Table 1.
Prospective trials of hypofractionated external-beam radiotherapy (>5 fractions).
| Author | No. of patients | Type of study | Patient characteristics NCCN risk group | HYPO FX total dose (Gy)/fractional dose (Gy) | STD FX total dose (Gy)/fractional dose (Gy) | Median follow up (months) | PSA control | Late GU toxicity | Late GI toxicity | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hypo | STD | Hypo | STD | Toxicity | Hypo | STD | Toxicity | |||||||
| Lukka et al. [13] | 936 | Phase III | Low-Intermediate risk | 52.5/2.63 | 66/2 | 68 | 58% | 62%* | NS | NS | ||||
|
| ||||||||||||||
| Pollack et al. [14, 15] | 303 | Phase III | Intermediate High risk |
70.2 /2.7 | 76/2 | >60 months | 18.3% | 8.3% | ≥Gr-2 | 6.8% | 5% | ≥Gr-2 | ||
| P = 0.028 | NS | |||||||||||||
|
| ||||||||||||||
| Yeoh et al. [16] | 217 | Phase III | Low risk | 55 /2.75 | 64/2 | 90 | 53% | 34%* | NS | NS | ||||
| P < 0.05 | ||||||||||||||
|
| ||||||||||||||
| Coote et al. [17] | 60 | Phase I/II | T2-3 N0M0 and GS ≥7 or PSA 20–50 |
57–60/3 | — | 24 | 73%* | — | 4% 4% |
— — |
Gr-2 Gr-3 |
9.5% 0% |
— — |
Gr-2 Gr-3 |
|
| ||||||||||||||
| Martin et al. [18] | 92 | Phase II | T1c-2 CNXM0 Low-high risk |
60/3 | — | 38 | 97%* at 14 months | 3% 0% |
— — |
Gr-2 Gr-3 |
4% 0% |
— — |
Gr-2 Gr-3 |
|
|
| ||||||||||||||
| Dearnaley et al. [19] | 153 | Phase III | T1B-3A N0M0 GS 6–8 PSA < 50 Low-high risk |
57–60/3 | 74/2 | 50.5 | — | 4.82–9% 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 |
|
| NS | NS | |||||||||||||
|
| ||||||||||||||
| Arcangeli et al. [20] | 168 | Phase III | High Risk | 62/3.1 | 80/2 | 32 | 87% | 70%* | NS | NS | ||||
| P = 0.035 | ||||||||||||||
|
| ||||||||||||||
| Norkus et al. [21, 22] | 91 | Phase III | T1-3 N0M0 GS ≤ 7 PSA ≤10 |
57/3–4.5 | 74/2 | — | NS during 1st 12 months | — | — | |||||
|
| ||||||||||||||
| Soete et al. [23] | 36 | Phase II | T1-T3 N0M0 | 56/3.5 | — | 2 | — | — | — | |||||
|
| ||||||||||||||
| Ritter et al. [24] | 307 | Phase I/II | Low-Intermediate risk | 64.7/2.94 58.08/3.63 51.6/4.3 |
— | 16–42 | 95%* at 5 years | 3% | — | Gr-2 | 8.8% | — | Gr-2 | |
|
| ||||||||||||||
| 11% | — | Gr 2 | 4% | — | Gr- 2 | |||||||||
| Menkarios et al. [25] | 81 | Phase I/II | Low risk | 45/5 | — | 33 | 97%* | 0% | — | Gr-3 | 0% | — | Gr- 3 | |
| 4% | — | Gr-4 | 0% | — | 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.