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

NCT00985738 | Terminated Phase 2 Results DMC

• 1 other identifier: 09-0247.cc
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Prostate Cancer

Keywords

Prostate Cancer; Early Stage Prostate Cancer

Outcome Measures

Primary Outcomes (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.

  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.

  24 Months

Study Arms (2)

Dutasteride

EXPERIMENTAL

The drug, Dutasteride, will be administered at 0.5 mg dose and given everyday (QD), for 3 months.

Drug: Dutasteride

Placebo

PLACEBO COMPARATOR

The placebo group will receive a placebo drug for 3 months, instead of the intervention drug, Dutasteride.

Other: Placebo

Interventions

Dutasteride DRUG

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.

Also known as: Avodart

Dutasteride

Placebo OTHER

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.

Placebo

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Related Links

• 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.

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Dutasteride

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Azasteroids; Steroids, Heterocyclic; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Limitations and Caveats

This study was terminated due to low accrual.

Results Point of Contact

• Title: Dr. Al Baha Barqawi
• Organization: University of Colorado Hospital

AL.BARQAWI@UCDENVER.EDU

303-724-2722

Study Officials

• Al Barqawi, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2009
• First Posted: September 28, 2009
• Study Start: September 1, 2009
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: May 17, 2016
• Results First Posted: April 18, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)