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Prostate CancerCOMPPARENCT03561220

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

A study testing Proton Arm 1: Standard Proton Therapy and Proton Arm 2: Hypofractionated Proton Therapy in people with Prostate Cancer, run by University of Florida at 53 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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)… Read more about this study

Who is it for?
Ages 30 to 85 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Proton Arm 1: Standard Proton Therapy and Proton Arm 2: Hypofractionated Proton Therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,000 participants
Where
53 sitesUnited States
Study dates
5 Jul 2018to 1 Jul 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 85 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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).
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  • 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.

Trial locations and contacts

53 sites in 1 country.

53 sites in 1 country

United States53 sites

  • Winship Cancer Institute - Emory University

    Atlanta, Georgia, 30322

  • Texas Oncology

    Austin, Texas, 78731

  • Johns Hopkins University

    Baltimore, Maryland, 21218

  • University of Alabama at Birmingham (UAB)

    Birmingham, Alabama, 35294

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Medical University of South Carolina

    Charleston, South Carolina, 29407

  • University of Virginia

    Charlottesville, Virginia, 22904

  • University of Chicago

    Chicago, Illinois, 60637

  • University of Cincinnati Medical PTC

    Cincinnati, Ohio, 45267

  • Cleveland Clinic

    Cleveland, Ohio, 44106

  • University Hospitals- Seidman Cancer Center

    Cleveland, Ohio, 44106

  • University of Maryland

    College Park, Maryland, 20742

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • The Duke University Health System

    Durham, North Carolina, 27705

  • Mayo Clinic Health System

    Eau Claire, Wisconsin, 54703

  • Inova Schar Cancer Institute

    Fairfax, Virginia, 22031

  • Department of Radiation Oncology Davis Cancer Pavilion

    Gainesville, Florida, 32611

  • Hampton University Proton Therapy Institute

    Hampton, Virginia, 23666

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Texas Center for Proton Therapy

    Irving, Texas, 75063

  • University of Florida Proton Therapy Institute

    Jacksonville, Florida, 32206

  • Ackerman Cancer Center

    Jacksonville, Florida, 32223

  • Mayo Clinic

    Jacksonville, Florida, 32224

  • Covenant Health Proton Center

    Knoxville, Tennessee, 37909

  • University of California San Diego

    La Jolla, California, 92093

  • University of Kansas Medical Center

    Lawrence, Kansas, 66045

  • Proton Therapy Treatment Center - Loma Linda University

    Loma Linda, California, 92354

  • Texas Oncology - Longview

    Longview, Texas, 75601

  • University of Louisville

    Louisville, Kentucky, 40292

  • Mayo Clinic Health System

    Mankato, Minnesota, 56001

  • Texas Oncology - McKinney

    McKinney, Texas, 75071

  • University of Miami School of Medicine

    Miami, Florida, 33136

  • Miami Cancer Institute

    Miami, Florida, 33176

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901

  • New York Proton Center

    New York, New York, 10035

  • Weill Cornell

    New York, New York, 10065

  • Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104

  • Orlando Health UF Health Center

    Orlando, Florida, 32806

  • University of Pennsylvania--Penn Medicine

    Philadelphia, Pennsylvania, 19104

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19144

  • Texas Oncology - Plano West

    Plano, Texas, 75093

  • Oregon Health & Science University

    Portland, Oregon, 97201

  • UNC- Rex Hospital

    Raleigh, North Carolina, 27607

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Sutter Health

    Roseville, California, 95661

  • California Protons Cancer Therapy Center

    San Diego, California, 92121

  • Seattle Care Alliance/University of Washington

    Seattle, Washington, 98133

  • Willis-Knighton Medical Center PTC

    Shreveport, Louisiana, 71103

  • Covenant Health

    Somerset, New Jersey, 08873

  • Mayo Clinic Health System-Franciscan Healthcare

    Sparta, Wisconsin, 54656

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

    St Louis, Missouri, 63110

  • Texas Oncology - Waco

    Waco, Texas, 76712

  • Northwestern Medicine Proton Center

    Warrenville, Illinois, 60555

Other trials in United States

About this study

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.

Read the 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.

Conditions
Prostate Cancer
Being tested
Standard of Care IMRT (Photon), Standard of Care Proton Therapy, Proton Arm 1: Standard Proton Therapy, Proton Arm 2: Hypofractionated Proton Therapy
Keywords
Prostate Cancer, Proton Radiation, Photon Radiation, Cancer of the Prostate
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standard of Care IMRT (Photon)Radiation

    As this trial is pragmatic, all treatment will be standard of care.

  • Standard of Care Proton TherapyRadiation

    As this trial is pragmatic, all treatment will be standard of care.

  • Proton Arm 1: Standard Proton TherapyRadiation

    78.0 Gy (RBE) in 39 fractions

  • Proton Arm 2: Hypofractionated Proton TherapyRadiation

    60.0 Gy (RBE) in 20 fractions

Study groups in NCT03561220
Study groupRoleWhat they receive
IMRT (Photon)Active comparatorAs this trial is pragmatic, all treatment will be standard of care.
Receives: Radiation: Standard of Care IMRT (Photon)
Proton Therapy Standard of CareActive comparatorAs this trial is pragmatic, all treatment will be standard of care.
Receives: Radiation: Standard of Care Proton Therapy
Standard Proton TherapyExperimental78.0 Gy (RBE) in 39 fractions. This is Arm 1 of the embedded randomized trial.
Receives: Radiation: Proton Arm 1: Standard Proton Therapy
Hypofractionated Proton therapyExperimental60.0 Gy (RBE) in 20 fractions This is Arm 2 of the embedded randomized trial.
Receives: Radiation: Proton Arm 2: Hypofractionated Proton Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Bowel urgency and bowel frequency Expanded Prostate Cancer Index Composite (EPIC) item scores

    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

    Measured: 2-years after the end of radiation therapy

Secondary outcomes (3)

  1. Grade 2 or higher toxicity for each adverse event assessed by CTCAE

    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.

    Measured: 2-years after the end of radiation therapy

  2. Grade 2 or higher toxicity for each adverse event assessed by PRO-CTCAE.

    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.

    Measured: 2-years after the end of radiation therapy

  3. Freedom from biochemical progression using PSA results.

    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).

    Measured: 3-years after the end of radiation therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jun 2018
  2. Study start5 Jul 2018
  3. Primary completion15 Feb 2026
  4. Study completion1 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
3,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03561220
Sponsor's protocol ID
COMPPARE
Other IDs
PCORI-6312, IRB201801001, OCR17881
Acronym
COMPPARE
Status last verified
Aug 2025
First submitted
15 May 2018
Last updated
9 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • NCCN Clinical Practical Guidelines in Oncology: Prostate Cancer. Version 2. 2018.

  • AJCC Cancer Staging Manual. 8th ed. Cham, Switzerland: Springer International Publishing; 2017.

  • Siegel RL, Miller KD, Jemal A. Cancer Statistics, 2017. CA Cancer J Clin. 2017 Jan;67(1):7-30. doi: 10.3322/caac.21387. Epub 2017 Jan 5.

    PubMed 28055103

  • U.S. Preventive Services Task Force. Draft Recommendation Statement: Prostate Cancer: Screening. April 2017; https://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementDraft/prostate-cancer-screening1. Accessed May 8, 2017.

  • Chen RC, Clark JA, Talcott JA. Individualizing quality-of-life outcomes reporting: how localized prostate cancer treatments affect patients with different levels of baseline urinary, bowel, and sexual function. J Clin Oncol. 2009 Aug 20;27(24):3916-22. doi: 10.1200/JCO.2008.18.6486. Epub 2009 Jul 20.

    PubMed 19620493

  • Sanda MG, Dunn RL, Michalski J, Sandler HM, Northouse L, Hembroff L, Lin X, Greenfield TK, Litwin MS, Saigal CS, Mahadevan A, Klein E, Kibel A, Pisters LL, Kuban D, Kaplan I, Wood D, Ciezki J, Shah N, Wei JT. Quality of life and satisfaction with outcome among prostate-cancer survivors. N Engl J Med. 2008 Mar 20;358(12):1250-61. doi: 10.1056/NEJMoa074311.

    PubMed 18354103

  • Stokes ME, Ishak J, Proskorovsky I, Black LK, Huang Y. Lifetime economic burden of prostate cancer. BMC Health Serv Res. 2011 Dec 28;11:349. doi: 10.1186/1472-6963-11-349.

    PubMed 22204308

  • Riley GF, Potosky AL, Lubitz JD, Kessler LG. Medicare payments from diagnosis to death for elderly cancer patients by stage at diagnosis. Med Care. 1995 Aug;33(8):828-41. doi: 10.1097/00005650-199508000-00007.

    PubMed 7637404

  • Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90. doi: 10.3322/caac.20107. Epub 2011 Feb 4.

    PubMed 21296855

  • Gray PJ, Lin CC, Cooperberg MR, Jemal A, Efstathiou JA. Temporal Trends and the Impact of Race, Insurance, and Socioeconomic Status in the Management of Localized Prostate Cancer. Eur Urol. 2017 May;71(5):729-737. doi: 10.1016/j.eururo.2016.08.047. Epub 2016 Sep 3.

    PubMed 27597241

  • Miller KD, Siegel RL, Lin CC, Mariotto AB, Kramer JL, Rowland JH, Stein KD, Alteri R, Jemal A. Cancer treatment and survivorship statistics, 2016. CA Cancer J Clin. 2016 Jul;66(4):271-89. doi: 10.3322/caac.21349. Epub 2016 Jun 2.

    PubMed 27253694

  • Chamie K, Williams SB, Hu JC. Population-Based Assessment of Determining Treatments for Prostate Cancer. JAMA Oncol. 2015 Apr;1(1):60-7. doi: 10.1001/jamaoncol.2014.192.

    PubMed 26182305

  • Hamdy FC, Donovan JL, Lane JA, Mason M, Metcalfe C, Holding P, Davis M, Peters TJ, Turner EL, Martin RM, Oxley J, Robinson M, Staffurth J, Walsh E, Bollina P, Catto J, Doble A, Doherty A, Gillatt D, Kockelbergh R, Kynaston H, Paul A, Powell P, Prescott S, Rosario DJ, Rowe E, Neal DE; ProtecT Study Group. 10-Year Outcomes after Monitoring, Surgery, or Radiotherapy for Localized Prostate Cancer. N Engl J Med. 2016 Oct 13;375(15):1415-1424. doi: 10.1056/NEJMoa1606220. Epub 2016 Sep 14.

    PubMed 27626136

  • Zietman A. Proton beam and prostate cancer: An evolving debate. Rep Pract Oncol Radiother. 2013 Jul 3;18(6):338-42. doi: 10.1016/j.rpor.2013.06.001.

    PubMed 24416575

  • Wisenbaugh ES, Andrews PE, Ferrigni RG, Schild SE, Keole SR, Wong WW, Vora SA. Proton beam therapy for localized prostate cancer 101: basics, controversies, and facts. Rev Urol. 2014;16(2):67-75.

    PubMed 25009446

Questions about this trial

What is this clinical trial studying?

A study testing Proton Arm 1: Standard Proton Therapy and Proton Arm 2: Hypofractionated Proton Therapy in people with Prostate Cancer, run by University of Florida at 53 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bowel urgency and bowel frequency Expanded Prostate Cancer Index Composite (EPIC) item scores (time frame: 2-years after the end of radiation therapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03561220, which also lists 26 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.

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