Table 3.
Study characteristics (abarelix)
| 149-98-02 | 149-98-03 | 149-99-03 | ABACS 1 | 149-97-04 | Garnick 2011 | |
|---|---|---|---|---|---|---|
| Design (duration of study) | Randomised controlled trial (169 days) | Randomised controlled trial (169 days) | Randomised controlled trial (169 days) | Randomised controlled trial (364 days) | Prospective non-randomised controlled clinical trial (27 days) | Non-randomised prospective cross-over study (84/56 days) |
| Geographical region | Multicentre/USA | Multicentre/USA | Multicentre/USA | Multicentre/Europe | Multicentre/USA | Multicentre/USA |
| Patients included | 271 | 255 | 584 | 177 | 242 | 176 |
| Non-metastatic disease | 165/269 (61%) | 145/251 (58%) | NR | NR | NR | 143/176 (80%) |
| Metastatic disease | 104/269 (39%) | 106/251 (42%) | 30/582 (5%) | NR | NR | 12/176 (8%) |
| Non-classified disease | – | – | 552/582 (95%) | – | – | 21/176 (12%) |
| Gleason-Score 2–6 | 121/269 (45%) | 144/251 (57%) | NR | NR | NR | 97/176 (55%) |
| Gleason-Score 7 | 81/269 (30%) | 61/251 (24%) | NR | NR | NR | 73/176 (41%) |
| Gleason-Score 8–10 | 56/269 (21%) | 34/251 (14%) | NR | NR | NR | 6/176 (3%) |
| Gleason-Score non-classified | 11/269 (4%) | 12/251 (5%) | – | – | – | – |
| Intervention (N) | Abarelix 100 mg* (n=180) | Abarelix 100 mg* (n=170) | Abarelix 100 mg* (n=390) | Abarelix 100 mg* (n=87) | Abarelix 100 mg* (n=209) | Abarelix 100 mg* (n=176) |
| Control (N) | Leuprolide 7.5 mg monthly (n=91) | Leuprolide 7.5 mg monthly + bicalutamide 50 mg daily (n=85) | Leuprolide 7.5 mg monthly (n=194) | Goserelin 3.6 mg monthly + bicalutamide 50 mg daily (n=90) | Leuprolide or Goserelin with(out) antiandrogen (n=33) | Leuprolide 7.5 mg monthly or goserelin 3.6 mg monthly (n=176) |
| Outcomes | Achievement of castration (day <8, <29, <365); measurement of testosterone levels/endocrine efficacy/PSA levels, adverse events | Achievement of castration (day <8, <29, <365); measurement of testosterone levels/endocrine efficacy/PSA levels, adverse events | Achievement of castration (day <8, <365); adverse events, discontinuation of treatment, measurement of PSA levels | Achievement of castration (day <8, <365), measurement of testosterone levels, adverse events | Achievement of castration (day <8, <365), measurement of testosterone levels/endocrine efficacy/PSA levels, adverse events | Achievement of castration (day <8, <365), measurement of testosterone levels, adverse events |
*Abarelix depot 100 mg intramuscular given on day 0, day 15 and every 4 weeks, thereafter.
NR, not reported; PSA, prostate-specific antigen.