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Proton vs. photon: which radiation is kinder to prostate cancer patients?

NCT ID NCT03561220

Disease control Sponsor: University of Florida Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study follows 3000 men with prostate cancer to compare how proton therapy and standard photon radiation affect quality of life and side effects like bowel urgency. Participants receive standard care at proton or photon centers, and researchers track bowel, urinary, and sexual function over time. The goal is to help patients and doctors choose the best radiation option.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
radiation therapy (proton or photon)
What this could lead to
If it works, this could show which type of radiation causes fewer bowel side effects and better quality of life for men with prostate cancer.
What could go wrong
This is an observational comparison, not a randomized trial, so results may be influenced by patient differences. It is also not testing a new treatment, just comparing existing ones.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 3,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2018

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

30 to 85 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

prostate cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostate cancer

Contacts and locations

Locations

  • Ackerman Cancer Center

    Jacksonville, Florida, 32223, United States

  • California Protons Cancer Therapy Center

    San Diego, California, 92121, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44106, United States

  • Covenant Health

    Somerset, New Jersey, 08873, United States

  • Covenant Health Proton Center

    Knoxville, Tennessee, 37909, United States

  • Department of Radiation Oncology Davis Cancer Pavilion

    Gainesville, Florida, 32611, United States

  • Hampton University Proton Therapy Institute

    Hampton, Virginia, 23666, United States

  • Inova Schar Cancer Institute

    Fairfax, Virginia, 22031, United States

  • Johns Hopkins University

    Baltimore, Maryland, 21218, United States

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Mayo Clinic Health System

    Mankato, Minnesota, 56001, United States

  • Mayo Clinic Health System

    Eau Claire, Wisconsin, 54703, United States

  • Mayo Clinic Health System-Franciscan Healthcare

    Sparta, Wisconsin, 54656, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29407, United States

  • Miami Cancer Institute

    Miami, Florida, 33176, United States

  • New York Proton Center

    New York, New York, 10035, United States

  • Northwestern Medicine Proton Center

    Warrenville, Illinois, 60555, United States

  • Oregon Health & Science University

    Portland, Oregon, 97201, United States

  • Orlando Health UF Health Center

    Orlando, Florida, 32806, United States

  • Proton Therapy Treatment Center - Loma Linda University

    Loma Linda, California, 92354, United States

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901, United States

  • S Lee Kling Proton Therapy Center - Washington University Medical Center

    St Louis, Missouri, 63110, United States

  • Seattle Care Alliance/University of Washington

    Seattle, Washington, 98133, United States

  • Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104, United States

  • Sutter Health

    Roseville, California, 95661, United States

  • Texas Center for Proton Therapy

    Irving, Texas, 75063, United States

  • Texas Oncology

    Austin, Texas, 78731, 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

  • The Duke University Health System

    Durham, North Carolina, 27705, United States

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19144, United States

  • UNC- Rex Hospital

    Raleigh, North Carolina, 27607, United States

  • University Hospitals- Seidman Cancer Center

    Cleveland, Ohio, 44106, United States

  • University of Alabama at Birmingham (UAB)

    Birmingham, Alabama, 35294, United States

  • University of California San Diego

    La Jolla, California, 92093, United States

  • University of Chicago

    Chicago, Illinois, 60637, United States

  • University of Cincinnati Medical PTC

    Cincinnati, Ohio, 45267, United States

  • University of Florida Proton Therapy Institute

    Jacksonville, Florida, 32206, United States

  • University of Kansas Medical Center

    Lawrence, Kansas, 66045, United States

  • University of Louisville

    Louisville, Kentucky, 40292, United States

  • University of Maryland

    College Park, Maryland, 20742, United States

  • University of Miami School of Medicine

    Miami, Florida, 33136, United States

  • University of Pennsylvania--Penn Medicine

    Philadelphia, Pennsylvania, 19104, United States

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • University of Virginia

    Charlottesville, Virginia, 22904, United States

  • Weill Cornell

    New York, New York, 10065, United States

  • Willis-Knighton Medical Center PTC

    Shreveport, Louisiana, 71103, United States

  • Winship Cancer Institute - Emory University

    Atlanta, Georgia, 30322, United States

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