Abstract | OBJECTIVE: To evaluate the efficacy and tolerability of a once-yearly histrelin implant during an open-label extension of a pivotal study. PATIENTS AND METHODS: RESULTS: Of 104 patients enrolled, over 70% received three consecutive histrelin implants, and the longest, single treatment period was greater than 4 years. Serum testosterone was consistently suppressed below 50 ng/dL in all patients and mean testosterone levels were 13.1, 14.8 and 10.8 ng/dL after 104 weeks (year 2), 156 weeks (year 3) and 208 weeks (year 4) of treatment, respectively. Most patients showed no clinical worsening of their disease, were able to continue normal daily activities, and did not require analgesic medication during the extension period. Mean (SD) time to place the histrelin implant was 4.5 (6.2) min, with only three patients having insertions that were considered difficult. Adverse events were reported in 100 (96.2%) patients. The eight deaths and 28 (26.9%) serious adverse events were judged as unrelated to the study drug. The most commonly reported drug-related adverse events was hot flashes in 67 (64.4%) patients. Most of these cases was judged as mild or moderate. CONCLUSIONS:
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Authors | Neal Shore, Michael S Cookson, Marc C Gittelman |
Journal | BJU international
(BJU Int)
Vol. 109
Issue 2
Pg. 226-32
(Jan 2012)
ISSN: 1464-410X [Electronic] England |
PMID | 21851539
(Publication Type: Clinical Trial, Journal Article)
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Copyright | © 2011 THE AUTHORS. BJU INTERNATIONAL © 2011 BJU INTERNATIONAL. |
Chemical References |
- Drug Implants
- Gonadotropin-Releasing Hormone
- Testosterone
- histrelin
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Topics |
- Aged
- Disease Progression
- Drug Implants
- Follow-Up Studies
- Gonadotropin-Releasing Hormone
(administration & dosage, adverse effects, agonists, analogs & derivatives, pharmacology)
- Humans
- Male
- Palliative Care
(methods)
- Prostatic Neoplasms
(drug therapy)
- Testosterone
(blood)
- Treatment Outcome
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