Table 5.
Trial | Sample Size | Inclusion Criteria | RT Technique | Fractionation | Outcomes | Median Follow-Up | Results |
---|---|---|---|---|---|---|---|
HYPO-RT-PC [83,84] | 1200 | Intermediate-to-high-risk prostate cancer: T1c–T3a with 1–2 factors: stage T3a, Gleason ≥7, PSA 10–20 ng/mL; no lymph node/metastases involvement | 3D/IMRT/VMAT Image-guided |
42.7 Gy/7 fx 78 Gy/39 fx |
FFS and QOL | 4 years | 5 yr FFS 84% in both arms Urinary bother: conventional 33% (43/132) vs. ultra-hypofractionation 28% (33/120), p = 0.38. Bowel bother: conventional 33% (43/129) vs. ultra-hypofractionation 28% (34/123), p = 0.33. Sexual bother: conventional 60% (75/126) vs. ultra-hypofractionation 50% (59/117), p = 0.15. Global health/QOL: conventional 42% (56/134) vs. ultra-hypofractionation 37% (46/125), p = 0.41. |
PACE-B [85,86] | 874 | Low- and intermediate-risk (91% were intermediate-risk, 9% low) |
78 Gy/39 fx or 62 Gy/20 fx 36.25 Gy to PTV, 40 Gy to CTV |
BCF | 6.1 years | 5-year BCF event-free rate: CRT 94.6% (91.9–96.4%) vs. SBRT 95.7% (93.2–97.3%). SBRT non-inferior to CRT: HR = 0.74 (0.47–1.17), p-value = 0.007. Absolute difference at 5 years: 1.36% (90% CI: 0.87–2.80%). Toxicity at 5 years: RTOG G2+ GU: CRT 3.2% (11/348) vs. SBRT 5.5% (20/363), p = 0.14. RTOG G2+ GI: both groups had 1 case (CRT 1/348, SBRT 1/363), p = 0.99. |
Legend: QOL: quality of life; HR: hazard ratio; fx: fractions; CRT: conventional radiotherapy. GI: gastrointestinal; GU: genitourinary.