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.
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
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
Observational study model:
Other
Primary completion date:
2010-23-08
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)
No location data available.
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
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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