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

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%.