Last updated: 11/04/2018 05:21:40
Assessment Of Dutasteride (AVODART) In Extending The Time To Progression Of Low-Risk, Localized Prostate Cancer In Men
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: 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
Trial description: 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).
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
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
Timeframe: Year 1.5 and Overall (Years 0-3)
Secondary outcomes:
Number of participants with therapeutic progression
Timeframe: Year 1.5 and Overall (Years 0-3)
Number of participants with pathologic progression
Timeframe: Year 1.5 and Overall (Years 0-3)
Participants with at least one post-baseline biopsy with the indicated prostate cancer (PCa) diagnosis
Timeframe: Baseline to Month 18
Participants with at least one post-baseline biopsy with the indicated prostate cancer (PCa) diagnosis for their final biopsy
Timeframe: Years 0-3
Number of cancer-positive cores in a 12-core biopsy
Timeframe: Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)
Change from baseline in the number of cancer-positive cores in a 12-core biopsy at Years 1.5, 3, and 0-3
Timeframe: Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)
Mean percentage of cancer-positive cores in a 12-core biopsy
Timeframe: Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)
Change from baseline in the percentage of cancer-positive cores in a 12-core biopsy at Years 1.5, 3, and 0-3
Timeframe: Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)
Cumulative length of cancer tumor core
Timeframe: Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)
Change from baseline in the cumulative length of cancer tumor core at Years 1.5, 3, and 0-3
Timeframe: Baseline, Year 1.5, Year 3, Years 0-3 (Final biopsy)
Number of participants with the indicated change from baseline in Gleason score (GS) on repeat biopsy at Year 1.5
Timeframe: Year 1.5
Number of participants with the indicated change from baseline in Gleason score on repeat biopsy at Years 0-3
Timeframe: Years 0-3 (Final Biopsy)
Number of participants with the indicated total Gleason score
Timeframe: Years 0-3 (Final Biopsy)
Number of biopsies with the indicated clinical Tumor Stage at Baseline
Timeframe: Baseline
Number of post-baseline biopsies with the indicated change from Baseline in clinical stage
Timeframe: Months 0-18
Prostate volume (PV) LOCF
Timeframe: Baseline and Years 1.5 and 3
Change from baseline in prostate volume at Years 1.5 and 3
Timeframe: Baseline and Years 1.5 and 3
Percent change from baseline in prostate volume at Years 1.5 and 3
Timeframe: Baseline and Years 1.5 and 3
Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC)
Timeframe: Baseline and Month 3, 6, 12, 18, and 36
Change from baseline in Total Memorial Anxiety Scale Scores for Prostate Cancer (MAX-PC) LOCF
Timeframe: Baseline and Months 3, 6, 12, 18, and 36
Total MAX-PC Anxiety Subscale Score related to PSA testing
Timeframe: Baseline and Months 3, 6, 12, 18, and 36
Change from Baseline in MAX-PC Anxiety Subscale Score related to PSA testing (LOCF)
Timeframe: Baseline and Months 3, 6, 12, 18, and 36
Total MAX-PC Fear of Recurrence Subscale Score
Timeframe: Baseline and Months 3, 6, 12, 18, and 36
Change from Baseline in MAX-PC Fear of Recurrence Subscale Score (LOCF)
Timeframe: Baseline and Months 3, 6, 12, 18, and 36
Total Functional Assessment of Cancer Therapy Scale, Prostate Module (FACT-P) Score
Timeframe: Baseline and Months 18 and 36
Change from Baseline in Total FACT-P Score (LOCF)
Timeframe: Baseline and Months 18 and 36
Percent change from Baseline in Total FACT-P Score (LOCF)
Timeframe: Baseline and Months 18 and 36
Change from Baseline in FACT-P Physical Well-Being Subscale Score (LOCF)
Timeframe: Baseline and Months 18 and 36
Change from Baseline in FACT-P Social Well-Being Subscale Score (LOCF)
Timeframe: Baseline and Months 18 and 36
Interventions:
Enrollment:
302
Primary completion date:
2010-20-07
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Fleshner N, Lucia S, Eure G, Aaron L, Egerdie B, Nandy I, Black L, Rittmaster R. Dutasteride in localised prostate cancer management: the REDEEM randomised, double-blind, placebo-controlled trial. [Lancet]. 2012;379(9821):1103-1111.
Medical condition
Neoplasms, Prostate
Product
dutasteride
Collaborators
GSK
Study date(s)
July 2006 to July 2010
Type
Interventional
Phase
4
Participation criteria
Sex
Male
Age
50 - 80 years
Accepts healthy volunteers
No
- 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.
- Subject has ever been treated for prostate cancer with any of the following:
- Radiotherapy (external beam or brachytherapy)
Inclusion and exclusion 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.
Trial location(s)
Location
GSK Investigational Site
Beverly Hills, California, United States, 90210
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Bala Cynwyd, Pennsylvania, United States, 19004
Status
Study Complete
Location
GSK Investigational Site
Laguna Hills, California, United States, 92653
Status
Study Complete
Location
GSK Investigational Site
Torrance, California, United States, 90506
Status
Study Complete
Location
GSK Investigational Site
Victoria, British Columbia, Canada, V8V 3N1
Status
Study Complete
Location
GSK Investigational Site
Watertown, Massachusetts, United States, 02472
Status
Study Complete
Location
GSK Investigational Site
Chicago, Illinois, United States, 60612
Status
Study Complete
Location
GSK Investigational Site
Little Rock, Arkansas, United States, 72211
Status
Study Complete
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63136
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Study Complete
Location
GSK Investigational Site
Albuquerque, New Mexico, United States, 87109
Status
Study Complete
Location
GSK Investigational Site
Englewood, Colorado, United States, 80113
Status
Study Complete
Location
GSK Investigational Site
Mission Hills, California, United States, 91345
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Wheat Ridge, Colorado, United States, 80033
Status
Study Complete
Location
GSK Investigational Site
Springfield, Oregon, United States, 97477
Status
Study Complete
Location
GSK Investigational Site
Salt Lake City, Utah, United States, 84107
Status
Study Complete
Location
GSK Investigational Site
New York, New York, United States, 10016
Status
Study Complete
Location
GSK Investigational Site
Orchard Park, New York, United States, 14127
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Spokane, Washington, United States, 99202
Status
Study Complete
Location
GSK Investigational Site
Williamsburg, Virginia, United States, 23185
Status
Study Complete
Location
GSK Investigational Site
Brampton, Ontario, Canada, L6T 3J1
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Richmond, Virginia, United States, 23235
Status
Study Complete
Location
GSK Investigational Site
Modesto, California, United States, 95350
Status
Study Complete
Location
GSK Investigational Site
Trumbull, Connecticut, United States, 06611
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Memphis, Tennessee, United States, 38119
Status
Study Complete
Location
GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19107
Status
Study Complete
Location
GSK Investigational Site
Annapolis, Maryland, United States, 21401
Status
Study Complete
Location
GSK Investigational Site
Garden City, New York, United States, 11530
Status
Study Complete
Location
GSK Investigational Site
Virginia Beach, Virginia, United States, 23455
Status
Study Complete
Location
GSK Investigational Site
Elmont, New York, United States, 11003
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Pointe-Claire, Québec, Canada, H9R 4S3
Status
Study Complete
Location
GSK Investigational Site
Orlando, Florida, United States, 32803
Status
Study Complete
Location
GSK Investigational Site
Coeur D'Alene, Idaho, United States, 83814
Status
Study Complete
Location
GSK Investigational Site
Seattle, Washington, United States, 98101
Status
Study Complete
Location
GSK Investigational Site
Jackson, Mississippi, United States, 39202
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Trois Rivieres, Québec, Canada, G9A 3V7
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Columbus, Ohio, United States, 43214
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Victoria, British Columbia, Canada, V8T 5G1
Status
Study Complete
Location
GSK Investigational Site
Greensboro, North Carolina, United States, 27403
Status
Study Complete
Location
GSK Investigational Site
Largo, Florida, United States, 33773
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Overland Park, Kansas, United States, 66211
Status
Study Complete
Location
GSK Investigational Site
Syracuse, New York, United States, 13210
Status
Study Complete
Location
GSK Investigational Site
Roswell, Georgia, United States, 30076
Status
Study Complete
Location
GSK Investigational Site
Salisbury, North Carolina, United States, 28144
Status
Study Complete
Location
GSK Investigational Site
Newburgh, Indiana, United States, 47630
Status
Study Complete
Location
GSK Investigational Site
Shreveport, Louisiana, United States, 71106
Status
Study Complete
Location
GSK Investigational Site
Marlton, New Jersey, United States, 08053
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Seattle, Washington, United States, 98166
Status
Study Complete
Location
GSK Investigational Site
New Britain, Connecticut, United States, 06052
Status
Study Complete
Location
GSK Investigational Site
Nashville, Tennessee, United States, 37232
Status
Study Complete
Location
GSK Investigational Site
Greenbelt, Maryland, United States, 20770
Status
Study Complete
Location
GSK Investigational Site
Albany, New York, United States, 12208
Status
Study Complete
Location
GSK Investigational Site
Greenfield Park, Québec, Canada, J4V 2H3
Status
Study Complete
Location
GSK Investigational Site
Fredericton, New Brunswick, Canada, E3B 5B8
Status
Study Complete
Location
GSK Investigational Site
St. Cloud, Minnesota, United States, 56303
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Lancaster, Pennsylvania, United States, 17604
Status
Study Complete
Location
GSK Investigational Site
Melrose Park, Illinois, United States, 60160
Status
Terminated/Withdrawn
Location
GSK Investigational Site
North Bay, Ontario, Canada, P1B 4Z2
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Winston-Salem, North Carolina, United States, 27103
Status
Study Complete
Location
GSK Investigational Site
Jacksonville, Florida, United States, 32224
Status
Study Complete
Location
GSK Investigational Site
San Bernardino, California, United States, 92404
Status
Study Complete
Location
GSK Investigational Site
Surrey, British Columbia, Canada, V3V 1N1
Status
Study Complete
Location
GSK Investigational Site
Fort Wayne, Indiana, United States, 46825
Status
Study Complete
Location
GSK Investigational Site
Temple, Texas, United States, 76508
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Las Vegas, Nevada, United States, 89148
Status
Study Complete
Location
GSK Investigational Site
Washington, District of Columbia, United States, 20307
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2010-20-07
Actual study completion date
2010-20-07
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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