Proton Therapy vs. IMRT for Low or Intermediate Risk Prostate Cancer
NCT ID: NCT01617161
Last Updated: 2026-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
454 participants
INTERVENTIONAL
2012-07-25
2030-12-31
Brief Summary
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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.
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Detailed Description
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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) for up to 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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PBT
Proton Beam Therapy
Proton Beam Therapy
5 days per week up to 9 weeks
IMRT
Intensity Modulated Radiation Therapy
Intensity Modulated Radiation Therapy
5 times per week up to 9 weeks
Interventions
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Proton Beam Therapy
5 days per week up to 9 weeks
Intensity Modulated Radiation Therapy
5 times per week up to 9 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
MALE
No
Sponsors
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University of Pennsylvania
OTHER
National Cancer Institute (NCI)
NIH
Northwestern Medicine Chicago Proton Center
UNKNOWN
ProCure Proton Therapy Center
OTHER
Washington University School of Medicine
OTHER
University of Washington
OTHER
Rutgers Cancer Institute of New Jersey
OTHER
Mayo Clinic
OTHER
University of Maryland, Baltimore
OTHER
University Hospitals Cleveland Medical Center
OTHER
University of Florida Proton Therapy Institute
UNKNOWN
Provision Center for Proton Therapy
OTHER
Massachusetts General Hospital
OTHER
Responsible Party
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Jason Efstathiou
Principal Investigator
Principal Investigators
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Jason A Efstathiou, MD, DPhil
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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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
Countries
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References
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Liu Y, Patel SA, Jani AB, Gillespie TW, Patel PR, Godette KD, Hershatter BW, Shelton JW, McDonald MW. Overall Survival After Treatment of Localized Prostate Cancer With Proton Beam Therapy, External-Beam Photon Therapy, or Brachytherapy. Clin Genitourin Cancer. 2021 Jun;19(3):255-266.e7. doi: 10.1016/j.clgc.2020.08.009. Epub 2020 Aug 28.
Other Identifiers
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11-497
Identifier Type: -
Identifier Source: org_study_id
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