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Table 1 Important studies regarding the acute and late/cumulative toxicities for prostate SBRT

From: Magnetic resonance imaging-guided stereotactic body radiotherapy for prostate cancer (mirage): a phase iii randomized trial

Study Number of pts Risk group Arms Acute toxicities Late/cumulative toxicities
HYPO-RT-PC (2005–2015) 1200 Intermediate-risk: 89%
high-risk: 11%
UF-RT: 42.7 Gy in 7 fx (6.1 Gy/fx), delivered over 2.5 weeks
vs.
CF-RT: 79 Gy in 38 fx (2 Gy/fx)
Acute RTOG grade ≥ 2 GU toxicity: 28% vs. 23%;
acute RTOG grade ≥ 2 GI toxicity: 24% vs. 24%.
5-year grade ≥ 2 GU toxicity: 18% vs. 17%;
5-year grade ≥ 2 GI toxicity:
10% vs. 10%;
5-year grade ≥ 3 GU toxicity: 4.2% vs. 4.7%;
5-year grade ≥ 3 GI toxicity: 1.7% vs. 1.9%
PACE-B (2012–2018) 874 Low risk: 8%;
intermediate-risk: 92%
UF-RT: 36.25 Gy in 5 fx (7.25 Gy /fx delivered consecutively [20.7%] or over the span of ~ 2 weeks [79.3%])
vs.
CF-RT: 78 Gy in 39 fx (2 Gy/ fx)-31%
or
MF-RT: 62 Gy in 20 fx (3.1 Gy/fx)- 69%
Acute RTOG grade ≥ 2 GU toxicity exceeding baseline: 20.3% vs. 24.9%;
Acute RTOG grade ≥ 2 GI toxicity: 9.0% vs. 12.2%
N/A
Pooled SBRT consortium (12 single arm phase II studies between 2000 and 2012) 2142 low-risk: 55.3%;
favorable intermediate-risk: 32.3%;
unfavorable intermediate-risk: 12.4%
UF-RT: 38 Gy in 4 fx (9.5 Gy/ fx) or 40 Gy in 5 fx (8 Gy/fx) Acute grade ≥ 2 GU toxicity*: 9.6%;
acute grade ≥ 2 GI toxicity*: 3.4%.
Acute grade ≥ 3 GU toxicity*: 0.6%;
acute grade ≥ 3 GI toxicity*: 0.09%.
7-year cumulative incidence of late grade ≥ 3 GU toxicity: 2.4%; grade ≥ 3 GI toxicity: 0.4%.
  1. *Toxic event scoring derived per institutional or clinical trial protocols, which is a combination of CTCAE and RTOG defined events