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Seven-fraction ultra-hypofractionation in intermediate-risk localised prostate cancer

Ten-year follow-up from the Scandinavian HYPO-RT-PC randomised trial reported non-inferior failure-free survival versus conventional fractionation, with similar long-term toxicity; no patients received androgen deprivation therapy.

  • Per Nilsson, PhD; Adalsteinn Gunnlaugsson, MD; Lars Beckman, MD; Anders Widmark, MD; Per Fransson, PhD; Morten Hoyer, MD; et al.

  • February 5, 2026

  • The Lancet Oncology
  • The Lancet Oncology, Volume 27, Issue 3, Pages 293–301
  • 10.1016/S1470-2045(25)00656-4

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Evidence before this study

We searched PubMed for studies published in English between Jan 1, 2019, and June 1, 2025, with “randomised trials” AND (”ultra-hypofractionated radiotherapy” OR “stereotactic body radiotherapy”) AND “prostate cancer” in the title or the abstract. Only one phase 3 trial was found: the PACE-B study. PACE-B reported 5-year outcomes, demonstrating that five-fraction stereotactic body radiotherapy was non-inferior to conventional or moderately hypofractionated radiotherapy in terms of biochemical or clinical failure and could be an effective treatment option for patients with low-risk to intermediate-risk localised prostate cancer. To our knowledge, no phase 3 trial has previously reported long-term follow-up beyond 5 years for ultra-hypofractionated regimens.

Added value of this study

This 10-year follow-up of the Scandinavian HYPO-RT-PC trial provides the longest reported randomised evidence to date on the efficacy and safety of ultra-hypofractionated radiotherapy for localised prostate cancer. The trial included a higher-risk patient population than PACE-B, and as in PACE-B, no patients received androgen deprivation therapy. Our results confirm the non-inferiority of ultra-hypofractionation compared with conventional fractionation in terms of failure-free survival, with similar long-term toxicity.

Implications of all the available evidence

These findings strengthen the clinical evidence supporting the seven-fraction ultra-hypofractionation schedule as a safe and effective treatment for patients with intermediate-risk prostate cancer. The results have important implications for clinical guidelines and practice, offering patients a more convenient and resource-efficient treatment option without compromising long-term outcomes.

Source: The Lancet Oncology

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