Study Summary
This trial compares the quality of life, toxicity, and disease control of men with prostate cancer treated with proton therapy vs. IMRT.
Eligible Conditions
- Prostate Cancer
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 3 Secondary · Reporting Duration: 3-years after the end of radiation therapy
2-years after the end of radiation therapy
Bowel urgency and bowel frequency Expanded Prostate Cancer Index Composite (EPIC) item scores
Bowel, urinary, and sexual dysfunction Expanded Prostate Cancer Index Composite (EPIC) domain scores
Grade 2 or higher toxicity for each adverse event assessed by CTCAE
Grade 2 or higher toxicity for each adverse event assessed by PRO-CTCAE.
3-years after the end of radiation therapy
Freedom from biochemical progression using PSA results.
Trial Safety
Safety Progress
Trial Design
4 Treatment Groups
IMRT (Photon)
1 of 4
Proton Therapy Standard of Care
1 of 4
Hypofractionated Proton therapy
1 of 4
Standard Proton Therapy
1 of 4
Active Control
Experimental Treatment
3000 Total Participants · 4 Treatment Groups
Primary Treatment: Proton Arm 1: Standard Proton Therapy · No Placebo Group · N/A
Hypofractionated Proton therapy
Radiation
Experimental Group · 1 Intervention: Proton Arm 2: Hypofractionated Proton Therapy · Intervention Types: RadiationStandard Proton Therapy
Radiation
Experimental Group · 1 Intervention: Proton Arm 1: Standard Proton Therapy · Intervention Types: RadiationIMRT (Photon)
Radiation
ActiveComparator Group · 1 Intervention: Standard of Care IMRT (Photon) · Intervention Types: RadiationProton Therapy Standard of Care
Radiation
ActiveComparator Group · 1 Intervention: Standard of Care Proton Therapy · Intervention Types: RadiationTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3-years after the end of radiation therapy
Who is running the clinical trial?
University of FloridaLead Sponsor
1,250 Previous Clinical Trials
695,753 Total Patients Enrolled
9 Trials studying Prostate Cancer
818 Patients Enrolled for Prostate Cancer
Patient-Centered Outcomes Research InstituteOTHER
493 Previous Clinical Trials
29,827,195 Total Patients Enrolled
6 Trials studying Prostate Cancer
20,926 Patients Enrolled for Prostate Cancer
Nancy P. Mendenhall, MDPrincipal InvestigatorUniversity of Florida
Eligibility Criteria
Age 30 - 85 · Male Participants · 8 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:If patient is to be treated with IMRT, all treatment must be planned with IMRT; if patient is to be treated with protons, all treatment must be planned with protons (including pelvic nodes if treated).
You have a diagnosis of adenocarcinoma of the prostate.
You are eligible for definitive prostate radiotherapy.
References
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- Winter M, Dokic I, Schlegel J, Warnken U, Debus J, Abdollahi A, Schnolzer M. Deciphering the Acute Cellular Phosphoproteome Response to Irradiation with X-rays, Protons and Carbon Ions. Mol Cell Proteomics. 2017 May;16(5):855-872. doi: 10.1074/mcp.M116.066597. Epub 2017 Mar 16.
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