New radiation method aims to cut side effects in prostate cancer treatment
NCT ID NCT05668351
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
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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
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42 people
The number who actually took part.
- Started
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May 2023
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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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 Hide 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
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Medical University of South Carolina Hollings Cancer Center
Charleston, South Carolina, 29425, United States
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Other studies related to the condition(s) this trial covers.
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- A scanner in the operating room could show surgeons exactly where prostate cancer remains