Role of Dutasteride in Patients Undergoing 3D Mapping Biopsy in Early Stage Prostate Cancer

• ClinicalTrials.gov Identifier: NCT00985738
• Recruitment Status: Terminated
• First Posted: September 28, 2009
• Results First Posted: April 18, 2016
• Last Update Posted: May 17, 2016
• Sponsor: University of Colorado, Denver
• Collaborator: GlaxoSmithKline
• Information provided by (Responsible Party): University of Colorado, Denver

Study Description

Brief Summary:

The purpose of this study is to determine the effect of short-term intake of daily Dutasteride in patients with prostate cancer.

Condition or disease	Intervention/treatment	Phase
Prostate Cancer	Drug: Dutasteride; Other: Placebo	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, 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
• Study Start Date: September 2009
• Actual Primary Completion Date: January 2013
• Actual Study Completion Date: January 2013

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. 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 ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 85 Years (Adult, Older Adult)
• Sexes 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

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:

The link above provides detail about the Primary Investigator (PI- Al Barqawi MD FRCS) and his research on prostate cancer. In addition, this website includes the PI's resume and publications. 

• Responsible Party: University of Colorado, Denver
• ClinicalTrials.gov Identifier: NCT00985738
• Other Study ID Numbers: 09-0247.cc
• First Posted: September 28, 2009
• Results First Posted: April 18, 2016
• Last Update Posted: May 17, 2016
• Last Verified: March 2016

Individual Participant Data (IPD) Sharing Statement:

• 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; 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