Abstract | PURPOSE: MATERIALS AND METHODS: In this phase 2 open label study 242 patients with prostate cancer requiring initial hormonal treatment received abarelix depot (209) or LH-RH agonists (33) with or without antiandrogen. A total of 100 mg. abarelix depot was delivered intramuscularly every 28 days with an additional injection on day 15. LH-RH agonists with or without antiandrogen were administered according to the depot formulation used. Endocrine efficacy was measured by the absence of testosterone surge and rapidity of castration onset. The rate of prostate specific antigen decrease was assessed. RESULTS: No patient treated with abarelix depot had testosterone surge during week 1 compared with 82% of those treated with LH-RH agonists. The concomitant administration of antiandrogen had no effect. During the first week of drug administration, in 75% of patients treated with abarelix depot and in 0% of those treated with LH-RH agonist medical castration was achieved. Prostate specific antigen decrease was faster, with no flare or surge in patients treated with abarelix depot. Abarelix depot was well tolerated. CONCLUSIONS:
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Authors | K Tomera, D Gleason, M Gittelman, W Moseley, N Zinner, M Murdoch, M Menon, M Campion, M B Garnick |
Journal | The Journal of urology
(J Urol)
Vol. 165
Issue 5
Pg. 1585-9
(May 2001)
ISSN: 0022-5347 [Print] United States |
PMID | 11342922
(Publication Type: Clinical Trial, Clinical Trial, Phase II, Comparative Study, Journal Article, Research Support, Non-U.S. Gov't)
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Chemical References |
- Androgen Antagonists
- Antineoplastic Agents, Hormonal
- Delayed-Action Preparations
- Oligopeptides
- Dihydrotestosterone
- Goserelin
- Gonadotropin-Releasing Hormone
- Testosterone
- Luteinizing Hormone
- Follicle Stimulating Hormone
- Prostate-Specific Antigen
- Leuprolide
- abarelix
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Topics |
- Aged
- Aged, 80 and over
- Androgen Antagonists
(therapeutic use)
- Antineoplastic Agents, Hormonal
(therapeutic use)
- Delayed-Action Preparations
- Dihydrotestosterone
(blood)
- Follicle Stimulating Hormone
(blood)
- Gonadotropin-Releasing Hormone
(agonists, antagonists & inhibitors)
- Goserelin
(therapeutic use)
- Humans
- Injections, Intramuscular
- Leuprolide
(therapeutic use)
- Luteinizing Hormone
(blood)
- Male
- Middle Aged
- Oligopeptides
(administration & dosage, therapeutic use)
- Prospective Studies
- Prostate-Specific Antigen
(blood)
- Prostatic Neoplasms
(blood, diagnosis, drug therapy)
- Testis
(drug effects)
- Testosterone
(blood)
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