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Proton vs. X-Ray: which prostate cancer treatment is kinder?

NCT ID NCT01617161

Symptom relief Sponsor: Massachusetts General Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two types of radiation therapy for low- or intermediate-risk prostate cancer: proton therapy (PBT) and intensity-modulated radiation therapy (IMRT). Both are thought to be equally effective at treating the cancer, but it's unclear which causes fewer side effects like bowel, urinary, or erectile problems. About 450 men are participating to see which treatment better preserves quality of life two years after treatment.

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

454 people

The number who actually took part.

Started

Jul 2012

Expected to finish

Dec 2030

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

18 years and older

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: * Diagnosed with histologically confirmed adenocarcinoma of the prostate based on core-biopsy within 1 year of study entry from TRUS * Clinical stages T1c to T2c * PSA \<20, within 6 months of study entry * Participants who are currently receiving Dutasteride (or have received it within the last 90 days) or Finasteride (or have received it within the last 30 days) must have a PSA of ≤ 10 * Gleason score ≤6, 3 + 4 = 7, or 4 + 3 = 7 * ECOG Performance Status 0-1 as documented within 3 months prior to study entry * Must have complete history and physical examination within 45 days of study entry and digital rectal examination of prostate within 180 days of study entry Exclusion Criteria: * Prior surgery (not including TURP), cryosurgery, radiofrequency ablation, chemotherapy or radiation for PCa * Prior or planned androgen deprivation or bilateral orchiectomy * Distant metastases, or clinically or pathologically involved lymph nodes confirmed by a CT scan within 365 days of study entry * Hip prosthesis, inflammatory bowel disease or connective tissue disorder such as active scleroderma or lupus * Individuals with a history of other malignancies are ineligible unless 1) they have been disease-free for at least 5 years OR 2) are deemed by the investigator to be at low risk for recurrence of that malignancy with no plans for adjuvant systemic chemotherapy and/or radiation therapy and have received overall principal investigator approval. * Individuals who have AIDS (CD4 \< 200 or an AIDS-defining illness) or are HIV positive and not on HAART therapy are ineligible. * Major medical or psychiatric illness * Individuals with any of the following conditions are excluded from this study: * Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months. * Transmural myocardial infarction within the last 6 months. * Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration. * Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration * History of Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects within the last 12 months

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Conditions

The condition(s) this trial relates to.

prostate adenocarcinoma 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

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • Mass General/North Shore Cancer Center

    Danvers, Massachusetts, 01923, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Northwestern Medicine Chicago Proton Center

    Chicago, Illinois, 60190, United States

  • Princeton ProCure Proton Therapy Center

    Somerset, New Jersey, 08873, United States

  • Provision Proton Therapy Center

    Knoxville, Tennessee, 37909, United States

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903, United States

  • University Hospital of Cleveland

    Cleveland, Ohio, 44106, United States

  • University of Florida Health Proton Therapy Institute

    Jacksonville, Florida, 32206, United States

  • University of Maryland Medical Center

    College Park, Maryland, 20742, United States

  • University of Washington Medical Center

    Seattle, Washington, 98195, United States

  • Washington University

    St Louis, Missouri, 63110, United States

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