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| Sponsor: | Roswell Park Cancer Institute |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00403000 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: dutasteride |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Phase II Study of Dutasteride in Prostate Cancer Recurrent During Androgen Deprivation Therapy |
| Estimated Enrollment: | 27 |
| Study Start Date: | December 2004 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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:
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 concurrent use of any of the following:
Contacts and Locations| United States, New York | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263-0001 | |
| Principal Investigator: | James L. Mohler, MD | Roswell Park Cancer Institute |
More Information
| Study ID Numbers: | CDR0000514492, RPCI-I-34904 |
| Study First Received: | November 21, 2006 |
| Last Updated: | April 21, 2009 |
| ClinicalTrials.gov Identifier: | NCT00403000 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent prostate cancer |
|
Molecular Mechanisms of Pharmacological Action Genital Neoplasms, Male Prostatic Diseases Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Enzyme Inhibitors Urogenital Neoplasms Genital Diseases, Male |
Hormones Pharmacologic Actions Dutasteride Neoplasms Neoplasms by Site Prostatic Neoplasms Androgens |