Table 1.
Published phase II and III trials on degarelix and prostate cancer: Efficacy
| Author | Patients | Study design | Results |
|---|---|---|---|
| Gittelman20 | N = 127 |
Phase II Efficacy and safety of degarelix with a starting dose of 200 mg followed by monthly maintenance doses of 60 mg or 80 mg for one year. |
Testosterone suppression: 88% after one month, 93% and 98% (60 mg and 80 mg) after one year. PSA response: Median reduction 96% after one year |
| van Poppel21 | N = 187 |
Phase II Efficacy and safety of degarelix with a 200 mg or 240 mg starting dose followed by monthly maintenance doses of 80 mg, 120 mg, or 160 mg for one year. |
Testosterone suppression: 86% (200 mg) vs 95% (240 mg) after one month, 92% (80 mg), 96% (120 mg), 100% (160 mg) after one year. PSA response: Median reduction 97%–98% after one year |
| Klotz14 | N = 610 |
Phase III Efficacy and safety of degarelix with a starting dose of 240 mg followed by monthly maintenance dose of 80 mg or 160 mg vs leuprolide 7.5 mg monthly. |
Testosterone suppression: 97.2%, 98.3% in patients treated with degarelix (240/80 mg, 240/160 mg) and 96.4% in patients treated with leuprolide after one year. PSA response: PSA decline from baseline was significant faster in the degarelix groups than with leuprolide, PSA values not given in publication. |
Abbreviation: PSA, prostate-specific antigen.