Table 1: Prospective trials of hypofractionated external-beam radiotherapy (>5 fractions).

AuthorNo. of patientsType of studyPatient characteristics NCCN risk groupHYPO FX total dose (Gy)/fractional dose (Gy)STD FX total dose (Gy)/fractional dose (Gy)Median follow up (months)PSA controlLate GU toxicityLate GI toxicity
HypoSTDHypoSTDToxicityHypoSTDToxicity

Lukka et al. [13]936Phase IIILow-Intermediate risk52.5/2.6366/26858%62%*NSNS

Pollack et al. [14, 15]303Phase IIIIntermediate
High risk
70.2 /2.776/2>60 months18.3%8.3%≥Gr-26.8%5%≥Gr-2
P = 0.028NS

Yeoh et al. [16]217Phase IIILow risk55 /2.7564/29053%34%*NSNS
P < 0.05

Coote et al. [17]60Phase I/IIT2-3 N0M0
and
GS ≥7
or
PSA 20–50
57–60/32473%*4%
4%

Gr-2
Gr-3
9.5%
0%

Gr-2
Gr-3

Martin et al. [18]92Phase IIT1c-2 CNXM0
Low-high
risk
60/338 97%* at 14 months3%
0%

Gr-2
Gr-3
4%
0%

Gr-2
Gr-3

Dearnaley et al. [19]153Phase IIIT1B-3A
N0M0
GS 6–8
PSA < 50
Low-high risk
57–60/374/250.54.82–9%
0.7–4.2%
3.5%
1.4%
Gr- 2
Gr-3
4.8–6.9%
0.7%
7.6%
0%
Gr-2
Gr-3
NSNS

Arcangeli et al. [20]168Phase IIIHigh Risk62/3.180/23287%70%*NSNS
P = 0.035

Norkus et al. [21, 22]91Phase IIIT1-3 N0M0
GS ≤ 7
PSA ≤10
57/3–4.574/2NS during 1st 12 months

Soete et al. [23]36Phase IIT1-T3 N0M056/3.52

Ritter et al. [24]307Phase I/IILow-Intermediate risk64.7/2.94
58.08/3.63
51.6/4.3
16–42 95%* at 5 years3%Gr-28.8%Gr-2

11%Gr 24%Gr- 2
Menkarios et al. [25]81Phase I/IILow risk45/53397%*0%Gr-30%Gr- 3
4%Gr-40%Gr-4
at 37 months at 37 months

No.: Number, HYPO FX: hypofractionation, STD FX: standard, Gy: Gray, FX: fractionation, *: by Phoenix definition, NS: not significantly different, GS: Gleason’s score.