Proton Therapy vs. IMRT for Low or Intermediate Risk Prostate Cancer (NCT01617161)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (14 items).
Location: University of Florida Health Proton Therapy Institute — Jacksonville, Florida
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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
- 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.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (13 Sites)
- University of Florida Health Proton Therapy Institute — Jacksonville, Florida
- Northwestern Medicine Chicago Proton Center — Chicago, Illinois
- University of Maryland Medical Center — College Park, Maryland
- Massachusetts General Hospital — Boston, Massachusetts
- Mass General/North Shore Cancer Center — Danvers, Massachusetts
- Mayo Clinic — Rochester, Minnesota
- Washington University — St Louis, Missouri
- Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey
- Princeton ProCure Proton Therapy Center — Somerset, New Jersey
- University Hospital of Cleveland — Cleveland, Ohio
- Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania
- Provision Proton Therapy Center — Knoxville, Tennessee
- University of Washington Medical Center — Seattle, Washington
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.