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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00056407




Registration number
NCT00056407
Ethics application status
Date submitted
11/03/2003
Date registered
13/03/2003
Date last updated
23/09/2016

Titles & IDs
Public title
"REDUCE" - A Clinical Research Study To Reduce The Incidence Of Prostate Cancer In Men Who Are At Increased Risk
Scientific title
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of the Efficacy and Safety of Dutasteride 0.5 mg Administered Orally Once Daily for Four Years to Reduce the Risk of Biopsy-Detectable Prostate Cancer
Secondary ID [1] 0 0
ARI40006
Universal Trial Number (UTN)
Trial acronym
REDUCE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neoplasms, Prostate 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Dutasteride
Treatment: Drugs - Placebo

Placebo Comparator: Placebo Arm - Eligible subjects will complete a 4-week placebo run-in followed by randomization to matched placebo in a 1:1 ratio.

Experimental: dustasteride arm - Eligible subjects will complete a 4-week placebo run-in followed by randomization to 0.5mg dutasteride in a 1:1 ratio. Randomization will be stratified by center.


Treatment: Drugs: Dutasteride
After successful completion of the placebo run-in phase, subjects who continue to meet eligibility requirements will be randomized into the double-blind phase of the study and issued a 6-month supply of study drug. Subjects will self-administer study drug once daily dosing of 0.5mg of dutasteride orally for up to 4 years.

Treatment: Drugs: Placebo
After successful completion of the placebo run-in phase, subjects who continue to meet eligibility requirements will be randomized into the double-blind phase of the study and issued a 6-month supply of study drug. Subjects will self-administer study drug once daily orally for up to 4 years.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Crude Rate Approach)
Timepoint [1] 0 0
Years 1-2, Years 3-4, and Overall (Years 1-4)
Primary outcome [2] 0 0
Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Modified Crude Rate Approach)
Timepoint [2] 0 0
Years 1-2, Years 3-4, and Overall (Years 1-4)
Primary outcome [3] 0 0
Number of Participants With Biopsy-detectable Prostate Cancer at Years 2 and 4 (Restricted Crude Rate Approach)
Timepoint [3] 0 0
Years 1-2, Years 3-4, and Overall (Years 1-4)
Secondary outcome [1] 0 0
Number of Participants With the Indicated Gleason Score at Diagnosis
Timepoint [1] 0 0
Baseline to Year 4
Secondary outcome [2] 0 0
Number of Participants With HGPIN, ASAP, and Prostate Cancer at Biopsy
Timepoint [2] 0 0
Baseline to Year 4
Secondary outcome [3] 0 0
Volume of HGPIN at Biopsy
Timepoint [3] 0 0
Baseline to Year 4
Secondary outcome [4] 0 0
Percentage of Core Involved at Diagnosis
Timepoint [4] 0 0
Baseline to Year 4
Secondary outcome [5] 0 0
Number of Cancer-positive Cores
Timepoint [5] 0 0
Baseline to Year 4
Secondary outcome [6] 0 0
Treatment Alteration Score
Timepoint [6] 0 0
Baseline to Year 4
Secondary outcome [7] 0 0
Number of Participants Undergoing Intervention (Surgical and Non-surgical) for Prostate Cancer Treatment
Timepoint [7] 0 0
Baseline to Year 4
Secondary outcome [8] 0 0
Adjusted Mean Change From Baseline in the International Prostate Symptom Score (IPSS) at Month 48
Timepoint [8] 0 0
Baseline to Year 4 (Month 48)
Secondary outcome [9] 0 0
Adjusted Mean Percentage Change From Baseline in Prostate Volume at Months 24 and 48
Timepoint [9] 0 0
Baseline, Month 24, and Month 48
Secondary outcome [10] 0 0
Adjusted Mean Change From Baseline in Maximum Urinary Flow (Qmax) at Months 12, 24, 36, and 48
Timepoint [10] 0 0
Baseline and Months 12, 24, 36, and 48
Secondary outcome [11] 0 0
Number of Participants Starting Alpha Blockers to Control Benign Prostatic Hyperplasia (BPH) Symptoms
Timepoint [11] 0 0
Years 1-2, Overall (Years 1-4)
Secondary outcome [12] 0 0
Number of Participants With at Least One Event of Acute Urinary Retention (AUR)
Timepoint [12] 0 0
Years 1-2 and Overall (Years 1-4)
Secondary outcome [13] 0 0
Number of Participants With at Least One Urinary Tract Infection (UTI)
Timepoint [13] 0 0
Years 1-2, Years 3-4, and Overall (Years 1-4)
Secondary outcome [14] 0 0
Number of Participants With Post-biopsy Macroscopic Hematuria
Timepoint [14] 0 0
Baseline to Year 4
Secondary outcome [15] 0 0
Number of Participants With Post-biopsy Macroscopic Hematospermia
Timepoint [15] 0 0
Baseline through Year 4
Secondary outcome [16] 0 0
Overall Survival
Timepoint [16] 0 0
From time informed consent is signed to 4-month Safety Follow-Up period
Secondary outcome [17] 0 0
Adjusted Mean Change From Baseline in the Benign Prostatic Hypertrophy (BPH) Impact Index (BII) at Month 48
Timepoint [17] 0 0
Baseline and Month 48
Secondary outcome [18] 0 0
Adjusted Mean Change From Baseline in The Medical Outcomes Study Sleep Problems Index 6-item Standard Version (MOS Sleep-6S) at Month 48
Timepoint [18] 0 0
Baseline and Month 48
Secondary outcome [19] 0 0
Adjusted Mean Change From Baseline in the National Institutes of Health Chronic Prostatitis Symptom Index (NIH CPSI) at Month 48
Timepoint [19] 0 0
Baseline and Month 48
Secondary outcome [20] 0 0
Adjusted Mean Change From Baseline in Quality of Life Question 8 (QOL Q8) at Month 48
Timepoint [20] 0 0
Baseline and Month 48
Secondary outcome [21] 0 0
Adjusted Mean Change From Baseline in the Problem Assessment Scale of the Sexual Function Index (PASSFI) at Month 48
Timepoint [21] 0 0
Baseline and Month 48
Secondary outcome [22] 0 0
Number of Participants With the Indicated Serum Dihydrotestosterone (DHT) Concentration at Month 48
Timepoint [22] 0 0
Month 48
Secondary outcome [23] 0 0
Mean Change From Baseline in Testosterone at Month 48
Timepoint [23] 0 0
Baseline and Month 48

Eligibility
Key inclusion criteria
Inclusion criteria:

- Informed consent to participate in study.

- Have had a single negative prostate biopsy within 6 months prior to enrollment in
study.

- Have a PSA (prostate specific antigen) between 2.5 and 10 if 50-60 years of age; or a
PSA between 3.0 and 10 if over age 60.

- Ability and will to participate in study for 4 years.
Minimum age
50 Years
Maximum age
75 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

- More than one previous negative prostate biopsy.

- History of prostate cancer.

- Previous prostate surgery.

- Inability to urinate requiring the need of a catheter during the previous 2 years.

- Any condition (other than benign prostatic hypertrophy) which may result in urinary
symptoms or changes in urine flow rate.

- Cancer within previous 5 years (other than basal or squamous cell cancers of the
skin).

- Any unstable serious medical condition.

- Use within the past 12 months of finasteride (Proscar or Propecia), dutasteride
(Avodart), testosterone, or drugs that can block the action of male hormones.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2009
Sample size
Target
Accrual to date
Final
8231
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - Darlinghurst
Recruitment hospital [2] 0 0
GSK Investigational Site - Kogarah
Recruitment hospital [3] 0 0
GSK Investigational Site - Randwick
Recruitment hospital [4] 0 0
GSK Investigational Site - Westmead
Recruitment hospital [5] 0 0
GSK Investigational Site - Herston
Recruitment hospital [6] 0 0
GSK Investigational Site - Kippa Ring
Recruitment hospital [7] 0 0
GSK Investigational Site - Woolloongabba
Recruitment hospital [8] 0 0
GSK Investigational Site - Adelaide
Recruitment hospital [9] 0 0
GSK Investigational Site - Mentone
Recruitment hospital [10] 0 0
GSK Investigational Site - Parkville
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
2031 - Randwick
Recruitment postcode(s) [4] 0 0
2145 - Westmead
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4029 - Herston
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4021 - Kippa Ring
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4102 - Woolloongabba
Recruitment postcode(s) [8] 0 0
5000 - Adelaide
Recruitment postcode(s) [9] 0 0
3194 - Mentone
Recruitment postcode(s) [10] 0 0
3050 - Parkville
Recruitment outside Australia
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United States of America
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Alabama
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Alaska
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This 4-year study will compare how safe and effective an oral investigational medicine is
(compared to placebo) in preventing the development of prostate cancer in men that are
defined by the study entrance criteria as being at an increased risk for prostate cancer.
Study visits to the clinic will occur every 6 months for up to 4 years (10 clinic visits),
and a prostate biopsy will be performed at 2 and 4 years of treatment.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00056407
Trial related presentations / publications
Kader AK, Sun J, Reck BH, Newcombe PJ, Kim ST, Hsu FC, D'Agostino RB Jr, Tao S, Zhang Z, Turner AR, Platek GT, Spraggs CF, Whittaker JC, Lane BR, Isaacs WB, Meyers DA, Bleecker ER, Torti FM, Trent JM, McConnell JD, Zheng SL, Condreay LD, Rittmaster RS, Xu J. Potential impact of adding genetic markers to clinical parameters in predicting prostate biopsy outcomes in men following an initial negative biopsy: findings from the REDUCE trial. Eur Urol. 2012 Dec;62(6):953-61. doi: 10.1016/j.eururo.2012.05.006. Epub 2012 May 12.
Aubin SM, Reid J, Sarno MJ, Blase A, Aussie J, Rittenhouse H, Rittmaster R, Andriole GL, Groskopf J. PCA3 molecular urine test for predicting repeat prostate biopsy outcome in populations at risk: validation in the placebo arm of the dutasteride REDUCE trial. J Urol. 2010 Nov;184(5):1947-52. doi: 10.1016/j.juro.2010.06.098. Epub 2010 Sep 17.
Wu C, Moreira DM, Gerber L, Rittmaster RS, Andriole GL, Freedland SJ. Diabetes and prostate cancer risk in the REDUCE trial. Prostate Cancer Prostatic Dis. 2011 Dec;14(4):326-31. doi: 10.1038/pcan.2011.28. Epub 2011 Jun 28.
Roehrborn CG, Nickel JC, Andriole GL, Gagnier RP, Black L, Wilson TH, Rittmaster RS. Dutasteride improves outcomes of benign prostatic hyperplasia when evaluated for prostate cancer risk reduction: secondary analysis of the REduction by DUtasteride of prostate Cancer Events (REDUCE) trial. Urology. 2011 Sep;78(3):641-6. doi: 10.1016/j.urology.2011.03.063. Epub 2011 Jul 20.
Bostwick DG, Qian J, Drewnowska K, Varvel S, Bostwick KC, Marberger M, Rittmaster RS. Prostate needle biopsy quality in reduction by dutasteride of prostate cancer events study: worldwide comparison of improvement with investigator training and centralized laboratory processing. Urology. 2010 Jun;75(6):1406-10. doi: 10.1016/j.urology.2009.07.1348. Epub 2009 Nov 25.
Crawford ED, Andriole GL, Marberger M, Rittmaster RS. Reduction in the risk of prostate cancer: future directions after the Prostate Cancer Prevention Trial. Urology. 2010 Mar;75(3):502-9. doi: 10.1016/j.urology.2009.05.099. Epub 2009 Dec 29.
G Andriole, D Bostwick, O Brawley, L Gomella, M Marberger, F Montorsi, C Pettaway, T Tammela, C Teloken, D Tindall, M Somerville, I Fowler and R Rittmaster on behalf of the REDUCE Study Group. Risk reduction in men at increased risk: outcomes of the REduction by Dutasteride of prostate Cancer Events (REDUCE) trial. [N Engl J Med]. 2010;362(13):1192-202.
Andriole GL, Bostwick D, Brawley OW, Gomella L, Marberger M, Montorsi F, Pettaway C, Tammela TL, Teloken C, Tindall D, Freedland SJ, Somerville MC, Wilson TH, Fowler I, Castro R, Rittmaster RS; REDUCE Study Group. The effect of dutasteride on the usefulness of prostate specific antigen for the diagnosis of high grade and clinically relevant prostate cancer in men with a previous negative biopsy: results from the REDUCE study. J Urol. 2011 Jan;185(1):126-31. doi: 10.1016/j.juro.2010.09.011. Epub 2010 Nov 12.
Andriole GL, Bostwick DG, Brawley OW, Gomella LG, Marberger M, Montorsi F, Pettaway CA, Tammela TL, Teloken C, Tindall DJ, Somerville MC, Wilson TH, Fowler IL, Rittmaster RS; REDUCE Study Group. Effect of dutasteride on the risk of prostate cancer. N Engl J Med. 2010 Apr 1;362(13):1192-202. doi: 10.1056/NEJMoa0908127.
Nickel JC, Roehrborn C, Montorsi F, Wilson TH, Rittmaster RS. Dutasteride reduces prostatitis symptoms compared with placebo in men enrolled in the REDUCE study. J Urol. 2011 Oct;186(4):1313-8. doi: 10.1016/j.juro.2011.05.071. Epub 2011 Aug 17.
Jean-Alfred Thomas, II, Leah Gerber, Lionel Banez, Daniel Moreira,Ramiro Castro, Gerald L. Andriole and Stephen J. Freedland. Prostate Cancer Risk in Men with Prostate and Breast Cancer Family History: Results from the REDUCE study. [J Intern Med [Epub Dec 28 2011]]. 2011;
Marberger M, McConnell JD, Fowler I, Andriole GL, Bostwick DG, Somerville MC, Rittmaster RS. Biopsy misidentification identified by DNA profiling in a large multicenter trial. J Clin Oncol. 2011 May 1;29(13):1744-9. doi: 10.1200/JCO.2010.32.1646. Epub 2011 Mar 28.
Marberger M, Freedland SJ, Andriole GL, Emberton M, Pettaway C, Montorsi F, Teloken C, Rittmaster RS, Somerville MC, Castro R. Usefulness of prostate-specific antigen (PSA) rise as a marker of prostate cancer in men treated with dutasteride: lessons from the REDUCE study. BJU Int. 2012 Apr;109(8):1162-9. doi: 10.1111/j.1464-410X.2011.10373.x. Epub 2011 Jun 23.
Marberger M, Wilson TH, Rittmaster RS. Low serum testosterone levels are poor predictors of sexual dysfunction. BJU Int. 2011 Jul;108(2):256-62. doi: 10.1111/j.1464-410X.2010.09766.x. Epub 2010 Oct 18.
Kattan MW, Earnshaw SR, McDade CL, Black LK, Andriole GL. Cost effectiveness of chemoprevention for prostate cancer with dutasteride in a high-risk population based on results from the REDUCE clinical trial. Appl Health Econ Health Policy. 2011 Sep 1;9(5):305-15. doi: 10.2165/11592200-000000000-00000.
Muller RL, Gerber L, Moreira DM, Andriole G, Castro-Santamaria R, Freedland SJ. Serum testosterone and dihydrotestosterone and prostate cancer risk in the placebo arm of the Reduction by Dutasteride of Prostate Cancer Events trial. Eur Urol. 2012 Nov;62(5):757-64. doi: 10.1016/j.eururo.2012.05.025. Epub 2012 May 18.
Newcombe PJ, Reck BH, Sun J, Platek GT, Verzilli C, Kader AK, Kim ST, Hsu FC, Zhang Z, Zheng SL, Mooser VE, Condreay LD, Spraggs CF, Whittaker JC, Rittmaster RS, Xu J. A comparison of Bayesian and frequentist approaches to incorporating external information for the prediction of prostate cancer risk. Genet Epidemiol. 2012 Jan;36(1):71-83. doi: 10.1002/gepi.21600.
Aubin SM, Reid J, Sarno MJ, Blase A, Aussie J, Rittenhouse H, Rittmaster RS, Andriole GL, Groskopf J. Prostate cancer gene 3 score predicts prostate biopsy outcome in men receiving dutasteride for prevention of prostate cancer: results from the REDUCE trial. Urology. 2011 Aug;78(2):380-5. doi: 10.1016/j.urology.2011.03.033.
Stephen J. Freedland, Leah Gerber, Lionel Banez, Daniel Moreira, Gerald L. Andriole, and Roger S. Rittmaster on behalf of the REDUCE Study Group. Statin Use and the Risk of Prostate Cancer and High-grade Prostate Cancer: Results from the REDUCE study. [AUA 2011 Annual Meeting]. 2011;185(4 Suppl):e135.
Thomas JA 2nd, Gerber L, Banez LL, Moreira DM, Rittmaster RS, Andriole GL, Freedland SJ. Prostate cancer risk in men with baseline history of coronary artery disease: results from the REDUCE Study. Cancer Epidemiol Biomarkers Prev. 2012 Apr;21(4):576-81. doi: 10.1158/1055-9965.EPI-11-1017. Epub 2012 Feb 7.
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
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Country 0 0
Phone 0 0
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Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00056407