Proton Arm 1: Standard Proton Therapy for Prostate Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Prostate CancerProton Arm 1: Standard Proton Therapy - Radiation
Eligibility
30 - 85
Male
What conditions do you have?
Select

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

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

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: Radiation
Standard Proton Therapy
Radiation
Experimental Group · 1 Intervention: Proton Arm 1: Standard Proton Therapy · Intervention Types: Radiation
IMRT (Photon)
Radiation
ActiveComparator Group · 1 Intervention: Standard of Care IMRT (Photon) · Intervention Types: Radiation
Proton Therapy Standard of Care
Radiation
ActiveComparator Group · 1 Intervention: Standard of Care Proton Therapy · Intervention Types: Radiation

Trial 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