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

Running, not enrolling · Not applicable

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT03561220

Run by

University of Florida

People needed

3000

Starts

2018-07-05

Expected to finish

2027-07-01

Last updated by the study team

2026-03-09

Who can join

Age: 30 and older, up to 85. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• University of California San Diego — La Jolla, California, United States
• Proton Therapy Treatment Center - Loma Linda University — Loma Linda, California, United States
• Sutter Health — Roseville, California, United States
• California Protons Cancer Therapy Center — San Diego, California, United States
• Department of Radiation Oncology Davis Cancer Pavilion — Gainesville, Florida, United States
• University of Florida Proton Therapy Institute — Jacksonville, Florida, United States
• Ackerman Cancer Center — Jacksonville, Florida, United States
• Mayo Clinic — Jacksonville, Florida, United States
• University of Miami School of Medicine — Miami, Florida, United States
• Miami Cancer Institute — Miami, Florida, United States
• Orlando Health UF Health Center — Orlando, Florida, United States
• Winship Cancer Institute - Emory University — Atlanta, Georgia, United States
• University of Chicago — Chicago, Illinois, United States
• Northwestern Medicine Proton Center — Warrenville, Illinois, United States
• University of Kansas Medical Center — Lawrence, Kansas, United States
• University of Louisville — Louisville, Kentucky, United States
• Willis-Knighton Medical Center PTC — Shreveport, Louisiana, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• University of Maryland — College Park, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Karmanos Cancer Institute — Detroit, Michigan, United States
• Mayo Clinic Health System — Mankato, Minnesota, United States
• Mayo Clinic — Rochester, Minnesota, United States
• S Lee Kling Proton Therapy Center - Washington University Medical Center — St Louis, Missouri, United States
• University of Alabama at Birmingham (UAB) — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.