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

  • STATUS
    Recruiting
  • End date
    Apr 1, 2023
  • participants needed
    3000
  • sponsor
    University of Florida
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Updated on 28 January 2021
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metastasis
bone scan
adenocarcinoma
adenocarcinoma of prostate

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.

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. Pre-specified subset comparators include a randomized comparison of standard fractionation and moderate hypofractionation dose schemes within the proton therapy cohort. In addition, analysis of heterogeneous treatment effects (HTE) will include a comparison of outcomes by race (Black vs. White), comorbidity score (0 vs. 1+), age (65 vs. >65), and prostate cancer aggressiveness (low, intermediate, and high risk) for all endpoints.

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.

Details
Condition Malignant neoplasm of prostate, Prostatic disorder, Prostate Disorders, Prostate Cancer, Early, Recurrent, Prostate Cancer, prostate carcinoma, prostate cancers
Treatment Standard of Care IMRT (Photon), Standard of Care Proton Therapy, Proton Arm 1: Standard Proton Therapy, Proton Arm 2: Hypofractionated Proton Therapy
Clinical Study IdentifierNCT03561220
SponsorUniversity of Florida
Last Modified on28 January 2021

Eligibility

 Yes No Not Sure

Inclusion Criteria

Is your age between 30 yrs and 85 yrs?
Are you male?
Do you have any of these conditions: Prostate Cancer or Prostate Disorders or Prostatic disorder or Prostate Cancer, Early, Recurrent or Malignant neoplasm of prostate?
Do you have any of these conditions: prostate cancers or Prostate Disorders or Prostate Cancer or Malignant neoplasm of prostate or prostate carcinoma or Prostate Cancer, Early, Recurrent...?
Do you have any of these conditions: Prostatic disorder or prostate carcinoma or Prostate Disorders or Prostate Cancer or Malignant neoplasm of prostate or Prostate Cancer, Early, Recurre...?
Do you have any of these conditions: Prostate Cancer or Prostate Cancer, Early, Recurrent or Malignant neoplasm of prostate or Prostate Disorders or prostate carcinoma or Prostatic disord...?
Diagnosis of adenocarcinoma of the prostate
Localized prostate cancer, as confirmed by staging with PSA, biopsy, Gleason score, DRE, and clinical stage
Very low-risk, Low-risk, intermediate-risk, or high-risk disease based on NCCN Prostate Cancer Risk Group Guidelines1 and Joint AUA/ASTRO/SUO Guidelines.51
If patient has high-risk disease, nuclear medicine bone imaging must be performed to document the absence of overt metastatic disease in bones
Candidate for definitive prostate radiotherapy (either IMRT or proton)
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)
No previous prostate cancer treatment with the exception of ADT according to NCCN guidelines
-85 years of age at the time of consent with a life expectancy estimation (LEE) of 8 years
ECOG/Zubrod Performance Status 0 - 2

Exclusion Criteria

Findings of metastatic disease (nodal or distant, N1 or M1)
Very high-risk prostate cancer based on NCCN Prostate Cancer Risk Group Guidelines1 and Joint AUA/ASTRO/SUO Guidelines.51
Prior prostate surgical procedure
History of invasive rectal malignancy or other pelvic malignancy, regardless of disease-free interval
Prior pelvic RT for any reason
Documented lack of psychological ability or general health permitting completion of the study requirements and required follow-up
Documented diminished capacity to understand the risks and benefits of participation in research and to autonomously provide informed consent
In addition, because the embedded randomized controlled trial compares
fractionation schemes, patients who are receiving pelvic node irradiation may
not be enrolled on the randomized controlled trial, as well as, Gleason 5+4 or
+5 are not eligible
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