Data Source Type Arms Population Toxicity Results RTOG 85–31 [4 ] Prospective randomized trial WPRT + boost to 65–70 Gy (cT3, pT3, LN+) Total: 189 CR of CV 10-year OS benefit for all patients; OS benefit for Gleason 7–10 in subset analysis. RTOG 86–10 [5 ] Prospective randomized trial WPRT + Boost (66–70 Gy) ±2 mos. (nADT) and 2 mos. Total: 471 CR of CV Significant benefit in ↓ DM, ↑CSS, and ↑DFS, OS advantage for Gleason score <7. RTOG 92–02 [6 ] Prospective randomized trial WPRT + Boost to 65–70 Gy + 2 mos. nADT + 2 mos. cADT ± 2 year aADT Total: 1554 CR of CV death: Survival advantage for pts. with Gleason score 8–10. D’Amico et al. [7 , 8 ] Prospective randomized trial 45 Gy (prostate and seminal vesicles) + boost to 70 Gy ± 6 mos. ADT Total: 206 Age: OS advantage for pts. with hormonal manipulation with minimal or no comorbidities. RTOG 94–13 [9 ] Prospective randomized trial 70.2 Gy (50.4 to WP if on WP arms). 4 arms: Total: 1279
)
) WPRT + aADT (
)
) Acute radiation toxicity: Improved PFS in WPRT + nADT arm as compared to others. TROG 9601 [10 ] Prospective randomized trial 66 Gy + 0 versus 3 versus 6 mos. nADT (T2b-T4). Total: 818 Improvement in 5-year LF, bFFS, and DFS, freedom from salvage with 3 or 6 mos nADT. EORTC 22961 [11 ] Prospective randomized trial 70 Gy (50 Gy WPRT) + 6 mos. Total: 970 No difference in fatal cardiac events (3-4%). ↓ sexual function 3-year ADT improved overall mortality 19 versus 15.2%.Prostate cancer mortality: 4.7% versus 3.2%. RTOG 94–08 [12 ] Prospective randomized trial 66 Gy ± 2 mos. Total: 1989 Risk of acute, late GU, GI, and hemat. Short-term ADT before and during RT was associated with significantly decreased DSM and increased OS for IR pts. EORTC 22863 [13 ] Prospective randomized trial 70 Gy (50 Gy WPRT) ± 3 year goserelin starting on first day of RT. (T3-T4 or T1-T2 Gleason > 7) Total: 415 No difference in 10 year cardiac mortality (8–11%) OS and DFS benefit for patients on combined therapy arm. Crook et al. [14 ] Prospective randomized trial 3 or 8 mos. of flutamide or goserelin before 66 Gy RT Total: 378 — 5-year DFS improvement for high-risk patients in the 8 mos. arm. Nguyen et al. [28 ] Meta-analysis of 8 prospective randomized trials Nonmetastatic unfavourable risk PC pts ± ADT Total: 4141 ADT use is not associated with an increased risk of CVD ADT is associated with a lower risk of PCSM and all-cause mortality.
