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

Status
Active
Cancer Type
Prostate Cancer
Unknown Primary
Trial Phase
Eligibility
30 - 85 Years, Male
Study Type
Treatment
NCT ID
NCT03561220
Protocol IDs
COMPPARE (primary)
OCR17881
NCI-2019-03800
PCORI-6312
IRB201801001
Study Sponsor
University of Florida Health Science Center - Gainesville

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.

Objectives

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. This study includes a pre-specified
randomized comparison of standard fractionation and moderate hypofractionation dose schemes
within the proton therapy cohort. In addition, subgroup analyses will include a comparison of
outcomes by race (Black vs. White), comorbidity score (0 vs. 1+), age (<65 vs. =65),
fractionation schedule (standard, moderate, ultra-hypofractionation), and prostate cancer
aggressiveness (very low and low, intermediate, and high risk) for all objectives.

All interventions will be standard of care (SOC) radiation strategies using either IMRT or
proton therapy. All patient-reported QOL, patient-scored and patient-reported toxicity, and
disease control assessments will be SOC. Participants will also complete pretreatment surveys
regarding demographic data, personal treatment goals, factors affecting treatment
decision-making, and sources of information used in treatment selection.

Eligibility

  1. Diagnosis of adenocarcinoma of the prostate.
  2. 30-85 years of age at the time of consent with a life expectancy estimation (LEE) of = 8 years.
  3. Localized prostate cancer, as confirmed by staging with PSA, biopsy, Gleason score, DRE with or without mpMRI, and clinical stage.
  4. Very low-risk, low-risk, intermediate-risk, or high-risk disease based on NCCN Prostate Cancer Risk Group Guidelines and Joint AUA/ASTRO/SUO Guidelines.
  5. If patient has high-risk disease, nuclear medicine bone imaging must be performed to document the absence of overt metastatic disease in bones.
  6. ECOG/Zubrod Performance Status 0 - 2.
  7. Candidate for definitive prostate radiotherapy (either IMRT or proton).
  8. 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).

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
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