Hypofractionated Proton Radiation Therapy for Low and Intermediate Risk Prostate Cancer
NCT ID: NCT01368055
Last Updated: 2025-08-29
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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COMPLETED
NA
361 participants
INTERVENTIONAL
2011-09-30
2025-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Low Risk
70 Gy/CGE
70 Gy/CGE
Low Risk
Intermediate Risk
72.5 Gy/CGE
72.5 Gy/CGE
Intermediate Risk
Interventions
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70 Gy/CGE
Low Risk
72.5 Gy/CGE
Intermediate Risk
Eligibility Criteria
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Inclusion Criteria
* Gleason score 2-6 or 7.
* PSA ≤ 20 ng/ml.
Exclusion Criteria
* Prior/concurrent systemic chemotherapy for prostate cancer.
* Active inflammatory bowel disease (Crohn's disease, diverticulitis or ulcerative colitis) affecting the rectum.
* History of hip replacement.
* Prior intrapelvic surgery.
* Taking Saw Palmetto or methotrexate and unable or unwilling to discontinue its uses during radiation.
* Receiving continuous and current anticoagulation with Warfarin sodium (Coumadin), Clopidogrel bisulfate (Plavix), dabigatran etexilate mesylate (Pradaxa),enoxaparin sodium (Lovenox), or aspirin/er dipyridamole (Aggrenox).
18 Years
MALE
No
Sponsors
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University of Florida
OTHER
Responsible Party
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Principal Investigators
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Curtis Bryant, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of Florida Proton Therapy Institute
Locations
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University of Florida Proton Therapy Institute
Jacksonville, Florida, United States
Countries
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References
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American Cancer Society. 2010. Ref Type: Electronic Citation
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Related Links
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(Contact the University of Florida Proton Therapy Institute)
Other Identifiers
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IRB201701768
Identifier Type: OTHER
Identifier Source: secondary_id
UFPTI 1103-PR07
Identifier Type: -
Identifier Source: org_study_id
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