re withdrawn prior to the Month 1 blood draw. One patient did not achieve castration and was withdrawn on Day 85. All 5 non-eva luable patients who attained castration by Day 28, maintained castration at each timepoint up to and including the time of withdrawal.)
Jewett Stages Stage A - 2 2 5
Stage B - 19 38 43
Stage C 89 60 16 19
Stage D 31 36 34 44
Treatment 6 monthly injections 1 injection (4 patients) 1 injection (5 patients) 1 injection (5 patients)
2 injections, one every three months (113 patients) 2 injections, one every four months (85 patients) 2 injections, one every six months (106 patients)
Duration of therapy 6 months 6 months 8 months 12 months
Mean testosterone concentration (ng/dL) Baseline 361.3 367.1 385.5 367.7
Day 2 574.6 (Day 3) 588.0 610.0 588.6
Day 14 Below Baseline (Day 10) Below Baseline Below Baseline Below Baseline
Day 28 21.8 27.7 (Day 21) 17.2 16.7
Conclusion 6.1 10.1 12.4 12.6
Number of patients below castrate threshold
(≤ 50 ng/dL) Day 28 112 of 119 (94.1%) 115 of 116 (99%) 85 of 89 (96%) 108 of 109 (99.1%)
Day 35 - 116 (100%) - -
Day 42 119 (100%) - 89 (100%) -
Conclusion 117Two patients withdrew for reasons unrelated to drug. (100%) 111 (100%) 81 (99%) 102 (99%)
Table 4 Effect of ELIGARD® on Patient Serum PSA Values ELIGARD® 7.5 mg 22.5 mg 30 mg 45 mg
Mean PSA Reduction at Study Conclusion 94% 98% 86% 97%
Patients with Normal PSA at Study ConclusionAmong patients who presented with elevated levels at Baseline 94% 91% 93% 95%
Table 5 Secondary Efficacy Endpoints ELIGARD®
7.5 mg ELIGARD®
22.5 mg ELIGARD®
30 mg ELIGARD®
45 mg
Baseline WHO Status = 0WHO Status = 0 classified as "fully active." 88% 94% 90% 90%
WHO Status = 1WHO Status = 1 classified as "restricted in strenuous activity but ambulatory and able to carry out work of a light or sedentary nature." 11% 6% 10% 7%
WHO Status = 2WHO Status = 2 classified as "ambulatory but unable to carry out work activities." 3%
Mean Bone PainPain score scale: 1 (no pain) to 10 (worst pain possible). (range) 1.22 (1–9) 1.20 (1–9) 1.20 (1–7) 1.38 (1–7)
Mean Urinary Pain (range) 1.12 (1–5) 1.02 (1–2) 1.01 (1–2) 1.22 (1–8)
Mean Urinary Signs and Symptoms (range) Low 1.09 (1–4) Low Low
Number of Patients with Prostate Abnormalities 102 (85%) 96 (82%) 66 (73%) 89 (80%)
Month 6 Month 6 Month 8 Month 12
Follow-up WHO Status = 0 Unchanged 96% 87% 94%
WHO Status = 1 Unchanged 4% 12% 5%
WHO Status = 2 1% 1%
Mean Bone Pain (range) 1.26 (1–7) 1.22 (1–5) 1.19 (1–8) 1.31 (1–8)
Mean Urinary Pain (range) 1.07 (1–8) 1.10 (1–8) 1.00 (1–1) 1.07 (1–5)
Mean Urinary Signs and Symptoms (range) Modestly Decreased 1.18 (1–7) Modestly Decreased Modestly Decreased
Number of Patients with Prostate Abnormalities 77 (64%) 76 (65%) 54 (60%) 60 (58%)
ELIGARD® is indicated for the palliative treatment of advanced prostate cancer.
ELIGARD® 7.5 mg 22.5 mg 30 mg, like other LH-RH agonists, causes a transient increase in serum concentrations of testosterone during the first week of treatment. ELIGARD® 45 mg causes a transient increase in serum concentrations of testosterone during the first two weeks of treatme
