Phase II study of Dutasteride for recurrent prostate cancer during androgen deprivation therapy.
J Urol
; 181(2): 621-6, 2009 Feb.
Article
em En
| MEDLINE
| ID: mdl-19091347
ABSTRACT
PURPOSE:
We determined the response rate to and safety of a dual 5alpha-reductase inhibitor, dutasteride, in men with castration recurrent prostate cancer. MATERIALS ANDMETHODS:
A total of 28 men with asymptomatic castration recurrent prostate cancer were treated with 3.5 mg dutasteride daily (luteinizing hormone-releasing hormone treatment continued), and evaluated monthly for response and toxicity. Eligibility included appropriate duration antiandrogen withdrawal, baseline prostate specific antigen 2.0 ng/ml or greater and a new lesion on bone scan, increase in measurable disease using Response Evaluation Criteria in Solid Tumors criteria, or 2 or more consecutive prostate specific antigen measurements increased over baseline. Outcomes were progression, stable disease, partial response (prostate specific antigen less than 50% of enrollment for 4 or more weeks) or complete response.RESULTS:
There were 25 evaluable men with a mean age of 70 years (range 57 to 88), a mean prostate specific antigen of 61.9 ng/ml (range 5.0 to 488.9) and mean Gleason score 8 (range 6 to 10), 15 of whom had bone metastases. Eight men had 10 grade 3 or higher adverse events using National Cancer Institute Common Terminology Criteria, all of which were judged to be unrelated to treatment. Of the 25 men 14 had disease progression by 2 months, 9 had stable (2.5, 3, 3, 4, 4, 5, 5, 8.5, 9 months) disease, 2 had a partial response and none had a complete response. Overall median time to progression was 1.87 months (range 1 to 10, 95% CI 1.15-3.91).CONCLUSIONS:
Dutasteride rarely produces biochemical responses in men with castration recurrent prostate cancer. However, further study is warranted given its favorable safety profile.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Neoplasias da Próstata
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Azasteroides
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Inibidores de 5-alfa Redutase
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Recidiva Local de Neoplasia
Tipo de estudo:
Etiology_studies
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Observational_studies
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Prognostic_studies
Limite:
Aged
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Aged80
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
J Urol
Ano de publicação:
2009
Tipo de documento:
Article
País de afiliação:
Estados Unidos