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Two quick zaps: new radiation approach aims to cut prostate cancer treatment time

NCT ID NCT05864196

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 early-phase trial is testing a new way to deliver radiation for low-to-intermediate risk prostate cancer. Instead of many sessions, it uses just two high-dose treatments, with an extra boost to the main tumor. The goal is to see if this approach is safe and feasible for about 80 men aged 18 and older.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 80 people

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

Started

Jul 2023

Expected to finish

Jun 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: * Patient age greater than or equal 18 * Localized adenocarcinoma of the prostate * Biopsy-proven diagnosis of prostate adenocarcinoma * Low to intermediate risk National Comprehensive Cancer Network (NCCN) disease * TX-T2c-8th addition staging * PSA\<20 ng/ml * Grade group 3 or less * Proper rectal space replacement required as determined by the treating radiation oncologist * Prostate size less than 60cc defined at time of simulation based on MRI * Patient ability to undergo MRI and documented dominant Prostate Imaging Reporting and Data System (PI-RADS) 3 or higher lesion \-- Exception is very low risk, low risk, or favorable intermediate risk with a low to intermediate decipher score in which case an SIB is not utilized * Androgen-deprivation therapy (ADT) is left to the discretion of the treating radiation oncologist * Agreement to use effective contraceptive methods such as condoms and spermicidal foam, intrauterine device, or for their partner to use prescription birth control pills * Ability to give informed consent Exclusion Criteria: * High risk disease * Pelvic lymph node involvement * Prophylactic lymph node irradiation requirement as determined by the treating radiation oncologist * Evidence of clinical or radiological extracapsular extension or seminal vesicle invasion * Prior radiation to the pelvis * Prior malignancies within the last 5 years * Inability to meet pre-specified 2 fraction DVH constraints * Prostate size \> 60cc as measures at treatment planning MRI * Active significant inflammatory bowel disease (IBD) or rheumatological disease * Prior prostate surgeries * Previous uro lift * Transurethral resection of the prostate (TURP) within 6 months of SBRT * "Reasonable" urinary, bowel, and erectile function as defined by the pre-treatment EPIC questionnaire (\>50 overall summary score for each domain) * Men of reproductive potential may not participate unless they agree to use an effective contraceptive method

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • NYCyberKnife at Perlmutter Cancer Center

    RECRUITING

    New York, New York, 10016, United States

  • NYU Langone Hospital - Long Island

    RECRUITING

    Mineola, New York, 11501, United States

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