Prostate Cancer Clinical Trial

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

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.

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Full 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 low, intermediate, 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.

View Eligibility Criteria

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.

Study is for people with:

Prostate Cancer

Estimated Enrollment:

3000

Study ID:

NCT03561220

Recruitment Status:

Active, not recruiting

Sponsor:

University of Florida

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There are 55 Locations for this study

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University of Alabama at Birmingham (UAB)
Birmingham Alabama, 35294, United States
University of Arizona
Tucson Arizona, 85724, United States
University of California San Diego
La Jolla California, 92093, United States
Proton Therapy Treatment Center - Loma Linda University
Loma Linda California, 92354, United States
Kaiser Permanente
Los Angeles California, 90027, United States
Sutter Health
Roseville California, 95661, United States
California Protons Cancer Therapy Center
San Diego California, 92121, United States
Department of Radiation Oncology Davis Cancer Pavilion
Gainesville Florida, 32611, United States
University of Florida Proton Therapy Institute
Jacksonville Florida, 32206, United States
Ackerman Cancer Center
Jacksonville Florida, 32223, United States
Mayo Clinic
Jacksonville Florida, 32224, United States
University of Miami School of Medicine
Miami Florida, 33136, United States
Miami Cancer Institute
Miami Florida, 33176, United States
Orlando Health UF Health Center
Orlando Florida, 32806, United States
Winship Cancer Institute - Emory University
Atlanta Georgia, 30322, United States
University of Chicago
Chicago Illinois, 60637, United States
Northwestern Medicine Proton Center
Warrenville Illinois, 60555, United States
University of Kansas Medical Center
Lawrence Kansas, 66045, United States
University of Louisville
Louisville Kentucky, 40292, United States
Willis-Knighton Medical Center PTC
Shreveport Louisiana, 71103, United States
Johns Hopkins University
Baltimore Maryland, 21218, United States
University of Maryland
College Park Maryland, 20742, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Mayo Clinic Health System
Mankato Minnesota, 56001, United States
Mayo Clinic
Rochester Minnesota, 55905, United States
S Lee Kling Proton Therapy Center - Washington University Medical Center
Saint Louis Missouri, 63110, United States
Rutgers Cancer Institute of New Jersey
New Brunswick New Jersey, 08901, United States
ProCure Proton Therapy Center
Somerset New Jersey, 08873, United States
New York Proton Center
New York New York, 10035, United States
Weill Cornell
New York New York, 10065, United States
The Duke University Health System
Durham North Carolina, 27705, United States
UNC- Rex Hospital
Raleigh North Carolina, 27607, United States
University of Cincinnati Medical PTC
Cincinnati Ohio, 45267, United States
Cleveland Clinic
Cleveland Ohio, 44106, United States
University Hospitals- Seidman Cancer Center
Cleveland Ohio, 44106, United States
Stephenson Cancer Center
Oklahoma City Oklahoma, 73104, United States
Oregon Health & Science University
Portland Oregon, 97201, United States
University of Pennsylvania--Penn Medicine
Philadelphia Pennsylvania, 19104, United States
Thomas Jefferson University
Philadelphia Pennsylvania, 19144, United States
Medical University of South Carolina
Charleston South Carolina, 29407, United States
Mabry Center for Cancer Care
Orangeburg South Carolina, 29118, United States
Provision CARES Proton Therapy Center Knoxville
Knoxville Tennessee, 37909, United States
Texas Oncology
Austin Texas, 78731, United States
University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States
Texas Center for Proton Therapy
Irving Texas, 75063, United States
Texas Oncology - Longview
Longview Texas, 75601, United States
Texas Oncology - McKinney
McKinney Texas, 75071, United States
Texas Oncology - Plano West
Plano Texas, 75093, United States
Texas Oncology - Waco
Waco Texas, 76712, United States
University of Virginia
Charlottesville Virginia, 22904, United States
Inova Schar Cancer Institute
Fairfax Virginia, 22031, United States
Hampton University Proton Therapy Institute
Hampton Virginia, 23666, United States
Seattle Care Alliance/University of Washington
Seattle Washington, 98133, United States
Mayo Clinic Health System
Eau Claire Wisconsin, 54703, United States
Mayo Clinic Health System-Franciscan Healthcare
Sparta Wisconsin, 54656, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Estimated Enrollment:

3000

Study ID:

NCT03561220

Recruitment Status:

Active, not recruiting

Sponsor:


University of Florida

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