Dutasteride Followed By Ultrasound-Guided Biopsy in Finding Prostate Cancer - Full Text View

Sponsor:	Kimmel Cancer Center (KCC)
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00398281

Purpose

RATIONALE: Diagnostic procedures, such as ultrasound-guided biopsy, may help find prostate cancer. Dutasteride may improve the ability of ultrasound-guided biopsy to find prostate cancer. It is not yet known whether dutasteride followed by ultrasound-guided biopsy is more effective than a placebo followed by ultrasound-guided biopsy in finding prostate cancer.

PURPOSE: This randomized phase III trial is studying dutasteride and ultrasound-guided biopsy to see how well they find prostate cancer compared with a placebo and ultrasound-guided biopsy.

Condition	Intervention	Phase
Prostate Cancer	Drug: dutasteride Other: placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Masking: Double-Blind Primary Purpose: Diagnostic
Official Title:	Detection of Prostate Cancer With Contrast-Enhanced Ultrasound After Treatment With Dutasteride

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer Ultrasound

Drug Information available for: Dutasteride

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Efficacy of short-term dutasteride in improving prostate cancer detection [ Designated as safety issue: No ]
Detection rate of prostate cancer [ Designated as safety issue: No ]
Cost effectiveness of contrast-enhanced ultrasound [ Designated as safety issue: No ]

Estimated Enrollment:	450
Study Start Date:	November 2006
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm I Patients receive oral dutasteride once daily on days 1-14.	Drug: dutasteride Given orally
Placebo Comparator: Arm II Patients receive oral placebo once daily on days 1-14.	Other: placebo Given orally

Detailed Description:

OBJECTIVES:

Determine the efficacy of dutasteride followed by contrast-enhanced, ultrasound-guided targeted biopsy in detecting prostate cancer.
Determine the detection rate of prostate cancer with targeted biopsy using contrast-enhanced ultrasound combined with dutasteride.
Determine the efficacy of targeted biopsy using contrast-enhanced ultrasound vs systematic biopsy in diagnosing clinically significant prostate cancer.
Determine the reduction in post-biopsy bleeding after dutasteride in these patients.
Determine the cost effectiveness of this regimen in these patients.

OUTLINE: This is a prospective, double-blind, placebo-controlled, randomized study. Patients are randomized to 1 of 2 arms.

Arm I: Patients receive oral dutasteride once daily on days 1-14.
Arm II: Patients receive oral placebo once daily on days 1-14. On day 14, patients in both arms undergo blood collection and contrast-enhanced (perflutren protein-type A microspheres) transrectal ultrasound. Conventional gray-scale imaging, color Doppler imaging, and power Doppler imaging are performed. Biopsies are then performed; first up to 6 targeted ultrasound-guided biopsies and then up to 12 systematic biopsies.

After completion of study procedures, patients are followed at 1 day.

PROJECTED ACCRUAL: A total of 450 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Suspected prostate cancer due to 1 of the following criteria:
- Prior abnormal digital rectal exam
- Elevated prostate-specific antigen (PSA) ≥ 2.6 ng/mL within the past 90 days
- PSA velocity > 0.75 ng/mL/year
Must be planning to undergo a transrectal ultrasound with biopsy

PATIENT CHARACTERISTICS:

Must be in adequate physical health to tolerate a prolonged transrectal examination and biopsy
Must not be clinically unstable, severely ill, or moribund

PRIOR CONCURRENT THERAPY:

More than 30 days since prior biopsy of the prostate
More than 1 week since prior acetylsalicylic acid or blood thinner
More than 30 days since prior participation in a clinical trial involving an investigational drug
No prior therapy for prostate cancer
No other concurrent 5-alpha reductase inhibitor

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00398281

Locations

United States, Pennsylvania
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia	Recruiting
Philadelphia, Pennsylvania, United States, 19107-5541
Contact: Clinical Trials Office - Kimmel Cancer Center at Thomas Jeffer 215-955-6084

Sponsors and Collaborators

Kimmel Cancer Center (KCC)

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Ethan J. Halpern, MD

Kimmel Cancer Center (KCC)

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Ethan J. Halpern, Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
ClinicalTrials.gov Identifier:	NCT00398281 History of Changes
Obsolete Identifiers:	NCT00330057
Other Study ID Numbers:	CDR0000513051, TJUH-06F-145
Study First Received:	November 9, 2006
Last Updated:	June 9, 2009
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

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
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012