|
|
|
|
|
|
Sponsors and Collaborators: |
Fred Hutchinson Cancer Research Center National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00516815 |
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 Drug: placebo |
Phase II |
MedlinePlus related topics: | Cancer Prostate Cancer |
ChemIDplus related topics: | Dutasteride |
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.
|
Drug: 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.
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:
United States, Montana | |||||
Great Falls Clinic Specialty Center | Recruiting | ||||
Great Falls, Montana, United States, 59405 | |||||
Contact: Clinical Trials Office - Great Falls Clinic Specialty Center research@gfclinic.com | |||||
United States, Washington | |||||
Cascade Cancer Center at Evergreen Hospital Medical Center | Recruiting | ||||
Kirkland, Washington, United States, 98034-3013 | |||||
Contact: Michele Frank, MD 425-899-3181 | |||||
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 | |||||
Northwest Medical Specialties, PLLC - Tacoma | Recruiting | ||||
Tacoma, Washington, United States, 98405 | |||||
Contact: Francis M. Senecal, MD 253-383-3366 fmsenecal@hotmail.com | |||||
Olympic Medical Center | Recruiting | ||||
Port Angeles, Washington, United States, 98362 | |||||
Contact: Robert Witham, MD 360-417-7139 | |||||
Wenatchee Valley Medical Center | Recruiting | ||||
Wenatchee, Washington, United States, 98801-2028 | |||||
Contact: Clinical Trials Office - Wenatchee Valley Medical Center 509-665-5800 | |||||
Seattle Cancer Care Alliance | Recruiting | ||||
Seattle, Washington, United States, 98109-1023 | |||||
Contact: Clinical Trials Office - Seattle Cancer Care Alliance 800-804-8824 | |||||
Skagit Valley Hospital Cancer Care Center | Recruiting | ||||
Mount Vernon, Washington, United States, 98273 | |||||
Contact: Robert J. Raish, MD 360-428-2146 | |||||
University Cancer Center at University of Washington Medical Center | Recruiting | ||||
Seattle, Washington, United States, 98195-6043 | |||||
Contact: Clinical Trials Office - University Cancer Center at Universit 206-616-8289 | |||||
Rainier Physicians - NWMS | Recruiting | ||||
Puyallup, Washington, United States, 98372 | |||||
Contact: Robert D. McCroskey, MD 253-697-4800 rmccroskey@rainieroncology.com |
Fred Hutchinson Cancer Research Center |
National Cancer Institute (NCI) |
Principal Investigator: | Celestia S. Higano, MD | University of Washington |
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
Study ID Numbers: | CDR0000561073, FHCRC-6408, UWCC-UW 6408, UWCC- 06-4211-H/B |
First Received: | August 14, 2007 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00516815 |
Health Authority: | Unspecified |
|
|
|
|