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New radiation method aims to cut side effects in prostate cancer treatment

NCT ID NCT05668351

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests a new way to deliver high-dose radiation (SABR) for low- and intermediate-risk prostate cancer. The technique, called SUPR-SABR, is designed to avoid the urethra, rectum, and pudendal artery to reduce urinary and bowel side effects. About 42 men will receive five radiation sessions over 1-2 weeks, and researchers will track their quality of life and side effects for two years.

What this could mean

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

Active substance
Stereotactic ablative body radiotherapy (SABR) with urethra, pudendal artery, and rectum sparing
What this could lead to
If successful, this approach could reduce urinary and bowel side effects from radiation therapy for prostate cancer, making treatment more tolerable.
What could go wrong
This is a small, early-phase trial with only 42 participants and no comparison group. It is not yet known if the new technique controls cancer as well as standard SABR.

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

42 people

The number who actually took part.

Started

May 2023

Expected to finish

Jan 2028

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: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male patients aged 18 years and older 4. In good general health as evidenced by medical history to be a candidate for curative-intent prostate cancer treatment 5. Ability to receive pelvic radiotherapy and be willing to adhere to the SUPR-SABR regimen 6. Previously untreated prostate cancer (with cytotoxic chemotherapy, surgical or radiation therapy) 7. Localized adenocarcinoma of the prostate with the following features: 1. cT1-T2c 2. PSA\<20 * Patients receiving a 5-alpha reductase inhibitor must have a PSA \<10 3. Grade Group 1-3 8. Patient willing and able to complete the EPIC questionnaire at time of registration and 1-, 12-, and 24- months post treatment 9. Prostate volume \<120 cc 10. History and physical including a digital rectal exam 90 days prior to registration 11. ECOG performance status 0-2 12. Be eligible and willing to undergo MRI prostate and pelvis as a component of RT planning 13. Bone and soft tissue imaging as clinically indicated (for unfavorable intermediate risk or symptomatic patients only) within 120 days prior to registration 14. IPSS score ≤20 at time of initial history and physical with treating radiation oncologist Exclusion Criteria: 1. Female patients (due to lack of prostate gland) 2. Concurrent use of testosterone supplementation 3. Known homozygous for ATM pathogenic mutation 4. Prior pelvic RT 5. Treatment with another investigational drug for prostate cancer 6. Pre-existing conditions or overall health status which disqualifies the patient from curative-intent RT 7. Prior or concurrent invasive pelvic malignancy (except non-melanomatous skin cancer) or lymphomatous or hematogenous malignancy, unless disease free for a minimum of 5 years 8. Patients with distant metastases from prostate cancer 9. Patients with lymph node involvement by prostate cancer 10. Prior prostatectomy, cryotherapy, high-intensity focused ultrasound, pelvic irradiation overlapping with fields needed for prostate cancer treatment, prostate brachytherapy, or previous cytotoxic chemotherapy for prostate cancer 11. Unwilling or unable to provide informed consent

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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.

Contacts and locations

Locations

  • Medical University of South Carolina Hollings Cancer Center

    Charleston, South Carolina, 29425, United States

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