Dutasteride Followed By Ultrasound-Guided Biopsy in Finding Prostate Cancer

NCT00398281 | Completed Phase 3

• 2 other identifiers: CDR0000513051TJUH-06F-145
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

prostate cancer

Outcome Measures

Primary Outcomes (3)

• Efficacy of short-term dutasteride in improving prostate cancer detection

• Detection rate of prostate cancer

• Cost effectiveness of contrast-enhanced ultrasound

Study Arms (2)

Arm I

EXPERIMENTAL

Patients receive oral dutasteride once daily on days 1-14.

Drug: dutasteride

Arm II

PLACEBO COMPARATOR

Patients receive oral placebo once daily on days 1-14.

Other: placebo

Interventions

dutasteride DRUG

Given orally

Arm I

placebo OTHER

Given orally

Arm II

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Sidney Kimmel Cancer Center at Thomas Jefferson University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, 19107-5541, United States

Location

Related Publications (1)

• Halpern EJ, Gomella LG, Forsberg F, McCue PA, Trabulsi EJ. Contrast enhanced transrectal ultrasound for the detection of prostate cancer: a randomized, double-blind trial of dutasteride pretreatment. J Urol. 2012 Nov;188(5):1739-45. doi: 10.1016/j.juro.2012.07.021. Epub 2012 Sep 19.

  PMID: 22998915 DERIVED

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

Study Officials

• Ethan J. Halpern, MD

  Sidney Kimmel Cancer Center at Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: DIAGNOSTIC
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 9, 2006
• First Posted: November 10, 2006
• Study Start: November 1, 2006
• Primary Completion: July 1, 2010
• Study Completion: September 1, 2012
• Last Updated: January 10, 2014

Record last verified: 2009-06

Locations

US (1)