Neoplasms, ProstateNCT01337258
Economic Analyses of the REDUCE Trial
An observational study of Neoplasms, Prostate and Benign Prostatic Hyperplasia, run by GlaxoSmithKline.
Trial summary
The objective of this project is to conduct a retrospective economic analysis of the use of dutasteride for the prevention of prostate cancer based on data from the REDUCE clinical trial. Read more about this study
- Who is it for?
- Ages 50 to 75 years, men only
- Conditions the study is for
- Neoplasms, Prostate, Benign Prostatic Hyperplasia, Cancer
- What is being tested?
- Dutasteride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Jul 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Men at increase risk for prostate cancer ages 50-75 who were enrolled in the REDUCE study
Who may be able to join
- Men aged 50 to 75 years
- serum prostate-specific antigen (PSA) ≥2.5 ng per milliliter and ≤10 ng per milliliter (men aged 50-60 years) or ≥3.0 ng per milliliter and ≤10 ng per milliliter (men aged >60 years)
- single, negative prostate biopsy (6-12 cores) within 6 months prior to enrollment (independent of the study)
Who cannot join
- Principal exclusion criteria were more than one prior prostate biopsy
- high-grade intraepithelial neoplasia (HG-PIN) or atypical small acinar proliferation (ASAP) on the pre-entry prostate biopsy
- a prostate volume >80 ml, previous prostate surgery
- International Prostate Symptom Score (IPSS) ≥25 or ≥20 if already on alpha-blocker therapy for BPH
About this study
Official title: Economic Analyses Alongside the REDUCE Clinical Trial
The objective of this project is to conduct a retrospective economic analysis of the use of dutasteride for the prevention of prostate cancer based on data from the REDUCE clinical trial. REDUCE is a 4-year, phase 3, randomized, double-blind, parallel assignment clinical trial of the use of dutasteride compared with no chemopreventive treatment.
The REDUCE trial was a four-year, international, multicenter, randomized, double-blind, placebo-controlled, parallel group study. There were 790 investigators in 42 countries.
- Conditions
- Neoplasms, Prostate, Benign Prostatic Hyperplasia, Cancer
- Being tested
- Dutasteride, Placebo
- Keywords
- cost effectiveness, dutasteride, elevated risk population, Prostate cancer, prevention
- Medical subject headings
- Prostatic Neoplasms, Prostatic Hyperplasia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DutasterideDrug
Also called Placebo
dutasteride 0.5mg daily.
PlaceboDrug
Men taking placebo daily
| Study group | Role | What they receive |
|---|---|---|
| Men at increased risk for Prostate Cancer (PCA) | Not described Receives: Drug: Dutasteride; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost of treating prostate-related events
Prostate Related Events include Benign Prostatic Hyperplasia (BPH), Prostate Cancer (PCA) and Prostatitis
Measured: REDUCE clinical trial, 4 year time period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2011 (estimated)
- Study startJan 2010
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasms, ProstateStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01337258
- Sponsor's protocol ID
- 113979
- Status last verified
- May 2017
- First submitted
- 4 Mar 2010
- Last updated
- 30 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Economic Analyses Alongside the REDUCE Clinical Trial
- ClinicalTrials.gov ID
- NCT01337258
- Acronym / sponsor ID
- 113979
- Conditions
- Neoplasms, Prostate, Benign Prostatic Hyperplasia, Cancer
- Keywords
- cost effectiveness, dutasteride, elevated risk population, Prostate cancer, prevention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 18 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this project is to conduct a retrospective economic analysis of the use of dutasteride for the prevention of prostate cancer based on data from the REDUCE clinical trial. REDUCE is a 4-year, phase 3, randomized, double-blind, parallel assignment clinical trial of the use of dutasteride compared with no chemopreventive treatment.
The REDUCE trial was a four-year, international, multicenter, randomized, double-blind, placebo-controlled, parallel group study. There were 790 investigators in 42 countries.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Men at increased risk for Prostate Cancer (PCA) | – | Drug: Dutasteride, Drug: Placebo |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men at increase risk for prostate cancer ages 50-75 who were enrolled in the REDUCE study
Key inclusion criteria (3 listed)
- Men aged 50 to 75 years
- serum prostate-specific antigen (PSA) ≥2.5 ng per milliliter and ≤10 ng per milliliter (men aged 50-60 years) or ≥3.0 ng per milliliter and ≤10 ng per milliliter (men aged >60 years)
- single, negative prostate biopsy (6-12 cores) within 6 months prior to enrollment (independent of the study)
Key exclusion criteria (4 listed)
- Principal exclusion criteria were more than one prior prostate biopsy
- high-grade intraepithelial neoplasia (HG-PIN) or atypical small acinar proliferation (ASAP) on the pre-entry prostate biopsy
- a prostate volume >80 ml, previous prostate surgery
- International Prostate Symptom Score (IPSS) ≥25 or ≥20 if already on alpha-blocker therapy for BPH
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DutasterideAlso: Placebodutasteride 0.5mg daily. | Drug | Men at increased risk for Prostate Cancer (PCA) |
| PlaceboMen taking placebo daily | Drug | Men at increased risk for Prostate Cancer (PCA) |
Primary outcome
Cost of treating prostate-related events
Time frame: REDUCE clinical trial, 4 year time period
Prostate Related Events include Benign Prostatic Hyperplasia (BPH), Prostate Cancer (PCA) and Prostatitis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasms, Prostate and Benign Prostatic Hyperplasia, run by GlaxoSmithKline.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cost of treating prostate-related events (time frame: REDUCE clinical trial, 4 year time period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2017.