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.
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
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
| Name | Type | Description | Interventions |
|---|
| IMRT (Photon) | Active Comparator | As this trial is pragmatic, all treatment will be standard of care. | |
| Proton Therapy Standard of Care | Active Comparator | As this trial is pragmatic, all treatment will be standard of care. | |
| Standard Proton Therapy | Experimental | 78.0 Gy (RBE) in 39 fractions. This is Arm 1 of the embedded randomized trial. | |
| Hypofractionated Proton therapy | Experimental | 60.0 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.
- 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.
- 30-85 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.
| Maximum Eligible Age: | 85 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
June 30, 2021
