Author

Study period

N

Main eligibility

ADT

RT

Key outcomes

Bolla

(EORTC 22863)

[11]

1987-1995

415

T1-2 high Gleason grade or T3-4 any Gleason grade, all clinically N0.

3 yrs, LHRH starting on commencing RT

Prostate and pelvis

70 Gy to the prostate and SV, 50 Gy to the pelvis

10-year OS 58.1% vs 39.8% p = 0.0004 in favour of RT + ADT

Roach

(RTOG 86-10)

[17]

1987-1991

456

bulky (5 × 5 cm) tumors (T2-4) with or without pelvic lymph node involvement

33% node positive below the common iliac chain

4 months ADT starting 2 months before RT

Prostate and pelvis

65 - 70 Gy to the prostate and SV, 44 - 46 Gy to the pelvis

Ten-year OS (43% v 34%) and median survival times (8.7 v 7.3 years); (p = .12) favouring ADT and EBRT, respectively.

10-year DFS (11% v 3%; p < 0.0001), and BF (65% v 80%; p < 0.0001) with the addition of ADT, but no differences were observed in the risk of fatal cardiac events.

Lawton

(RTOG 85-31)

[34] [35]

1987-1992

945

(pN+) or gross extension of the palpable primary tumor beyond the prostate (clinical Stage T3)

Continuous until disease progression starting last week of radiotherapy (arm 1), or at time of relapse (arm 2)

Prostate and pelvis

64 - 70 Gy to the prostate and SV, 44 - 46 Gy to the pelvis

At 10 years, the absolute survival rate for RT + ADT arm vsADT at relapse arm 49% vs. 39%, p = 0.002).

10-year rates for the incidence of distant metastases and disease-specific mortality was 24% vs. 39% (p < 0.001) and 16% vs. 22% (p = 0.0052), respectively, both in favor of the RT + ADT arm.

Mason

[13]

1995-2005

1205

T3-4, N0/Nx, M0 or T1-2 disease with either PSA > 40 μg/L or PSA of 20 to 40 μg/L plus Gleason score of 8 to 10.

Continuous

Prostate and pelvis

65 - 69 Gy to the prostate and SV, 45 Gy to pelvic nodes

At 8 years, the combined RT and ADTarm resulted in reduced disease-specific mortality (absolute difference = 20%; HR = 0.46), and overall mortality (absolute difference = 6%; HR = 0.70)

Roach

(RTOG 94-13)

[19]

1995-1999

1275

Risk of lymph node involvement> 15%, node negative

median PSA-22.6 ng/mL,

67% of patients had T2c to T4 disease,

72% had a GS of 7 to 10

2X2 factorial

4 arms

NHT- PORT

NHT-WPRT

AHT-PORT

AHT-WPRT

NHT-4 months

starting 2 months before RT

AHT-4 months from completion of RT.

PORT (Prostate)

70.2 Gy

WPRT

(Prostate and pelvis)

70.2 Gy prostate

50.4 Gy

pelvis

Initial results demonstrated a significant improvement in 4-year PFS, favouring WPRT (54% vs. 47%; p = 0.022); WPRT with NCHT had the highest 4-year PFS (60%).

Updated results with median follow up of 6.6 years, no statistically significant differences were found in PFS or OS between NHT vs. AHT and WPRT vs. PO-RT

Widmark

[12]

1996-2000

875

Node negative, M0 PSA <70. Any T3,or high grade T1b-T2

Participants with a PSA of >11 ng/mL had a pelvic lymph node dissection

Continuous

3 months initial MAB, then anti androgen therapy until death

Prostate

50 Gy-prostate and SV, + 20 Gy boost to prostate

10 yrprostate-cancer-specific mortality 23.9% in the ADT alone group vs 11.9% in the ADT plus radiotherapy group (difference 12.0%, 95% CI 4.9% - 19.1%.

Denham

(TROG 96-01)

[21]

1996-2000

802

T2b, T2c, T3, and T4 N0 M0

(>80% high risk)

0, 3 and 6 months ADT

with 2 and 5 months NHT for 3 and 6 months randomisation

Prostate

(66 Gy)

At 10 years- both 3 and 6 months of hormone therapy significantly reduced local progression (HR = 0.49; p = 0.0005 and HR = 0.45; p = 0.0001, respectively), and improved event-free survival HR = 0.63; p < 0.0001 and HR = 0.51; p < 0.0001, respectively.