Clinical trial NCT03561220: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Proton Radiation
Photon Radiation
Cancer of the Prostate
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2018-06-19
Enrollment: 3000
Sex: MALE
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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. 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 criteria: Inclusion Criteria:

* Diagnosis of adenocarcinoma of the prostate.
* 30-85 years of age at the time of consent with a life expectancy estimation (LEE) of ≥ 8 years.
* Localized prostate cancer, as confirmed by staging with PSA, biopsy, Gleason score, DRE with or without mpMRI, and clinical stage.
* 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.
* If patient has high-risk disease, nuclear medicine bone imaging must be performed to document the absence of overt metastatic disease in bones.
* ECOG/Zubrod Performance Status 0 - 2.
* 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).

Exclusion Criteria:

* Findings of metastatic disease (nodal or distant, N1 or M1).
* Very high-risk prostate cancer based on NCCN Prostate Cancer Risk Group Guidelines and Joint AUA/ASTRO/SUO Guidelines.
* Prior procedures for treatment of prostate cancer, such as radical or robotic prostatectomy, high-intensity focused ultrasound, cryosurgery, or focal prostatectomy \[note that procedures used for benign prostatic hyperplasia symptoms, such as transurethral resection of the prostate (TURP) and GreenLight Laser Therapy, are acceptable\].
* Previous prostate cancer treatment with the exception of ADT according to NCCN guidelines.
* History of invasive rectal malignancy or other malignancy in the true pelvis (e.g. bladder, rectum, or reproductive organs), regardless of disease-free interval.
* Active inflammatory bowel disease (i.e., patients requiring medical interventions or who are symptomatic).
* 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.

Primary outcomes:
measure: Bowel urgency and bowel frequency Expanded Prostate Cancer Index Composite (EPIC) item scores
timeFrame: 2-years after the end of radiation therapy
Secondary outcomes:
measure: Grade 2 or higher toxicity for each adverse event assessed by CTCAE
timeFrame: 2-years after the end of radiation therapy
measure: Grade 2 or higher toxicity for each adverse event assessed by PRO-CTCAE.
timeFrame: 2-years after the end of radiation therapy
measure: Freedom from biochemical progression using PSA results.
timeFrame: 3-years after the end of radiation therapy
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham (UAB)
state: Alabama
city: La Jolla
country: United States
facility: University of California San Diego
state: California
city: Loma Linda
country: United States
facility: Proton Therapy Treatment Center - Loma Linda University
state: California
city: Roseville
country: United States
facility: Sutter Health
state: California
city: San Diego
country: United States
facility: California Protons Cancer Therapy Center
state: California
city: Gainesville
country: United States
facility: Department of Radiation Oncology Davis Cancer Pavilion
state: Florida
city: Jacksonville
country: United States
facility: University of Florida Proton Therapy Institute
state: Florida
city: Jacksonville
country: United States
facility: Ackerman Cancer Center
state: Florida
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Miami
country: United States
facility: University of Miami School of Medicine
state: Florida
city: Miami
country: United States
facility: Miami Cancer Institute
state: Florida
city: Orlando
country: United States
facility: Orlando Health UF Health Center
state: Florida
city: Atlanta
country: United States
facility: Winship Cancer Institute - Emory University
state: Georgia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Warrenville
country: United States
facility: Northwestern Medicine Proton Center
state: Illinois
city: Lawrence
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Shreveport
country: United States
facility: Willis-Knighton Medical Center PTC
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: College Park
country: United States
facility: University of Maryland
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Mankato
country: United States
facility: Mayo Clinic Health System
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: S Lee Kling Proton Therapy Center - Washington University Medical Center
state: Missouri
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
city: Somerset
country: United States
facility: Covenant Health
state: New Jersey
city: New York
country: United States
facility: New York Proton Center
state: New York
city: New York
country: United States
facility: Weill Cornell
state: New York
city: Durham
country: United States
facility: The Duke University Health System
state: North Carolina
city: Raleigh
country: United States
facility: UNC- Rex Hospital
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati Medical PTC
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals- Seidman Cancer Center
state: Ohio
city: Oklahoma City
country: United States
facility: Stephenson Cancer Center
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania--Penn Medicine
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Knoxville
country: United States
facility: Provision CARES Proton Therapy Center Knoxville
state: Tennessee
city: Austin
country: United States
facility: Texas Oncology
state: Texas
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
city: Irving
country: United States
facility: Texas Center for Proton Therapy
state: Texas
city: Longview
country: United States
facility: Texas Oncology - Longview
state: Texas
city: McKinney
country: United States
facility: Texas Oncology - McKinney
state: Texas
city: Plano
country: United States
facility: Texas Oncology - Plano West
state: Texas
city: Waco
country: United States
facility: Texas Oncology - Waco
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Fairfax
country: United States
facility: Inova Schar Cancer Institute
state: Virginia
city: Hampton
country: United States
facility: Hampton University Proton Therapy Institute
state: Virginia
city: Seattle
country: United States
facility: Seattle Care Alliance/University of Washington
state: Washington
city: Eau Claire
country: United States
facility: Mayo Clinic Health System
state: Wisconsin
city: Sparta
country: United States
facility: Mayo Clinic Health System-Franciscan Healthcare
state: Wisconsin
Study officials:
affiliation: University of Florida
name: Nancy P. Mendenhall, MD
role: PRINCIPAL_INVESTIGATOR
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