A phase 3, multicenter, open-label, randomized study of abarelix versus leuprolide acetate in men with prostate cancer - 03/09/11

Doi : 10.1016/S0090-4295(01)01342-5

David McLeod ^⁎,^a,^{^{3
D. McLeod, N. Zinner, K. Tomera, and D. Gleason are study investigators funded by Praecis Pharmaceuticals, Inc. N. Zinner is a paid consultant to Praecis Pharmaceuticals, Inc. M. Campion and M. Garnick hold stock in Praecis Pharmaceuticals, Inc. N. Fotheringham and M. Garnick hold stock in Amgen, Inc., which had a licensing agreement with Praecis Pharmaceuticals, Inc. for the distribution of the mentioned product.}}, Norman Zinner ^b,^{^{3
D. McLeod, N. Zinner, K. Tomera, and D. Gleason are study investigators funded by Praecis Pharmaceuticals, Inc. N. Zinner is a paid consultant to Praecis Pharmaceuticals, Inc. M. Campion and M. Garnick hold stock in Praecis Pharmaceuticals, Inc. N. Fotheringham and M. Garnick hold stock in Amgen, Inc., which had a licensing agreement with Praecis Pharmaceuticals, Inc. for the distribution of the mentioned product.}}, Kevin Tomera ^c,^{^{3
D. McLeod, N. Zinner, K. Tomera, and D. Gleason are study investigators funded by Praecis Pharmaceuticals, Inc. N. Zinner is a paid consultant to Praecis Pharmaceuticals, Inc. M. Campion and M. Garnick hold stock in Praecis Pharmaceuticals, Inc. N. Fotheringham and M. Garnick hold stock in Amgen, Inc., which had a licensing agreement with Praecis Pharmaceuticals, Inc. for the distribution of the mentioned product.}}, Donald Gleason ^d,^{^{3
D. McLeod, N. Zinner, K. Tomera, and D. Gleason are study investigators funded by Praecis Pharmaceuticals, Inc. N. Zinner is a paid consultant to Praecis Pharmaceuticals, Inc. M. Campion and M. Garnick hold stock in Praecis Pharmaceuticals, Inc. N. Fotheringham and M. Garnick hold stock in Amgen, Inc., which had a licensing agreement with Praecis Pharmaceuticals, Inc. for the distribution of the mentioned product.}}, Nick Fotheringham ^e, Marilyn Campion ^f, Marc B Garnick ^f
for the Abarelix Study Group
^a Walter Reed Army Medical Center, Washington, DC, USA
^b Doctors Urology Group, Torrance, California, USA
^c Alaska Urological Associates, Anchorage, Alaska, USA
^d Urological Associates of Southern Arizona, Tucson, Arizona, USA
^e Amgen Inc., Thousand Oaks, California, USA
^f Praecis Pharmaceuticals Inc., Waltham, Massachusetts, USA

^*Reprint requests: David McLeod, M.D., Walter Reed Army Medical Center, 6825 Georgia Avenue, NW, Washington, DC 20307 USA

Abstract

Objectives. To evaluate the levels of testosterone and other hormones in men with prostate cancer treated with abarelix versus leuprolide acetate.

Methods. Patients (n = 269) were randomized to receive open-label abarelix 100 mg or leuprolide acetate 7.5 mg by intramuscular injection. The results of the first 84 days of the study are reported. The primary efficacy endpoints included avoidance of testosterone surge, castration on day 8, and achievement and maintenance of castration from days 29 through 85. The secondary endpoints included castration on days 2, 4, and 15; a reduction in prostate-specific antigen level; and measurements of other hormones. Patients were monitored for clinical adverse events and laboratory abnormalities.

Results. No men in the abarelix group and 82% of men in the leuprolide acetate group experienced a testosterone surge (P <0.001). Abarelix caused rapid medical castration: 24% of men 1 day after treatment and 78% after 7 days compared with 0% of men treated with leuprolide acetate on either day. A comparable percentage of men achieved and maintained castration between days 29 and 85 in each group. Prostate-specific antigen had a statistically significant decrease for the first month in patients treated with abarelix. Dihydrotestosterone, luteinizing hormone, prostate-specific antigen, and follicle-stimulating hormone showed similar rapid reductions without an initial increase. The overall occurrence of adverse events was similar across the treatment groups, and most were sequelae of comorbid disorders.

Conclusions. Treatment with abarelix produced a higher percentage of patients who avoided a testosterone surge and had a more rapid time to testosterone suppression with a higher rate of medical castration 1 day after treatment and greater reductions in testosterone, luteinizing hormone, follicle-stimulating hormone, and dihydrotestosterone during the first 2 weeks of treatment compared with leuprolide acetate. The achievement and maintenance of castration was comparable between the two groups.

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Efficacy measurements

This study was funded through an unrestricted educational grant from Praecis Pharmaceuticals, Inc.

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Vol 58 - N° 5

P. 756-761 - novembre 2001 Retour au numéro

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Evaluation of prostate volume by transrectal ultrasonography for use in a brachytherapy program
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Molecular prediction of progression in patients with conservatively managed prostate cancer
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A phase 3, multicenter, open-label, randomized study of abarelix versus leuprolide acetate in men with prostate cancer - 03/09/11

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