NCT00403000

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	dutasteride	Oral

Timeline

• Start date: 2004-12-01
• Primary completion: 2007-03-01
• Completion: 2013-04-01
• First posted: 2006-11-23
• Last updated: 2013-05-01

Locations

1 site across 1 country: United States