Clinical Trials /

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

NCT03561220

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.

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: A Prospective Comparative Study of Outcomes With Proton and Photon Radiation in Prostate Cancer
  • Official Title: A Prospective Comparative Study of Outcomes With Proton and Photon Radiation in Prostate Cancer

Clinical Trial IDs

  • ORG STUDY ID: COMPPARE
  • SECONDARY ID: PCORI-6312
  • SECONDARY ID: IRB201801001
  • SECONDARY ID: OCR17881
  • NCT ID: NCT03561220

Conditions

  • Prostate Cancer

Purpose

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.

Detailed 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.
    

Trial Arms

NameTypeDescriptionInterventions
IMRT (Photon)Active ComparatorAs this trial is pragmatic, all treatment will be standard of care.
    Proton Therapy Standard of CareActive ComparatorAs this trial is pragmatic, all treatment will be standard of care.
      Standard Proton TherapyExperimental78.0 Gy (RBE) in 39 fractions. This is Arm 1 of the embedded randomized trial.
        Hypofractionated Proton therapyExperimental60.0 Gy (RBE) in 20 fractions This is Arm 2 of the embedded randomized trial.

          Eligibility Criteria

                  Inclusion Criteria:
          
                    -  Diagnosis of adenocarcinoma of the prostate.
          
                    -  Localized prostate cancer, as confirmed by staging with PSA, biopsy, Gleason score,
                       DRE, and clinical stage.
          
                    -  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.
          
                    -  30-80 years of age at the time of consent with a life expectancy estimation (LEE) of
                       ≥10 years.
          
                    -  ECOG/Zubrod Performance Status 0 - 2.
          
                  Exclusion Criteria:
          
                    -  Findings of metastatic disease (nodal or distant, N1 or M1).
          
                    -  Very low-risk or very high-risk prostate cancer based on NCCN Prostate Cancer Risk
                       Group Guidelines1 and Joint AUA/ASTRO/SUO Guidelines.51
          
                    -  Prior prostate surgical procedure, including transurethral resection of the prostate
                       (TURP) and GreenLight Laser Therapy.
          
                    -  History of invasive rectal malignancy or other pelvic malignancy, regardless of
                       disease-free interval.
          
                    -  Active inflammatory bowel disease (i.e., patients requiring medical interventions or
                       who are symptomatic) or documented history of inflammatory bowel disease requiring
                       intervention.
          
                    -  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+5 are not eligible .
                
          Maximum Eligible Age:80 Years
          Minimum Eligible Age:30 Years
          Eligible Gender:Male
          Healthy Volunteers:No

          Primary Outcome Measures

          Measure:Bowel, urinary, and sexual dysfunction Expanded Prostate Cancer Index Composite (EPIC) domain scores
          Time Frame:2-years after the end of radiation therapy
          Safety Issue:
          Description:EPIC assesses the disease-specific aspects of prostate cancer and its therapies and comprises four summary domains (Urinary, Bowel, Sexual and Hormonal). Factor analysis supports dividing the Urinary Domain Summary Score into two distinct Incontinence and Irritative/Obstructive subscales. In addition, each Domain Summary Score has measurable Function Subscale and Bother Subscale components. Response options for each EPIC item form a Likert scale, and multi-item scale scores are components. Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better HRQOL

          Secondary Outcome Measures

          Measure:Grade 2 or higher toxicity for each adverse event assessed by CTCAE
          Time Frame:2-years after the end of radiation therapy
          Safety Issue:
          Description:The NCI Common Terminology Criteria for Adverse Events v5.0 is a descriptive terminology which can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term.
          Measure:Grade 2 or higher toxicity for each adverse event assessed by PRO-CTCAE.
          Time Frame:2-years after the end of radiation therapy
          Safety Issue:
          Description:PRO-CTCAE responses are scored from 0 to 4, and there are as yet no standardized scoring rules for how to combine attributes into a single score or how best to analyse PRO-CTCAE data longitudinally. PRO-CTCAE scores for each attribute (frequency, severity and/or interference) should be presented descriptively (e.g. summary statistics or graphical presentations). CTCAE grades for the corresponding time period should be presented in conjunction with PRO-CTCAE scores.
          Measure:Freedom from biochemical progression using PSA results.
          Time Frame:3-years after the end of radiation therapy
          Safety Issue:
          Description:Biochemical failure is defined as a sustained rise in PSA of 2 ng/mL or more above the nadir (the lowest PSA level after radiotherapy).

          Details

          Phase:N/A
          Primary Purpose:Interventional
          Overall Status:Recruiting
          Lead Sponsor:University of Florida

          Trial Keywords

          • Prostate Cancer
          • Proton Radiation
          • Photon Radiation
          • Cancer of the Prostate

          Last Updated

          September 13, 2019