TOPLINE:

Ultrahypofractionated radiotherapy demonstrated non-inferiority to conventional fractionation with higher 10-year failure-free survival with similar toxicity profiles in patients with intermediate- or high-risk localised prostate cancer.

METHODOLOGY:

• Researchers conducted an open-label, randomised, phase 3, non-inferiority trial across 12 centres (10 in Sweden and two in Denmark) and involved 1180 patients with intermediate- or high-risk localised prostate cancer between July 1, 2005, and November 4, 2015.
• Patients were randomly assigned in a 1:1 ratio to receive either ultrahypofractionated radiotherapy (n = 589; 42.7 Gy in seven fractions, 3 days per week for 2.5 weeks) or conventionally fractionated radiotherapy (n = 591; 78.0 Gy in 39 fractions, 5 days per week for 8 weeks).
• The primary endpoint was failure-free survival, defined as the time from randomisation to the first occurrence of biochemical failure, clinical progression, initiation of androgen deprivation therapy, or death from prostate cancer.
• Secondary endpoints included overall survival and physician-evaluated toxic effects.

TAKEAWAY:

• The estimated failure-free survival rate at 10 years was 65% in the conventional fractionation group and 72% in the ultrahypofractionation group (adjusted hazard ratio [HR], 0.84; 95% CI, 0.69-1.03).
• After a median follow-up duration of 10.6 years in the conventional fractionation group and 10.7 years in the ultrahypofractionation group, researchers observed 205 and 178 primary events, respectively, with a cumulative incidence of 31% and 26%, respectively, at 10 years, with non-prostate cancer death being a competing risk.
• Overall survival at 10 years was 79% in the conventional fractionation group and 81% in the ultrahypofractionation group (HR, 0.91; 95% CI, 0.75-1.11).
• The 10-year physician-recorded cumulative incidence of the first occurrence of late grade 2 or worse genitourinary toxic effects was 30% in the conventional fractionation group vs 28% in the ultrahypofractionation group (HR, 1.01; 95% CI, 0.81-1.25).
• The corresponding cumulative incidences of late grade 2 or worse gastrointestinal toxic effects were 14% in the conventional fractionation group and 14% in the ultrahypofractionation group at 10 years (HR, 0.94; 95% CI, 0.70-1.28).

IN PRACTICE:

"This 10-year update confirms the previous findings of the HYPO-RT-PC trial" and "these findings support the seven-fraction ultra-hypofractionated schedule as a safe, effective, and practical standard-of-care option for patients with intermediate-risk prostate cancer," the authors wrote.

SOURCE:

This study was led by Per Nilsson, PhD, and Adalsteinn Gunnlaugsson, MD, Department of Haematology, Oncology and Radiation Physics, Skåne University Hospital, Lund, Sweden. It was published online on February 05, 2026, in The Lancet Oncology.

LIMITATIONS:

The open-label design could have introduced observer bias, potentially influencing both physician and patient assessments of side effects. Most patients were treated with three-dimensional conformal radiotherapy, which is now considered outdated. Additionally, only 11% of patients had high-risk disease, making the findings most relevant to intermediate-risk prostate cancer.

DISCLOSURES:

This study was funded by the Nordic Cancer Union, the Swedish Cancer Society, the Swedish Research Council, the Swedish Prostate Cancer Association, and Cancerforskningsfonden i Norrland. The authors reported having no relevant conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.