year of study entry from TRUS
• Clinical stages T1c to T2c
• PSA <20, within 6 months 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
• Gleason score ≤6, 3 + 4 = 7, or 4 + 3 = 7
• ECOG Performance Status 0-1 as documented within 3 months prior to study entry
• 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

You may not qualify if…

• 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
• Individuals with a history of other malignancies are ineligible unless 1) they have been disease-free for at least 5 years OR 2) are deemed by the investigator to be at low risk for recurrence of that malignancy with no plans for adjuvant systemic chemotherapy and/or radiation therapy and have received overall principal investigator approval.
• 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
• Individuals with any of the following conditions are excluded from this study:
• 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
• History of Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects within the last 12 months

Where it is running

• University of Florida Health Proton Therapy Institute — Jacksonville, Florida, United States
• Northwestern Medicine Chicago Proton Center — Chicago, Illinois, United States
• University of Maryland Medical Center — College Park, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Mass General/North Shore Cancer Center — Danvers, Massachusetts, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Washington University — St Louis, Missouri, United States
• Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
• Princeton ProCure Proton Therapy Center — Somerset, New Jersey, United States
• University Hospital of Cleveland — Cleveland, Ohio, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Provision Proton Therapy Center — Knoxville, Tennessee, United States
• University of Washington Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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