Role of Dutasteride in Patients Undergoing 3D Mapping Biopsy in Early Stage Prostate Cancer
This study has been terminated.
(Low recruitment)
Sponsor:
University of Colorado, Denver
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00985738
First received: September 11, 2009
Last updated: April 15, 2016
Last verified: March 2016
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Purpose
The purpose of this study is to determine the effect of short-term intake of daily Dutasteride in patients with prostate cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: Dutasteride Other: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomized Placebo-Controlled Double-Blind Clinical Trial to Assess the Role of Dutasteride in Patients Undergoing 3D Mapping Biopsy in Early Stage Prostate Cancer |
Resource links provided by NLM:
Genetics Home Reference related topics:
prostate cancer
Drug Information available for:
Dutasteride
U.S. FDA Resources
Further study details as provided by University of Colorado, Denver:
Primary Outcome Measures:
- To Determine the Effect of Short-term Intake of Daily Dutasteride Prostate Cancer Volume, Distribution Within the Gland and Gleason Score Sum in Patients in Comparison to Placebo After Adjusting for Changes in Prostate Gland Volume. [ Time Frame: 24 Months ] [ Designated as safety issue: No ]The effect of Dutasteride intake on the following parameters as detected by mapping biopsy vs. initial trans-rectal biopsy in the treatment arm and the control group: change in prostate gland volume, change in distribution within the gland, and change in Gleason score sum.
| Enrollment: | 16 |
| Study Start Date: | September 2009 |
| Study Completion Date: | January 2013 |
| Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Dutasteride
The drug, Dutasteride, will be administered at 0.5 mg dose and given everyday (QD), for 3 months.
|
Drug: Dutasteride
Dutasteride will be administered at 0.5 mg dose and it will be given every day (QD), for approximately 3 months, followed by 3D mapping biopsy.
Other Name: Avodart
|
|
Placebo Comparator: Placebo
The placebo group will receive a placebo drug for 3 months, instead of the intervention drug, Dutasteride.
|
Other: Placebo
The placebo group will receive the same standard of care as the intervention group, but instead of receiving the intervention drug, Dutasteride, participants will receive a placebo drug for the same 3 month period.
|
Detailed Description:
This is a study of men who have undergone a standard 10 or more core biopsy for detection of prostate cancer and determined to have prostate cancer by having a Gleason score ≤ 7 (low to moderate risk 2-7). Of these men, one arm of a two arm randomized group will be administered a treatment regime of Dutasteride versus the control group who receive standard of care, prior to mapping biopsy. This proposal aims at studying the apparent effect of the use of Dutasteride (3 months) on initial tumor volume (at diagnosis) in men with low volume cancer before undergoing 3D mapping biopsy.
Eligibility| Ages Eligible for Study: | 40 Years to 85 Years (Adult, Senior) |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 40-85 year old males
- Patient is newly diagnosed with clinical Stage T1a-T2c prostate cancer based on transrectal guided extended prostate biopsy of at least 10 cores.
- Patient elects to undergo 3D mapping biopsy at our center as part of prostate cancer management.
- Patient will read, understand and sign the informed consent agreement
- Patients must have a life expectancy of at least one year.
- Gleason score ≤ 7 (low to moderate risk 2-7) 7= 3+4
- Percentage positive core rate < 50% based on sextant or extended biopsy technique.
- Prostate Volume (PV) >15 grams.
- Negative imaging studies ( if available) during the staging period such as Bone scan, MRI and CT scan if PSA> 10 ng.dl before initiation of the study drug
Exclusion Criteria:
- Any 5α-reductase inhibitors medications within the past 12 months before enrollment.
- Known hypersensitivity to dutasteride, or other 5α-reductase inhibitors.
- Anticipated blood donation within the next 90 days.
- Serum PSA levels of >20ng/dl.
- Clinical evidence of metastatic prostate cancer.
- Two documented urinary tract infections in the past year
- CHF, MI (within 6 months) or other symptomatic CVS disease
- Other serious diseases (hematological, hepatic, renal, respiratory or psychiatric)
- Enrollment in other studies for any disease in the past 30 days
- Significant urinary incontinence
- Diagnosis of cancer that in not considered cured, except BCC of skin
- Prior transurethral resection of the prostate with a large tissue defect.
- History of abdominoperineal resection for rectal cancer, rectal stenosis, or other major rectal pathology
- Previous or concurrent radiotherapy, hormonal therapy or chemotherapy
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00985738
Please refer to this study by its ClinicalTrials.gov identifier: NCT00985738
Locations
| United States, Colorado | |
| University of Colorado Hospital | |
| Aurora, Colorado, United States, 80045 | |
Sponsors and Collaborators
University of Colorado, Denver
GlaxoSmithKline
Investigators
| Principal Investigator: | Al Barqawi, MD | University of Colorado, Denver |
More Information
Additional Information:
| Responsible Party: | University of Colorado, Denver |
| ClinicalTrials.gov Identifier: | NCT00985738 History of Changes |
| Other Study ID Numbers: | 09-0247.cc |
| Study First Received: | September 11, 2009 |
| Results First Received: | March 16, 2016 |
| Last Updated: | April 15, 2016 |
| Health Authority: | United States: Food and Drug Administration |
| Individual Participant Data | |
| Plan to Share IPD: | No |
Keywords provided by University of Colorado, Denver:
|
Prostate Cancer Early Stage Prostate Cancer |
Additional relevant MeSH terms:
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Dutasteride |
5-alpha Reductase Inhibitors Steroid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 26, 2016