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Updated: Jun 19, 2026

Stereotactic Radiosurgery for Gynecologic Cancer
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Single-Fraction Stereotactic Body Radiotherapy for Localized Prostate Cancer: A Nonrandomized Clinical Trial.

Thomas Zilli1,2,3,4, Ciro Franzese5,6, Matthias Guckenberger7

  • 1Radiation Oncology, Oncology Institute of Southern Switzerland, Ente Ospedaliero Cantonale, Bellinzona, Switzerland.

JAMA Oncology
|June 18, 2026
PubMed
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This summary is machine-generated.

Single-fraction stereotactic body radiotherapy (SBRT) for prostate cancer shows promising 3-year biochemical relapse-free survival. This approach demonstrates safety and efficacy, potentially offering a shorter treatment course for localized prostate cancer patients.

Area of Science:

  • Oncology
  • Radiation Oncology
  • Urologic Oncology

Background:

  • Stereotactic body radiotherapy (SBRT) is an established treatment for localized prostate cancer, typically delivered in 5 fractions.
  • Research is exploring reduced SBRT fractions, but the efficacy and tolerability of single-high-dose SBRT require further investigation.

Purpose of the Study:

  • To evaluate the safety and efficacy of single-fraction SBRT in men with localized prostate cancer.
  • To assess biochemical disease control and adverse events following a single 19-Gy prostate SBRT dose.

Main Methods:

  • A multicenter, single-arm, prospective phase 1/2 clinical trial involving men with low-to-intermediate risk localized prostate cancer.
  • Participants received a single 19-Gy fraction of prostate SBRT with urethra-sparing techniques and intrafraction motion control.

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  • Primary endpoint was 3-year biochemical relapse-free survival (bRFS); secondary endpoints included genitourinary (GU), gastrointestinal (GI), and sexual adverse events (AEs), and quality of life (QOL).

    • Main Results:

    • The 3-year bRFS was 92.9% (95% CI, 85.4%-100%), meeting the primary endpoint.
    • Grade 2 GU and GI AEs at 3 years were below 10% and 5%, respectively; one case of grade-3 proctitis occurred.
    • Erectile dysfunction (grade ≥2) increased from baseline (21.4%) to 38.4% at 3 years; GU and sexual quality of life scores showed minimal clinically important changes in a subset of patients.

    Conclusions:

    • Single-fraction 19-Gy urethra-sparing SBRT is a viable treatment option for localized prostate cancer, demonstrating acceptable toxicity and meeting its primary efficacy endpoint.
    • The observed 3-year bRFS of 92.9% supports the use of single-fraction SBRT, with low rates of severe GU and GI adverse events.
    • Longer follow-up is necessary to fully ascertain long-term disease control and the durability of treatment outcomes.