Gustavo Viani: PACE-B supports SBRT as a noninferior option for prostate cancer

Gustavo Viani posted the following on LinkedIn:

“PACE-B supports SBRT as a noninferior option for localized prostate cancer with manageable toxicity profiles.

Objective:

• Determine if stereotactic body radiotherapy (SBRT) is noninferior to conventional or moderately hypofractionated radiotherapy in preventing biochemical or clinical failure in localized prostate cancer.

Methods:

• Phase 3, international, randomized controlled trial.
• 874 men with stage T1–T2 prostate cancer, Gleason score ≤3+4, and PSA ≤20 ng/mL, randomly assigned to:
• SBRT (36.25 Gy in 5 fractions over 1–2 weeks)
• Control (78 Gy in 39 fractions over 7.5 weeks or 62 Gy in 20 fractions over 4 weeks)
• No androgen-deprivation therapy allowed.
• Endpoint: Freedom from biochemical or clinical failure (noninferiority threshold: HR 1.45)

Results:

• 5-year freedom from biochemical or clinical failure: 95.8% (SBRT) vs. 94.6% (control).
• SBRT demonstrated noninferiority (HR 0.73; P=0.004 for noninferiority).
• Cumulative incidence of late G 2+ genitourinary toxicity: 26.9% (SBRT) vs. 18.3% (control) (P<0.001).”

Phase 3 Trial of Stereotactic Body Radiotherapy in Localized Prostate Cancer

Authors: Nicholas van As, M.D., Clare Griffin, M.Sc., Alison Tree, M.D., Jaymini Patel, Ph.D., Peter Ostler, F.R.C.R., Hans van der Voet, M.D., Andrew Loblaw, M.D., William Chu, M.D., Daniel Ford, F.R.C.R., Shaun Tolan, M.B., B.Ch., Suneil Jain, Ph.D., Philip Camilleri, F.R.C.R., Kiran Kancherla, F.R.C.R., John Frew, F.R.C.R., Andrew Chan, F.R.C.R., Olivia Naismith, M.Sc., John Armstrong, F.F.R.R.C.S.I., John Staffurth, M.D., Alexander Martin, M.D., Ian Dayes, M.D., Paula Wells, Ph.D., Derek Price, Emily Williamson, M.Sc., Julia Pugh, C.I.M.Dip., Georgina Manning, B.A., Stephanie Brown, Ph.D., Stephanie Burnett, B.Sc., and Emma Hall, Ph.D.

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Gustavo Viani, MD is an Associate Professor in the Department of Medical Imaging, Hematology, and Oncology at Hospital das Clínicas, Faculty of Medicine of Ribeirão Preto, University of São Paulo (FMRP-USP). Dr. Viani’s research focuses on radiation oncology, with expertise in brachytherapy, stereotactic radiosurgery, dose fractionation, radiation tolerance, and overall oncology practices.