Spots Global Cancer Trial Database for Dutasteride in Treating Patients With Recurrent Prostate Cancer That Did Not Respond to Androgen-Deprivation Therapy

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Trial Identification

Brief Title: Dutasteride in Treating Patients With Recurrent Prostate Cancer That Did Not Respond to Androgen-Deprivation Therapy

Official Title: Phase II Study of Dutasteride in Prostate Cancer Recurrent During Androgen Deprivation Therapy

Study ID: NCT00403000

Conditions

Prostate Cancer

Interventions

dutasteride

Study Description

Brief Summary: 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.

Detailed Description: OBJECTIVES: Primary * Evaluate the time to disease progression in patients with recurrent prostate cancer that progressed during androgen-deprivation therapy who are treated with dutasteride. * Evaluate the toxicity of dutasteride in these patients. Secondary * Evaluate the serum prostate-specific antigen (PSA) level and objective radiographic response rate in patients treated with dutasteride. * Determine the survival of patients treated with dutasteride. * Determine the quality of life of patients treated with dutasteride. 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.