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. 2019 Feb 6;15(3):108–120. doi: 10.1111/ajco.13108

Table 2.

Summary of results from important clinical trials that investigated radiotherapy as primary therapy with or without neoadjuvant or adjuvant ADT

Study (years) Level of evidencea Study type N Patient characteristics Treatment and duration Outcomes (95% CI)
1966–20067 1 Meta‐analysis 11 149 Localized or locally advanced PC with or without lymph node involvement (T1–4 N1, M0) Adjuvant ADT following RT versus RT alone

  • 5‐y OS: OR, 1.46 (1.17–1.83); P = 0.0009)

  • 10‐y OS: OR, 1.44 (1.13–1.84); P = 0.003

  • 5‐y DSS: OR, 2.10 (1.53–2.88); P = 0.00001

  • 5‐y DFS: OR, 2.53 (2.05–3.12); P < 0.00001
DFCI 9509631 (1995–2001) 2 Prospective, randomized 206 Localized (T1b‐T2b) but unfavorable‐risk PC RT plus 6 mo ADT (LHRHa + flutamide) versus RT alone

  • 8‐y OS: 74% (64–82%) versus 61% (49–71%); P = 0.01

  • Among men with no or minimal comorbidity, 8‐y OS: 90% (79–95%) versus 64% (49–75%); P < 0.001

  • Among men with moderate or severe comorbidity, 8‐y OS: 25% (9–44%) versus 54% (32–72%); P = 0.08
EORTC 2299132 (2001–2008) 2 Prospective, randomized 819 Localized (T1b‐T2aN0M0) or locally advanced (T2b‐T4) PC RT + concomitant/adjuvant ADT for 6 mo (goserelin) versus RT alone

  • 5‐y biochemical DFS: 82.6% (78.4–86.1%) versus 69.8% (64.9–74.2%); HR, 0.52 (0.41–0.66); P < 0.001

  • 5‐y clinical DFS: 88.7% (82.1–85.2%) versus 80.8% (76.5–84.3%); HR, 0.63 (0.48–0.84); P = 0.001
RTOG 94–0833 (1994–2001) 2 Prospective, randomized, phase 3 1979 T1b‐T2b PC with PSA ≤20 ng/mL 4 mo CAB beginning 2 mo before RT (46.8 Gy to pelvis and 19.8 Gy to prostate) versus RT alone

  • 10‐y OS: 62% versus 57%; HR, 1.17; P = 0.03

  • 10‐y DSM: 8% versus 4%; HR, 1.87; P = 0.001
RTOG 991034 (2000–2004) 2 Prospective, randomized 1579 Intermediate‐risk PC Neoadjuvant CAB (8 wk vs 28 wk) + 8 wk CAB during RT

  • 10‐y DSS: 95% (93.3–97.0) versus 96% (94.6–98.0); HR, 0.81; P = 0.45

  • 10‐y OS: 66% (62.0–69.9) versus 67% (63.0–70.8); HR, 0.95; P = 0.62)

  • 10‐y locoregional progression: 6% (4.3–8.0) versus 4% (2.5–5.7); HR, 0.65; P = 0.07

  • 10‐y distant metastasis: 6% (4.0–7.7) versus 6% (4.0–7.6; HR, 1.07; P = 0.80)

  • 10‐y PSA recurrence: 27% (23.1–29.8) versus 27% (23.4–30.3); HR, 0.97; P = 0.77)
TROG 96.0135 (1996–2000) 2 Prospective, randomized 818 T2b, T2c, T3, or T4, N0, M0 PC Neoadjuvant ADT (goserelin + flutamide, 6 mo vs 3 mo) + RT (66 Gy in 33 fractions over 6.5‐7 wk) versus RT alone

  • 10‐y PSA progression: 52.8% (46.5–58.7) versus 60.4% (54.2–66.1) versus 73.8% (68.1–78.7); P (6 mo vs RT) < 0.0001; P (3 mo vs RT) = 0.0009

  • 10‐y DSM: 11.4% (7.9–15.6) versus 18.9% (14.4–23.9) versus 22.0% (17.2–27.2); P = 0.0002; P = 0.394

  • 10‐y overall mortality: 29.2% (24.1–35.1) versus 36.7% (31.1–42.9) versus 42.5% (36.7–48.7); P = 0.0005; P = 0.198
DART01/05 GICOR36 (2005–2010) 2 Prospective, randomized, phase 3 355 Clinical stage T1c‐T3b N0M0 PC with intermediate‐ or high‐risk factors Short‐term ADT: Neoadjuvant and concomitant ADT for 4 mo +radiotherapy (3D conformal) versus long‐term ADT: the same treatment + adjuvant ADT for 24 mo

  • 5‐y BFS: 90% (87–92) versus 81% (78–85); HR, 1.88 (1.12–3.15); P = 0.01)

  • 5‐y OS: 95% (93–97) versus 86% (83–89); HR, 2.48 (1.31–4.68); P = 0.009

  • 5‐y MFS: 94% (92–96) versus 83% (80–86); HR, 2.31 (1.23–3.85); P = 0.01
EORTC 2286337 (1987–1995) 2 Prospective, randomized, phase 3 415 High‐risk T1–4 PC Long‐term ADT: 36 mo goserelin plus external RT (5 days/wk for 7 wk, total dose 50 Gy to whole pelvis plus additional 20 Gy to prostate and seminal vesicles) versus RT alone

  • 10‐y clinical DFS: 47.7% (39.0–56.0) versus 22.7% (16.3–29.7); HR, 0.42 (0.33–0.55); P < 0.0001

  • 10‐y OS: 58.1% (49.2–66.0) versus 39.8% (31.9–47.5); HR, 0.60 (0.45–0.80); P = 0.0004
RTOG 861038 (1987–1991) 2 Prospective, randomized, phase 3 456 Locally advanced (T2‐4) PC with or without lymph node involvement EBRT + neoadjuvant CAB (goserelin + flutamide) for 2 mo before and concurrent with EBRT versus EBRT alone

  • 10‐y OS: 42.6% (35.9–49.3) versus 33.8% (27.5–40.1); P = 0.12

  • 10‐y DFS: 11.2% (7.0–15.6) versus 3.4% (1.0–5.8); P < 0.0001

  • 10‐y DSM: 23.3% (17.6–29.1) versus 35.6% (29.2–42.0); P = 0.01

  • 10‐y distant metastases: 34.9% (28.5–41.3) versus 46.9% (40.3–53.5); P = 0.006

  • 10‐y biochemical failure: 65.1% (58.6–71.6) versus 80.0% (74.7–85.4); P < 0.0001
EORTC 2296139 (1997–2001) 2 Prospective, randomized 1113 Locally advanced (T1c–T2a–b, pN1–2, M0 or T2c–4, cN0–2, M0) PC EBRT (3D conformal, 50 Gy for first target volume, an additional 20 Gy for the second target volume, 5 d/wk for 7 wk) + ADT (LHRH analog) for 6 mo or 3 y 5‐y overall mortality: 19.0% versus 15.2%; HR, 1.42
Trials 23, 24, and 2540 (NR) 2 Three prospective, randomized trials 8113 Localized (T1–2 N0/Nx M0) or locally advanced (T3–4 and any N, or any T and N+; M0) PC Standard care plus either bicalutamide 150 mg daily or placebo

  • PFS: HR, 0.85 (0.79–0.91); P = 0.001; patients with locally advanced disease derived PFS benefit

  • OS: HR, 1.01 (0.94–1.09); P = 0.77; patients with locally advanced disease who received RT derived OS benefit: HR, 0.70 (0.51–0.97); P = 0.031
RTOG 85–3141 (1987–1992) 2 Prospective, randomized, phase 3 945 Locally advanced (T3 or regional lymphatic involvement) PC RT (1.8‐2.0 Gy) daily for 4‐5 times/wk for a total of 44–46 Gy plus additional 20‐25 Gy to prostate) plus adjuvant ADT (goserelin) until progression or RT alone followed by salvage ADT

  • 10‐y OS: 49% versus 39%; P = 0.002

  • 10‐y local failure: 23% versus 38%; P < 0.0001

  • 10‐y distant metastases: 24% versus 39%; P < 0.001

  • 10‐y DSM: 16% versus 22%; P = 0.0052
RTOG 92‐0242 (1992–1995) 2 Prospective, randomized 1554 Locally advanced (T2c‐T4, N0‐X) PC with no extra pelvic lymph node involvement and PSA < 150 ng/mL ADT (goserelin + flutamide) for 4 mo before and during RT (45 Gy to pelvic nodes and 65‐70 Gy to the prostate) with or without an additional 2 y goserelin after RT

  • 10‐y DFS: 22.5% versus 13.2%; P < 0.0001

  • 10‐y DSS: 88.7% versus 83.9%; P = 0.0042

  • 10‐y local progression: 12.3% versus 22.2%; P < 0.0001

  • 10‐y distant metastasis: 14.8% versus 22.8%; P < 0.0001

  • 10‐y BFS: 51.9% versus 68.1%; P ≤ 0.0001

  • 10‐y OS: 53.9% versus 51.6%; P = 0.36

  • 10‐y OS among patients with GS 8‐10: 45.1% versus 31.9%; P = 0.0061
SWOG‐JPR743 (1999–2005) 2 Prospective, randomized 1386 Rising PSA > 3 ng more than 12 mo after primary or salvage RT Intermittent salvage ADT (LHRHa + nonsteroidal antiandrogen in 8‐mo cycles versus continuous salvage ADT (LHRHa + nonsteroidal antiandrogen or orchiectomy)

  • Median OS: 8.8 y versus 9.1 y; HR, 1.02 (0.86–1.21); P value for noninferiority = 0.009

  • Median DSS: HR, 1.18; P = 0.24

  • Time to castration‐resistant disease: HR, 0.80; P = 0.02

ADT, androgen deprivation therapy; BFS, biochemical progression‐free survival; CAB, combined androgen blockade; DFS, disease‐free survival; DSM, disease‐specific mortality; DSS, disease‐specific survival; EBRT, external beam radiation therapy; GS, Gleason score; LHRH, luteinizing hormone‐releasing hormone; NR, not reported; OS, overall survival; PFS, progression‐free survival; PSA, prostate‐specific antigen; RP, radical prostatectomy; RT, radiotherapy.

a

Level of evidence determined by study design: 1, meta‐analysis or systematic review and 2, randomized controlled trial.