Abstract | OBJECTIVES: METHODS: For 168 days, 81 patients from 17 centers received monthly intramuscular injections of open-label abarelix 100 mg (at least one dose). Patients were evaluated for the avoidance of bilateral orchiectomy, efficacy, disease response, percentage of change in prostate-specific antigen level, change in the intensity of pain, neurologic compromise, and other efficacy variables. Safety was evaluated through reports of adverse events and abnormal laboratory values. RESULTS: No patients required bilateral orchiectomy, but 2 patients were withdrawn from the study because of treatment-related events and were considered as failures to avoid orchiectomy. Treatment produced an 88% (38 of 43) objective response rate on day 85. Sixty-five (90%) of 72 patients experienced improvement in the pain score and/or analgesic use, urinary obstruction, urinary catheter removal, hydronephrosis, and/or azotemia. No patient with impending neurologic compromise at study entry developed spinal cord compression. The median reduction from the baseline prostate-specific antigen value was 75% on day 15 and greater than 95% from day 57 onward. Abarelix was well tolerated, and adverse events were the sequelae of advanced prostate cancer, comorbid medical disorders, or medical castration. CONCLUSIONS:
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Authors | Michael Koch, Christopher Steidle, Stanley Brosman, Arthur Centeno, Franklin Gaylis, Marilyn Campion, Marc B Garnick, Abarelix Study Group |
Journal | Urology
(Urology)
Vol. 62
Issue 5
Pg. 877-82
(Nov 2003)
ISSN: 1527-9995 [Electronic] United States |
PMID | 14624912
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antineoplastic Agents, Hormonal
- Biomarkers, Tumor
- Hormone Antagonists
- Oligopeptides
- Gonadotropin-Releasing Hormone
- Testosterone
- Prostate-Specific Antigen
- abarelix
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Topics |
- Adenocarcinoma
(blood, complications, drug therapy)
- Adult
- Aged
- Aged, 80 and over
- Antineoplastic Agents, Hormonal
(therapeutic use)
- Biomarkers, Tumor
(blood)
- Gonadotropin-Releasing Hormone
(antagonists & inhibitors)
- Hormone Antagonists
(adverse effects, therapeutic use)
- Humans
- Male
- Middle Aged
- Oligopeptides
(therapeutic use)
- Pain Measurement
- Prostate-Specific Antigen
(blood)
- Prostatic Neoplasms
(blood, complications, drug therapy)
- Safety
- Testosterone
(blood)
- Treatment Outcome
- Urinary Bladder Neck Obstruction
(etiology)
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