Last updated: 08/02/2019 17:40:47

The effect of dutasteride (0.5 mg/day) on prostate cancer risk reduction using three randomized controlled trials; A set of meta-analyses.

GSK study ID
116288
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: The effect of dutasteride (0.5 mg/day) on prostate cancer risk reduction using three randomized controlled trials; A set of meta-analyses.
Trial description: To evaluate the data from dutasteride randomized controlled clinical trials ≥ 2 years of duration together to examine the efficacy of using dutasteride for prostate cancer risk reduction
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Effect of Dutasteride (0.5mg daily) or Dutasteride (0.5mg daily) + Tamsulosin (0.4mg daily) vs. Placebo or Tamsulosin (0.4mg daily) on prostate cancer risk reduction on All cancers.

Timeframe: 4 years

Secondary outcomes:

Effect of Dutasteride (0.5mg daily) or Dutasteride (0.5mg daily) + Tamsulosin (0.4mg daily) vs. Placebo or Tamsulosin (0.4mg daily) on prostate cancer risk reduction on “For Cause” cancers.

Timeframe: 4 years

Effect of Dutasteride (0.5mg daily) or Dutasteride (0.5mg daily) + Tamsulosin (0.4mg daily) vs. Placebo or Tamsulosin (0.4mg daily) on risk reduction of Gleason Scores of 7-10 prostate cancers.

Timeframe: 4 years

Effect of Dutasteride (0.5mg daily) or Dutasteride (0.5mg daily) + Tamsulosin (0.4mg daily) vs. Placebo or Tamsulosin (0.4mg daily) on risk reduction of Gleason Scores of 8-10 prostate cancers.

Timeframe: 4 years

Interventions:
  • Drug: Dutasteride
    • Enrollment:
    0
    Primary completion date:
    2010-23-08
    Observational study model:
    Other
    Time perspective:
    Retrospective
    Clinical publications:
    Andriole G.L., Bostwick,D.G., Brawley,O.W., Gomella,L.G., Marberger,M., Montorsi,F., Pettaway,C.A., Tammela,T.L., Teloken,C., Tindall,D.J., Somerville,M.C., Wilson,T.H., Fowler,I.L., and Rittmaster,R.S. (2010). Effect of dutasteride on the risk of prostate cancer. N. Engl. J. Med. 362, 1192-1202.
    Andriole G.L., Roehrborn C., Schulman K.M., Slawin K.M., Somerville M., Rittmaster R.S. (2004). Effect of dutasteride on the detection of prostate cancer in men with benign prostatic hyperplasia. Urology 64, 537–43.
    Neerav Monga, Amyn Sayani, Daniel A. Rubinger, Timothy H. Wilson, Zhen Su. The effect of dutasteride on the detection of prostate cancer: A set of meta-analyses. Can Urol Assoc J. 2013;7:E161-E167.
    Roehrborn C.G., Andriole G.L., Wilson T.H., Castro R.C., Rittmaster R.S., (2011). Effect of Dutasteride on Prostate Biopsy Rates and the Diagnosis of Prostate Cancer in Men with Lower Urinary Tract Symptoms and Enlarged Prostates in the combination of Avodart and Tamsulosin Trial, Eur. Urol., 59, 244-249.
    Medical condition
    Neoplasms, Prostate
    Product
    dutasteride, dutasteride/tamsulosin, tamsulosin
    Collaborators
    Not applicable
    Study date(s)
    August 2010 to August 2010
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Male
    Age
    Not applicable
    Accepts healthy volunteers
    none
    • REDUCE inclusion criteria: Men were eligible for inclusion in the study if they were 50 to 75 years of age, had a prostate-specific antigen (PSA) level of 2.5 to 10.0 ng/ml, and had had one negative prostate biopsy (6 to 12 cores) within 6 months before enrolment.
    • ARIA3001, ARIA3002 and ARIB3003 inclusion criteria: men who were ≥ 50 years of age with a clinical diagnosis of BPH, International Prostate Symptom Score ≥ 12, prostate volume ≥ 30 cm3, prostate-specific antigen 1.5–10 ng/ml, and maximum urinary flow rate (Qmax) ≤ 15 ml/s with minimum voided volume ≥ 125 ml.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • REDUCE inclusion criteria: Men were eligible for inclusion in the study if they were 50 to 75 years of age, had a prostate-specific antigen (PSA) level of 2.5 to 10.0 ng/ml, and had had one negative prostate biopsy (6 to 12 cores) within 6 months before enrolment. ARIA3001, ARIA3002 and ARIB3003 inclusion criteria: men who were ≥ 50 years of age with a clinical diagnosis of BPH, International Prostate Symptom Score ≥ 12, prostate volume ≥ 30 cm3, prostate-specific antigen 1.5–10 ng/ml, and maximum urinary flow rate (Qmax) ≤ 15 ml/s with minimum voided volume ≥ 125 ml. CombAT inclusion criteria: men, ≥ 50 years of age with a clinical diagnosis of BPH, International Prostate Symptom Score ≥ 12, prostate volume ≥ 30 cm3, prostate-specific antigen 1.5–10 ng/ml, and maximum urinary flow rate (Qmax) > 5 and ≤ 15 ml/s with minimum voided volume ≥ 125 ml.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    2010-23-08
    Actual study completion date
    2010-23-08

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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