Assessment Of Dutasteride (AVODART) In Extending The Time To Progression Of Low-Risk, Localized Prostate Cancer In Men

NCT ID: NCT00363311

Last Updated: 2017-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 302 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-31
• Study Completion Date: 2010-07-31

Brief Summary

The purpose of this study is to examine the effect of dutasteride on the inhibition of low-risk, localized prostate cancer progression in men who would otherwise receive no active therapy (expectant management).

Conditions

Neoplasms, Prostate

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Dutasteride

Dutasteride 0.5mg

Group Type: ACTIVE_COMPARATOR

Dutasteride

Intervention Type: DRUG

Dutasteride 0.5mg

Placebo

Matching placebo

Group Type: PLACEBO_COMPARATOR

Matching placebo

Intervention Type: DRUG

Matching placebo

Interventions

Dutasteride

Dutasteride 0.5mg

Intervention Type: DRUG

Matching placebo

Matching placebo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Must be male ≥48 and ≤82 years of age
• Have biopsy proven, low-risk, localized prostate cancer and active in expectant management not more than 14 months. [For the purposes of assessing subject eligibility a diagnostic biopsy must have included at least 10 cores, (< 4 cores positive and <50% of any one core positive) and must have been obtained within 8 months of screening]. If a saturation biopsy was performed (20 or more cores obtained) 2-3 cores are to be positive for prostate cancer and with <50% of any one core positive. Initial diagnosis of T1a/T1b obtained during a Transrectal ultrasound (TURP) is not allowed.
• Gleason score ≤6 [Gleason pattern 4 or above must not be present on any biopsy (initial or entry)]
• Clinical stage T1c-T2a
• Serum Prostate Specific Antigen (PSA) ≤11ng/mL. If the screening PSA value from the central laboratory is greater than 11ng/ml, one PSA retest is allowed through the central laboratory
• A life expectancy greater than five years.
• Able to swallow and retain oral medication
• Able and willing to participate in the full 3 years of the study
• Able to read and write (health outcomes questionnaires are self-administered), understand instructions related to study procedures and give written informed consent.

Exclusion Criteria

• Subject has ever been treated for prostate cancer with any of the following:
• Radiotherapy (external beam or brachytherapy)
• Chemotherapy
• Hormonal therapy (e.g., megestrol, medroxyprogesterone, cyproterone, diethylstilbestrol (DES)
• Oral glucocorticoids
• Gonadotropin-releasing hormone (GnRH) analogues (e.g., leuprolide, goserelin)
• Glucocorticoids, except inhaled or topical, are not permitted within 3 months prior to visit one
• Current and/or previous use of the following medications:
• Finasteride (Proscar, Propecia), or Dutasteride (GI198745, AVODART) exposure within 6 months prior to study entry are excluded.
• Any other investigational 5α-reductase inhibitors within the past 12 months.
• Anabolic steroids (subject must discontinued for 6 months prior to study entry to be eligible)
• Drugs with antiandrogenic properties within the past 6 months (e.g,. spironolactone, flutamide, bicalutamide, *cimetidine, *ketoconazole, metronidazole, progestational agents) NOTE: Use of dietary and herbal supplements (e.g., selenium, Vitamin E, saw palmetto) during the study is discouraged but not prohibited. All dietary and herbal supplement usage will be recorded in the case report form (CRF).

*The use of cimetidine is permitted prior to study entry. The use of topical ketoconazole is permitted prior to and during the study.

• Prostate volume >80 cc
• Subject has had prior prostatic surgery including Transurethral needle ablation of the prostate (TUNA), TURP, Transurethral incision of the prostate (TUIP), laser treatment, thermotherapy, balloon dilatation, prosthesis, and ultrasound ablation within 3 months of enrolment
• Severe Benign Prostatic Hyperplasia (BPH) symptoms as manifested by International Prostate Symptom Score (IPSS) symptom score (calculated using the first 7 questions only) of ≥25 or >20 if already on alpha blocker therapy.
• Participation in any investigational or marketed drug trial within the 30 days prior to the first dose of study drug or anytime during the study period.
• Any unstable serious co-existing medical condition(s) including but not limited to myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident within 6 months prior to Screening visit; uncontrolled diabetes or peptic ulcer disease which is uncontrolled by medical management.
• Abnormal liver function test (greater than 2 times the upper limit of normal for alanine aminotransferase [ALT], aspartate aminotransferase [AST], or alkaline phosphatase [ALP]); or bilirubin >1.5 times the upper limit of normal.
• Serum creatinine >1.5 times the upper limit of normal.
• History of another malignancy within five years that could affect the diagnosis of prostate cancer.
• History or current evidence of drug or alcohol abuse within the last 12 months.
• History of any illness (including psychiatric) that, in the opinion of the investigator, might confound the results of the study or pose additional risk to the subject.
• Known hypersensitivity to any 5α-reductase inhibitor or to any drug chemically related to dutasteride.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Little Rock, Arkansas, United States

GSK Investigational Site

Beverly Hills, California, United States

GSK Investigational Site

Laguna Hills, California, United States

GSK Investigational Site

Mission Hills, California, United States

GSK Investigational Site

Modesto, California, United States

GSK Investigational Site

San Bernardino, California, United States

GSK Investigational Site

Torrance, California, United States

GSK Investigational Site

Englewood, Colorado, United States

GSK Investigational Site

Wheat Ridge, Colorado, United States

GSK Investigational Site

New Britain, Connecticut, United States

GSK Investigational Site

Trumbull, Connecticut, United States

GSK Investigational Site

Washington D.C., District of Columbia, United States

GSK Investigational Site

Jacksonville, Florida, United States

GSK Investigational Site

Largo, Florida, United States

GSK Investigational Site

Orlando, Florida, United States

GSK Investigational Site

Roswell, Georgia, United States

GSK Investigational Site

Coeur d'Alene, Idaho, United States

GSK Investigational Site

Chicago, Illinois, United States

GSK Investigational Site

Melrose Park, Illinois, United States

GSK Investigational Site

Fort Wayne, Indiana, United States

GSK Investigational Site

Newburgh, Indiana, United States

GSK Investigational Site

Overland Park, Kansas, United States

GSK Investigational Site

Shreveport, Louisiana, United States

GSK Investigational Site

Annapolis, Maryland, United States

GSK Investigational Site

Greenbelt, Maryland, United States

GSK Investigational Site

Watertown, Massachusetts, United States

GSK Investigational Site

Minneapolis, Minnesota, United States

GSK Investigational Site

Saint Cloud, Minnesota, United States

GSK Investigational Site

Jackson, Mississippi, United States

GSK Investigational Site

St Louis, Missouri, United States

GSK Investigational Site

Las Vegas, Nevada, United States

GSK Investigational Site

Marlton, New Jersey, United States

GSK Investigational Site

Albuquerque, New Mexico, United States

GSK Investigational Site

Albany, New York, United States

GSK Investigational Site

Elmont, New York, United States

GSK Investigational Site

Garden City, New York, United States

GSK Investigational Site

New York, New York, United States

GSK Investigational Site

Orchard Park, New York, United States

GSK Investigational Site

Syracuse, New York, United States

GSK Investigational Site

Greensboro, North Carolina, United States

GSK Investigational Site

Salisbury, North Carolina, United States

GSK Investigational Site

Winston-Salem, North Carolina, United States

GSK Investigational Site

Columbus, Ohio, United States

GSK Investigational Site

Springfield, Oregon, United States

GSK Investigational Site

Bala-Cynwyd, Pennsylvania, United States

GSK Investigational Site

Lancaster, Pennsylvania, United States

GSK Investigational Site

Philadelphia, Pennsylvania, United States

GSK Investigational Site

Memphis, Tennessee, United States

GSK Investigational Site

Nashville, Tennessee, United States

GSK Investigational Site

San Antonio, Texas, United States

GSK Investigational Site

Temple, Texas, United States

GSK Investigational Site

Salt Lake City, Utah, United States

GSK Investigational Site

Richmond, Virginia, United States

GSK Investigational Site

Virginia Beach, Virginia, United States

GSK Investigational Site

Williamsburg, Virginia, United States

GSK Investigational Site

Seattle, Washington, United States

GSK Investigational Site

Seattle, Washington, United States

GSK Investigational Site

Spokane, Washington, United States

GSK Investigational Site

Surrey, British Columbia, Canada

GSK Investigational Site

Victoria, British Columbia, Canada

GSK Investigational Site

Victoria, British Columbia, Canada

GSK Investigational Site

Fredericton, New Brunswick, Canada

GSK Investigational Site

Barrie, Ontario, Canada

GSK Investigational Site

Brampton, Ontario, Canada

GSK Investigational Site

Brantford, Ontario, Canada

GSK Investigational Site

Burlington, Ontario, Canada

GSK Investigational Site

Burlington, Ontario, Canada

GSK Investigational Site

Guelph, Ontario, Canada

GSK Investigational Site

Kitchener, Ontario, Canada

GSK Investigational Site

North Bay, Ontario, Canada

GSK Investigational Site

Oakville, Ontario, Canada

GSK Investigational Site

Scarborough Village, Ontario, Canada

GSK Investigational Site

Toronto, Ontario, Canada

GSK Investigational Site

Toronto, Ontario, Canada

GSK Investigational Site

Toronto, Ontario, Canada

GSK Investigational Site

Chicoutimi, Quebec, Canada

GSK Investigational Site

Greenfield Park, Quebec, Canada

GSK Investigational Site

Laval, Quebec, Canada

GSK Investigational Site

Montreal, Quebec, Canada

GSK Investigational Site

Pointe-Claire, Quebec, Canada

GSK Investigational Site

Québec, Quebec, Canada

GSK Investigational Site

Trois-Rivières, Quebec, Canada

Countries

United States; Canada

References

Fleshner NE, Lucia MS, Egerdie B, Aaron L, Eure G, Nandy I, Black L, Rittmaster RS. Dutasteride in localised prostate cancer management: the REDEEM randomised, double-blind, placebo-controlled trial. Lancet. 2012 Mar 24;379(9821):1103-11. doi: 10.1016/S0140-6736(11)61619-X. Epub 2012 Jan 24.

Reference Type: BACKGROUND

PMID: 22277570 (View on PubMed)

Moreira DM, Fleshner NE, Freedland SJ. Baseline Perineural Invasion is Associated with Shorter Time to Progression in Men with Prostate Cancer Undergoing Active Surveillance: Results from the REDEEM Study. J Urol. 2015 Nov;194(5):1258-63. doi: 10.1016/j.juro.2015.04.113. Epub 2015 May 16.

Reference Type: DERIVED

PMID: 25988518 (View on PubMed)

Study Documents

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

AVO105948

Identifier Type: -

Identifier Source: org_study_id