NCT05668351Active, not recruiting
Stereotactic Ablative Radiation Therapy for Prostate Cancer
Phase II Trial of Sparing the Urethra, Pudendal Artery and Rectum During Stereotactic Ablative Body Radiotherapy (SUPR-SABR) for Low and Intermediate Risk Prostate Cancer
Source: ClinicalTrials.gov · Last updated 19 Feb 2026
Brief summary (registry, in English)
This single arm trial will investigate a novel way to plan and deliver SABR for prostate cancer. Prostate-directed SABR will be high-dose SABR (40 Gy in 5 fractions) with central sparing of the urethra and peripheral sparing of the rectum and pudendal arteries (SUPR-SABR). This study tests the hypothesis that genitourinary (GU) and gastrointestinal (GI) toxicity rates following SUPR-SABR are comparable to (or possibly lower than) historical GU and GI toxicity rates following standard SABR (stSABR) with 36.25 Gy in the treatment of low- and intermediate-risk prostate cancer.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 42 (actual)
- First submitted
- 6 Dec 2022
- Start date
- 12 May 2023
- Primary completion date
- 15 Jan 2028
- Lead sponsor
- Medical University of South Carolina
- Diseases
- Prostate cancer
- NCT number
- NCT05668351
What you commit to
- Study type: Interventional
- Participants enrolled: 42
- From 12 May 2023 to the primary completion date, 15 Jan 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent use of testosterone supplementation
- Prior pelvic RT
- Treatment with another investigational drug for prostate cancer
- 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
- 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
Other illness
- Pre-existing conditions or overall health status which disqualifies the patient from curative-intent RT
- Patients with distant metastases from prostate cancer
- Patients with lymph node involvement by prostate cancer
Other
- Female patients (due to lack of prostate gland)
- Known homozygous for ATM pathogenic mutation
- Unwilling or unable to provide informed consent
Who the study is looking for
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male patients aged 18 years and older
- In good general health as evidenced by medical history to be a candidate for curative-intent prostate cancer treatment
- Ability to receive pelvic radiotherapy and be willing to adhere to the SUPR-SABR regimen
- Previously untreated prostate cancer (with cytotoxic chemotherapy, surgical or radiation therapy)
- Localized adenocarcinoma of the prostate with the following features:
- cT1-T2c
- PSA\<20
- Patients receiving a 5-alpha reductase inhibitor must have a PSA \<10
- Grade Group 1-3
- Patient willing and able to complete the EPIC questionnaire at time of registration and 1-, 12-, and 24- months post treatment
- Prostate volume \<120 cc
- History and physical including a digital rectal exam 90 days prior to registration
- ECOG performance status 0-2
- Be eligible and willing to undergo MRI prostate and pelvis as a component of RT planning
- Bone and soft tissue imaging as clinically indicated (for unfavorable intermediate risk or symptomatic patients only) within 120 days prior to registration
- IPSS score ≤20 at time of initial history and physical with treating radiation oncologist
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of South Carolina - Hollings Cancer Center Coordinator of this site? Confirm its status | Charleston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.