Assessment Of Dutasteride (AVODART) In Extending The Time To Progression Of Low-Risk, Localized Prostate Cancer In Men
A Randomized, Double-Blind, Placebo-Controlled Trial Assessing the Efficacy and Safety of Dutasteride in Extending the Time to Progression of Low-Risk, Localized Prostate Cancer in Men Who Are Candidates for or Undergoing Expectant Management
1 other identifier
interventional
302
2 countries
82
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jul 2006
Longer than P75 for phase_4
82 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2006
CompletedFirst Submitted
Initial submission to the registry
August 11, 2006
CompletedFirst Posted
Study publicly available on registry
August 15, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedResults Posted
Study results publicly available
June 14, 2011
CompletedJanuary 18, 2017
November 1, 2016
3.7 years
August 11, 2006
March 31, 2011
November 30, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Prostate Cancer (PCa) Progression [Restricted Crude Rate Analysis: Number of Participants With PCa Divided by Number of Participants in the Intent-to-Treat (ITT) Population Who Had >=1 Post-baseline Biopsy or Had a Progression
PC progression (prog.) was defined as the earliest occurrence of primary therapy, also referred to as therapeutic prog., for PC (prostatectomy/radiation/hormonal therapy); or pathological prog., defined as 1 of the following: \>=4 cores involved; \>=50% of any 1 core involved; or a Gleason pattern of \>=4 as a result of any on-study/for-cause biopsy. Primary Gleason grade is assigned to the most common tumor pattern; a second grade to the next most common tumor pattern. The two grades are added together to get a score. Gleason grade= 1-5; Gleason score=2-10; 5 and 10 indicate worst prognosis.
Year 1.5 and Overall (Years 0-3)
Secondary Outcomes (29)
Number of Participants With Therapeutic Progression
Year 1.5 and Overall (Years 0-3)
Number of Participants With Pathologic Progression
Year 1.5 and Overall (Years 0-3)
Participants With at Least One Post-baseline Biopsy With the Indicated Prostate Cancer (PCa) Diagnosis
Baseline to Month 18
Participants With at Least One Post-baseline Biopsy With the Indicated Prostate Cancer (PCa) Diagnosis for Their Final Biopsy
Years 0-3
Number of Cancer-positive Cores in a 12-core Biopsy
Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)
- +24 more secondary outcomes
Study Arms (2)
Dutasteride
ACTIVE COMPARATORDutasteride 0.5mg
Placebo
PLACEBO COMPARATORMatching placebo
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (82)
GSK Investigational Site
Little Rock, Arkansas, 72211, United States
GSK Investigational Site
Beverly Hills, California, 90210, United States
GSK Investigational Site
Laguna Hills, California, 92653, United States
GSK Investigational Site
Mission Hills, California, 91345, United States
GSK Investigational Site
Modesto, California, 95350, United States
GSK Investigational Site
San Bernardino, California, 92404, United States
GSK Investigational Site
Torrance, California, 90506, United States
GSK Investigational Site
Englewood, Colorado, 80113, United States
GSK Investigational Site
Wheat Ridge, Colorado, 80033, United States
GSK Investigational Site
New Britain, Connecticut, 06052, United States
GSK Investigational Site
Trumbull, Connecticut, 06611, United States
GSK Investigational Site
Washington D.C., District of Columbia, 20307, United States
GSK Investigational Site
Jacksonville, Florida, 32224, United States
GSK Investigational Site
Largo, Florida, 33773, United States
GSK Investigational Site
Orlando, Florida, 32803, United States
GSK Investigational Site
Roswell, Georgia, 30076, United States
GSK Investigational Site
Coeur d'Alene, Idaho, 83814, United States
GSK Investigational Site
Chicago, Illinois, 60612, United States
GSK Investigational Site
Melrose Park, Illinois, 60160, United States
GSK Investigational Site
Fort Wayne, Indiana, 46825, United States
GSK Investigational Site
Newburgh, Indiana, 47630, United States
GSK Investigational Site
Overland Park, Kansas, 66211, United States
GSK Investigational Site
Shreveport, Louisiana, 71106, United States
GSK Investigational Site
Annapolis, Maryland, 21401, United States
GSK Investigational Site
Greenbelt, Maryland, 20770, United States
GSK Investigational Site
Watertown, Massachusetts, 02472, United States
GSK Investigational Site
Minneapolis, Minnesota, United States
GSK Investigational Site
Saint Cloud, Minnesota, 56303, United States
GSK Investigational Site
Jackson, Mississippi, 39202, United States
GSK Investigational Site
St Louis, Missouri, 63136, United States
GSK Investigational Site
Las Vegas, Nevada, 89148, United States
GSK Investigational Site
Marlton, New Jersey, 08053, United States
GSK Investigational Site
Albuquerque, New Mexico, 87109, United States
GSK Investigational Site
Albany, New York, 12208, United States
GSK Investigational Site
Elmont, New York, 11003, United States
GSK Investigational Site
Garden City, New York, 11530, United States
GSK Investigational Site
New York, New York, 10016, United States
GSK Investigational Site
Orchard Park, New York, 14127, United States
GSK Investigational Site
Syracuse, New York, 13210, United States
GSK Investigational Site
Greensboro, North Carolina, 27403, United States
GSK Investigational Site
Salisbury, North Carolina, 28144, United States
GSK Investigational Site
Winston-Salem, North Carolina, 27103, United States
GSK Investigational Site
Columbus, Ohio, 43214, United States
GSK Investigational Site
Springfield, Oregon, 97477, United States
GSK Investigational Site
Bala-Cynwyd, Pennsylvania, 19004, United States
GSK Investigational Site
Lancaster, Pennsylvania, 17604, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19107, United States
GSK Investigational Site
Memphis, Tennessee, 38119, United States
GSK Investigational Site
Nashville, Tennessee, 37232, United States
GSK Investigational Site
San Antonio, Texas, 78229, United States
GSK Investigational Site
Temple, Texas, 76508, United States
GSK Investigational Site
Salt Lake City, Utah, 84107, United States
GSK Investigational Site
Richmond, Virginia, 23235, United States
GSK Investigational Site
Virginia Beach, Virginia, 23455, United States
GSK Investigational Site
Williamsburg, Virginia, 23185, United States
GSK Investigational Site
Seattle, Washington, 98101, United States
GSK Investigational Site
Seattle, Washington, 98166, United States
GSK Investigational Site
Spokane, Washington, 99202, United States
GSK Investigational Site
Surrey, British Columbia, V3V 1N1, Canada
GSK Investigational Site
Victoria, British Columbia, V8T 5G1, Canada
GSK Investigational Site
Victoria, British Columbia, V8V 3N1, Canada
GSK Investigational Site
Fredericton, New Brunswick, E3B 5B8, Canada
GSK Investigational Site
Barrie, Ontario, L4M 7G1, Canada
GSK Investigational Site
Brampton, Ontario, L6T 3J1, Canada
GSK Investigational Site
Brantford, Ontario, N3R 4N3, Canada
GSK Investigational Site
Burlington, Ontario, L7N 3V2, Canada
GSK Investigational Site
Burlington, Ontario, L7S 1V2, Canada
GSK Investigational Site
Guelph, Ontario, N1H 5J1, Canada
GSK Investigational Site
Kitchener, Ontario, N2N 2B9, Canada
GSK Investigational Site
North Bay, Ontario, P1B 4Z2, Canada
GSK Investigational Site
Oakville, Ontario, L6H 3P1, Canada
GSK Investigational Site
Scarborough Village, Ontario, M1P 2T7, Canada
GSK Investigational Site
Toronto, Ontario, M4C 5T2, Canada
GSK Investigational Site
Toronto, Ontario, M5G 2M9, Canada
GSK Investigational Site
Toronto, Ontario, M6A 3B5, Canada
GSK Investigational Site
Chicoutimi, Quebec, G7H 4A3, Canada
GSK Investigational Site
Greenfield Park, Quebec, J4V 2H3, Canada
GSK Investigational Site
Laval, Quebec, H7G 2E6, Canada
GSK Investigational Site
Montreal, Quebec, H3G 1A4, Canada
GSK Investigational Site
Pointe-Claire, Quebec, H9R 4S3, Canada
GSK Investigational Site
Québec, Quebec, G1R 2J6, Canada
GSK Investigational Site
Trois-Rivières, Quebec, G9A 3V7, Canada
Related Publications (2)
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.
PMID: 22277570BACKGROUNDMoreira 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.
PMID: 25988518DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2006
First Posted
August 15, 2006
Study Start
July 1, 2006
Primary Completion
March 1, 2010
Study Completion
July 1, 2010
Last Updated
January 18, 2017
Results First Posted
June 14, 2011
Record last verified: 2016-11
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.