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A Prospective Comparative Study of Outcomes With Proton and Photon Radiation in Prostate Cancer

NCT03561220 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3000

Last updated 2026-03-09

No results posted yet for this study

Summary

This study is a large, prospective, pragmatic, controlled comparison of patient-centric outcomes \[quality of life (QOL), toxicity, and disease control\] between parallel cohorts of men with prostate cancer treated simultaneously at proton therapy facilities and at geographically similar conventional (photon-based) radiation facilities using intensity-modulated radiation therapy (IMRT) techniques.

Conditions

Interventions

RADIATION

Standard of Care IMRT (Photon)

As this trial is pragmatic, all treatment will be standard of care.

RADIATION

Standard of Care Proton Therapy

As this trial is pragmatic, all treatment will be standard of care.

RADIATION

Proton Arm 1: Standard Proton Therapy

78.0 Gy (RBE) in 39 fractions

RADIATION

Proton Arm 2: Hypofractionated Proton Therapy

60.0 Gy (RBE) in 20 fractions

Sponsors & Collaborators

  • Patient-Centered Outcomes Research Institute

    collaborator OTHER

  • University of Florida

    lead OTHER

Principal Investigators

  • Nancy P. Mendenhall, MD · University of Florida

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
85 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-05
Primary Completion
2026-02-15
Completion
2027-07-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03561220 on ClinicalTrials.gov