|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | Fred Hutchinson Cancer Research Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00516815 |
Purpose
RATIONALE: Androgens can cause the growth of prostate cancer cells. Hormone therapy using dutasteride and androgen ablation therapy may fight prostate cancer by blocking the use of androgens by the tumor cells.
PURPOSE: This randomized phase II trial is studying how well giving dutasteride together with androgen ablation therapy works in treating patients with localized prostate cancer who have undergone radiation therapy and/or surgery.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: dutasteride Other: placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control |
| Official Title: | Multicentre, Double-Blind Study Comparing 0.5mg Dutasteride vs. Placebo Daily in Men Receiving Intermittent Androgen Ablation Therapy for Prostate Cancer |
| Estimated Enrollment: | 100 |
| Study Start Date: | December 2006 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Arm I: Experimental
Patients receive oral dutasteride once daily for up to 9 months* in the absence of disease progression or unacceptable toxicity. *Patients with a serum PSA value < 1.0 ng/mL at the end of 9 months continue dutasteride once daily for up to 21 months until serum PSA increases to ≥ 5.0 ng/mL.
|
Drug: dutasteride
given orally
|
|
Arm II: Placebo Comparator
Patients receive oral placebo once daily for up to 9 months in the absence of disease progression or unacceptable toxicity.
|
Other: placebo
given orally
|
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms. All patients receive intermittent androgen-ablation therapy (IAAT) comprising oral bicalutamide once daily, beginning concurrently with study medication, for 9 months and a depot injection of luteinizing hormone-releasing hormone analog once every 3 months for 9 months beginning at 3 months after initiation of study medication. An off-treatment interval (i.e., off IAAT) follows after completion of 9 months of IAAT.
NOTE: *Patients with a serum PSA value < 1.0 ng/mL at the end of 9 months continue dutasteride once daily for up to 21 months until serum PSA increases to ≥ 5.0 ng/mL.
Patients undergo blood sample collection at baseline and periodically for pharmacodynamic analysis. Samples are analyzed for circulating levels of serum testosterone and dihydrotestosterone.
Quality of life is assessed at baseline and 9 or 24 months.
Eligibility| Ages Eligible for Study: | 45 Years to 80 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate
Minimum of 3 PSA values above the nadir PSA measured ≥ 1 month apart after treatment AND meets 1 of the following criteria:
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
Unstable serious concurrent medical conditions including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
No prior treatment for prostate cancer with any of the following:
Hormonal therapy (e.g., megestrol, medroxyprogesterone, cyproterone, or diethylstilbestrol) within the past year
More than 1 year since prior and no concurrent use of the following medications:
Over-the-counter or herbal preparations such as cimetidine, saw palmetto, selenium (> 75 mcg), or vitamin E (> 100 IU)
Contacts and Locations| United States, Washington | |
| Cascade Cancer Center at Evergreen Hospital Medical Center | Recruiting |
| Kirkland, Washington, United States, 98034-3013 | |
| Contact: Brenda Havens 425-899-3181 bhavens@cascadecancercenter.com | |
| Floyd and Delores Jones Cancer Institute at Virginia Mason Medical Center | Recruiting |
| Seattle, Washington, United States, 98101 | |
| Contact: Jacqueline Vuky, MD 206-223-6193 jacqueline.vuky@vmmc.org | |
| Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Recruiting |
| Seattle, Washington, United States, 98195-6043 | |
| Contact: Alma MacAraeg 206-288-1349 almam@u.washington.edu | |
| University Cancer Center at University of Washington Medical Center | Recruiting |
| Seattle, Washington, United States, 98195-6043 | |
| Contact: Alma MacAraeg 206-288-1349 almam@u.washington.edu | |
| Skagit Valley Hospital Cancer Care Center | Recruiting |
| Mount Vernon, Washington, United States, 98273 | |
| Contact: Robert J. Raish, MD 360-428-2146 | |
| MultiCare Regional Cancer Center at Tacoma General Hospital | Recruiting |
| Tacoma, Washington, United States, 98405 | |
| Contact: Richard Shine, PharmD 253-403-7250 Richard.Shine@multicare.org | |
| Principal Investigator: | Celestia S. Higano, MD | Seattle Cancer Care Alliance |
More Information
| Responsible Party: | Canadian Urology Research Consortium ( Regulatory Affairs Associate ) |
| Study ID Numbers: | CDR0000561073, UWCC-6408, UWCC-UW 6408, UWCC- 06-4211-H/B |
| Study First Received: | August 14, 2007 |
| Last Updated: | November 19, 2009 |
| ClinicalTrials.gov Identifier: | NCT00516815 History of Changes |
| Health Authority: | Unspecified |
|
stage I prostate cancer stage II prostate cancer recurrent prostate cancer adenocarcinoma of the prostate stage III 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 |