Stereotactic Ablative Radiation Therapy for Prostate Cancer

Running, not enrolling · Not applicable

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT05668351

Run by

Medical University of South Carolina

People needed

42

Starts

2023-05-12

Expected to finish

2028-01-15

Last updated by the study team

2026-02-19

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Female patients (due to lack of prostate gland)
• Concurrent use of testosterone supplementation
• Known homozygous for ATM pathogenic mutation
• Prior pelvic RT
• Treatment with another investigational drug for prostate cancer
• Pre-existing conditions or overall health status which disqualifies the patient from curative-intent RT
• 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
• Patients with distant metastases from prostate cancer
• Patients with lymph node involvement by prostate cancer
• 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
• Unwilling or unable to provide informed consent

Where it is running

• Medical University of South Carolina Hollings Cancer Center — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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