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Clinical Trials/NCT00403000
NCT00403000CompletedPhase 2

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

Roswell Park Cancer Institute2 sites in 1 country27 target enrollmentStarted: December 2004Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
27
Locations
2
Primary Endpoint
Time to disease progression
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Time to disease progression

Time Frame: Every 12 weeks

Toxicity

Time Frame: Daily while on Treatment

Secondary Outcomes

  • Objective response (complete and partial) rate and serum prostate-specific antigen levels(Every 4 weeks)
  • Survival(Every 12 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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