Table 1 Hypofractionated primary radiotherapy for prostate cancer

Rome, Italy [14]

168 pat.

Arm I: 80Gy/2Gy/40 fractions; ArmII: 62Gy/3.1Gy/20 fractions, 4x/week.

82.1Gy

74.2Gy

70 months

Arm I: 40% ≥ II° GI, Arm II: 47% ≥ II° GI.

Arm I: 16% ≥ II° GI, Arm II: 11% ≥ II° GI.

Arm I: 21% = II° GI, Arm II: 35% = II° GI.

Arm I: 17% ≥ II° GI, Arm II: 14% ≥ II° GI.

Hypofraction-RT is not inferior to conventional RT, potentially even better for high-risk pat. (iPSA > 20 ng/ml, GS > 7, cT > 2c).

11 UK centres [15]

Arm I: 153 pat. 74Gy; Arm II 153 pat. 60Gy and 151 pat. 57Gy.

Arm I: 74Gy/2Gy/37 fractions; Arm II: 57-60Gy/3Gy/19-20 fractions

73.8/77.6Gy

68.4/72Gy

50.5 months

-

3 pat. (2 · 2%) in 74Gy group, 3 (2 · 2%) in 60Gy group, and 0 in 57Gy group ≥ II° GU.

-

6 pat. (4 · 3%) in Arm I ≥ II° GI RTOG, 5 pat. (3 · 6%) in Arm II, 2 (1 · 4%) in 57Gy group.

-

Fox Chase, Philadelphia [16]

307 pat. (ASTRO Update 2011)

Arm I: 76Gy/2Gy/28 fractions; Arm II: 70.2Gy/2.7Gy/26 fractions

84.7Gy

80Gy

5 years

Arm I: 54% > II°; 2% > III°; Arm II: 40% > II°; 8% > III°.

Arm I: 8.3%; Arm II: 18.3% at 5 years.

Arm I: 8% > II° GI; Arm II: 18% > II° GI.

-

biochemical recurrence 21.5% vs. 21.9% at 5 years

MDACC [17]

101 pat. in CIMRT, 102 pat. in HIMRT arm. For all pat. 28% low-risk, 71% intermed.-risk, 1% high-risk

CIMRT arm: 75.6 Gy/1.8Gy/42 fractions; HIMRT arm: 72Gy/2.4Gy/30 fractions

85,5Gy

81Gy

6 years

-

At 5 years, CIMRT: 15% I°, 14% II°, 1% III°; HIMRT: 10% I°, 15% II°, 0% III°.

-

At 5 years, CIMRT: 17% I°, 4% II°, 1% III°;HIMRT: 26% I°, 9% II°, 2% III°.

-

Ontario, Canada [11]

Arm I: 470, Arm II: 436 pat.

Arm I: 66Gy/2Gy/33 fractions; Arm II: 52.5Gy/2.63Gy/20 fractions

62.2Gy

59.1Gy

5.7 years

Arm I: 7% ≥ III° GU, Arm II: 11.4% ≥ III° GU.

Arm I: 1.9% ≥ III° GU, Arm II: 1.9% ≥ III° GU.

Arm I: 2.6% ≥ III° GI, Arm II: 4.1% ≥ III° GI.

Arm I: 1.3% ≥ III° GI, Arm II: 1.3% ≥ III° GI.

at 5 years, BCF in Arm I 53%, in Arm II 60%.

Adelaide, Australia [13]

Arm I: 108 pat.; Arm II: 109 pat.

Arm I: 64Gy/2Gy/32 fractions; Arm II: 55Gy/2.75Gy/20 fractions

67.1Gy

63.25Gy

90 months

-

no signif. diff. between 2 groups at 5 years

-

no signif. diff. between 2 groups

biochemical relapse-free survival at 90 months 53% in hypofraction Arm vs. 34% in control Arm.

Vilnius, Lithuania [50]

91 pat. low- and intermed.-risk

Arm I: 74Gy/2Gy/37 fractions; Arm II: 57Gy = 13×3Gy + 4×4.5Gy

84.9Gy

73.8Gy

3 months

Arm I: 21 (47.7%) and Arm II: 9 (19.1%) = II° GU.

-

Arm I: 10 (22.7%) and Arm II: 8 (17%) = II° GI.

-

-

Milan, Italy [51]

337 all cT1-2. 40.9% low-risk; 43.3% intermed-risk; 14.2% high-risk.

70.2Gy/2.7Gy/26 frations

84.7Gy

80Gy

19 months

35% ≥ II° GU, 6.2% ≥ III° GU.

10.4% ≥ II° GU, 1.6% ≥ III° GU.

11.3% ≥ II° GI, 1.2% ≥ III° GI.

7.5% ≥ II° GI, 1.3% ≥ III° GI.

-

Cleveland Ohio [18]

770 pat, 34% low-risk, 28% intermed.-risk, 38% high-risk .

70Gy/2.5Gy/28 fractions, but mean target dose was 75.3Gy at 2.7Gy.

80.3Gy, 90.8Gy (mean target dose)

77Gy

45 months

48% I°, 18% II°, 1% III° RTOG GU.

4.3% I°, 5.1% II°, 0.1%(1 pat.) III° RTOG GU.

40% I°, 9% II° RTOG GI.

5.9% I°, 3.1% II°, 1.3% III°, 0.1%(1 pat.) IV° RTOG GI.

nadia + 2 ng/ml bRFS at 5 years 83%, and 94%, 83%, 72%.