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RATIONALE: Dutasteride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well dutasteride works in treating patients with recurrent prostate cancer that did not respond to androgen-deprivation therapy.
Full description
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive oral dutasteride once daily until disease progression or unacceptable toxicity.
Quality of life is assessed at baseline and then every 3 months thereafter.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 27 patients will be accrued for this study.
Enrollment
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Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Diagnosis of prostate cancer
Asymptomatic progressive disease despite androgen-deprivation therapy
Progression must occur during androgen-deprivation therapy comprising orchiectomy or luteinizing hormone-releasing hormone (LHRH) analogue with or without antiandrogen AND after antiandrogen withdrawal
Recurrent disease, as indicated by at least 1 of the following:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
At least 28 days since prior radiotherapy and recovered
At least 28 days since prior flutamide OR at least 42 days since prior bicalutamide or nilutamide
No other prior systemic therapies, except androgen-deprivation therapy (i.e., orchiectomy or LHRH analogues only) or antiandrogens
No other concurrent anticancer therapy
No concurrent use of any of the following:
No concurrent radiotherapy, including palliative radiotherapy for pain control
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Data sourced from clinicaltrials.gov
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