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Protocol # 19-580

Status

Recruiting

Description

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.

Condition

  • Prostate Cancer

Interventions

  • Standard of Care IMRT (Photon)
  • Standard of Care Proton Therapy
  • Proton Arm 1: Standard Proton Therapy
  • Proton Arm 2: Hypofractionated Proton Therapy

Phase

N/A

Study Type

Interventional

Further Study Details

Primary Outcome:

  • Bowel urgency and bowel frequency Expanded Prostate Cancer Index Composite (EPIC) item scores

Secondary Outcome:

  • 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.
  • Freedom from biochemical progression using PSA results.

Enrollment

3000

Study Start Date

July 5, 2018

Eligibility

  • Gender:     Male
  • Minimum age:     30 Years
  • Maximum age:     85 Years
  • Healthy volunteers:     No

Sponsors

University of Florida

Source

University of Florida

Official title

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

Clinicaltrials.gov Identifier

NCT03561220

     

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.