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Proton beam therapy aims for safer prostate cancer treatment

NCT ID NCT04842890

Disease control Sponsor: The New York Proton Center 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests a precise form of proton radiation for men with low- or intermediate-risk prostate cancer. The goal is to see if this approach causes fewer severe side effects than standard X-ray-based radiation. About 61 men will receive 5 treatments over 10 days and be monitored for 2 years.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

61 people

The number who actually took part.

Started

Jan 2021

Expected to finish

Jan 2031

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: * Biopsy-proven NCCN low- or intermediate-risk prostate cancer, which includes patients with: * Gleason score ≤7 disease * PSA ≤20 ng/ml * Clinical T1-T2c disease * Note: Patients who only have radiographic evidence of possible or probable T3 disease (i.e., extracapsular extension or seminal vesical invasion) will not be excluded. * KPS ≥ 80% * Prostate size as determined on MRI to be \< 100 cc. Prostate size can be determined on CT scan if MRI is not available. * Male 18 years of age or older * IPSS ≤ 20 * Patient must be a candidate for and agree to placement of intraprostatic fiducial markers and a hydrogel rectal spacer * Patient must be available for at least 2 years of follow-up Exclusion Criteria: * Prior prostate surgery (including cryosurgery) * Note: Patients who underwent TURP or greenlight PVP are eligible if it was \> 12 weeks prior to the anticipated start date of SBRT * Prior history of chronic prostatitis or urethral stricture * Currently active cancer(s) other than non-melanoma skin cancers. Patients are not considered to have currently active cancers if they have completed therapy and are considered by their physicians to be at \<5% risk of relapse within 2 years. * Life expectancy of \< 2 years

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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

  • The New York Proton Center

    New York, New York, 10035, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.