Prostate CancerNCT01529086
For Cause Prostate Biopsy in REDUCE Population Trial
An observational study of Prostate Cancer, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The REDUCE trial was conducted to determine whether dutasteride reduces the risk of incident prostate cancer, as detected on biopsy, among men who are at increased risk for the disease. Dutasteride was compared with placebo for 4 years period. Read more about this study
- Who is it for?
- Ages 50 to 75 years, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 6,608 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Feb 2012
- 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: REDUCE trial participants
Who may be able to join
- Group 1-subjects in the dutasteride treatment group who meet the following sets of criteria:
- A rise in PSA from nadir at any time post-nadir
- PSA change from baseline >0.2 ng/ml at any time post-baseline
- Abnormal DRE at any time post-baseline
- Free PSA<12% at any time post-baseline
- At least one of the above 4 criteria.
Show all 15Show fewer
- Group 2-subjects in the placebo treatment group who meet the following sets of criteria:
- Change from baseline PSA between 0.0 and 0.35 (ie, 0.0 ≤ change from baseline PSA < 0.35) at any time post-baseline. Note that in REDUCE PSA was recorded to the nearest 0.1.
- Abnormal DRE at any time post-baseline
- Change from baseline PSA ≥ 0.35 at any time post-baseline
- Change from baseline PSA ≥ 0.75 at any time post-baseline
- PSA ≥ 2.5 at any time post-baseline
- PSA ≥ 4.0 at any time post-baseline
- Percent Free PSA < 12% at any time post-baseline
- At least one of the above 7 criteria.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determining the Likelihood of Prostate Cancer Detection in Men Taking Dutasteride When Biopsy is Performed 'for Cause'.
The REDUCE trial was conducted to determine whether dutasteride reduces the risk of incident prostate cancer, as detected on biopsy, among men who are at increased risk for the disease. Dutasteride was compared with placebo for 4 years period. Results showed a relative risk reduction of 22.8 % (95% CI: 15.2 to 29.8)in prostate cancer.
For REDUCE, biopsies were defined as "protocol biopsy" if performed at certain timeframes, and "for cause" if outside these predetermined timeframes.
Read more
The investigators propose a post hoc analysis that would allow them to include biopsies that really justified a clinical indication, but were excluded from "for cause" analysis based on occurring at either the 2 or 4 year timeframes.
Thus the investigators propose analysis of both REDUCE groups by every yearly timeframe as:
Group 1--dutasteride group biopsied "for cause" using several definitions: biopsy of patients who received dutasteride whose PSA rose from nadir as defined in your own protocol,who had a PSA rise>0.2 ng/ml or who had a new abnormal DRE or had a free PSA<12% . The investigators define these as such because this would reasonably instigate biopsy if the clinician had a patient with this scenario in the non-study setting.
Group 2--placebo group biopsied "for cause" using several definitions, regardless of timeframe but reported at each year of the study and aggregate, with the aggregate number being the primary outcome. Thus the investigators would request results of biopsy of patients who received placebo To establish differences in biopsy positive rates the groups as per each definition listed, to determine if dutasteride decreased the likelihood of "for cause" biopsy compared to "not for cause" biopsy, and if there is a difference in cancer detection risk rate depending on cause vs. no cause in that group compared to placebo.
Read the detailed description
Purpose: Determining the likelihood of prostate cancer detection in men taking dutasteride when biopsy is performed 'for cause'.
Population: The population of interest is the REDUCE Biopsied population, that is, all subjects in the Efficacy population who have at least one post-baseline biopsy reviewed by the Central Pathology Laboratory.
Analyses: Initial interest will be focused on data from the Year 1-2 time period, to avoid the potential effect of the cancer diagnoses from the Year 2 scheduled biopsies on the assessments utilized in the "for cause" definitions. Only PSA data from Years 1-2 and baseline will be utilized in the computation of the various PSA metrics, and only Central Pathology results from Years 1-2 will be utilized to establish post-baseline diagnoses. PSA values on or within 42 days after date of biopsy will be excluded from the analyses, to avoid potential effects of biopsy on the PSA value.
For each of the 2 groups of subjects, the following will be summarized: number of subjects meeting the corresponding criteria, number and % of subjects diagnosed with prostate cancer, number and % of such subjects diagnosed with Gleason 7-10, and number and % of subjects diagnosed with either prostate cancer, HGPIN or ASAP. Summaries of the numbers of subjects meeting each of the specific criteria for group 1 (a through e) and Group 2 (a through h) will be provided.
In addition, summaries investigating the effect of baseline variables (such as age, family history of prostate cancer, prostate volume, percent free PSA, number of cores at the entry biopsy) on the occurrence of prostate cancer diagnoses and Gleason 7-10 diagnoses may be developed.
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, dutasteride, for cause prostate biopsy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Subjects on Dutasteride that meet the following criteria: 1. . A rise in PSA from nadir at any time post-nadir 2. . PSA change from baselin >0.2 mg/ml at any time post-baseline 3. . Abnormal DRE at any time post-baseline 4. . Free-PSA <12% at any time post-baseline 5. . At least one of the above 4 criteria 6. Subjects on Dutasteride that do not meet the above criteria | |
| Group 2 | Subjects on placebo treatment that meet the following criteria: 1. Change from baseline PSA between 0.0 and 0.35 (ie, 0.0 ≤ change from baseline PSA < 0.35) at any time post-baseline. Note that in REDUCE PSA was recorded to the nearest 0.1. 2. Abnormal DRE at any time post-baseline 3. Change from baseline PSA ≥ 0.35 at any time post-baseline 4. Change from baseline PSA ≥ 0.75 at any time post-baseline 5. PSA ≥ 2.5 at any time post-baseline 6. PSA ≥ 4.0 at any time post-baseline 7. Percent Free PSA < 12% at any time post-baseline 8. At least one of the above 7 criteria. 9. Subjects on placebo that do not meet the above criteria |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cancer detection risk among the groups in the "for cause" context
Determination of differences in cancer detection risk rate depending on cause vs no cause in that group compared to placebo
Measured: 4 years
Secondary outcomes (1)
Dutasteride as a key factor in the likelihood of "for cause" biopsy
Determination of dutasteride as an item in decreasing the likelihood of "for cause" biopsy compared to "not for cause" biopsy
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- 6,608 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Principal investigator, Stephen Jones, The Cleveland Clinic
- Investigators
- Stephen Jones, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01529086
- Sponsor's protocol ID
- REDUCE-FOR CAUSE
- Other IDs
- 115686
- Status last verified
- Aug 2016
- First submitted
- 31 Jan 2012
- Last updated
- 23 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 20357281
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Likelihood of Prostate Cancer Detection in Men Taking Dutasteride When Biopsy is Performed 'for Cause'.
- ClinicalTrials.gov ID
- NCT01529086
- Acronym / sponsor ID
- REDUCE-FOR CAUSE
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, dutasteride, for cause prostate biopsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,608 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Feb 2012
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 8 Feb 2012 (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 REDUCE trial was conducted to determine whether dutasteride reduces the risk of incident prostate cancer, as detected on biopsy, among men who are at increased risk for the disease. Dutasteride was compared with placebo for 4 years period. Results showed a relative risk reduction of 22.8 % (95% CI: 15.2 to 29.8)in prostate cancer.
For REDUCE, biopsies were defined as "protocol biopsy" if performed at certain timeframes, and "for cause" if outside these predetermined timeframes.
The investigators propose a post hoc analysis that would allow them to include biopsies that really justified a clinical indication, but were excluded from "for cause" analysis based on occurring at either the 2 or 4 year timeframes.
Thus the investigators propose analysis of both REDUCE groups by every yearly timeframe as:
Group 1--dutasteride group biopsied "for cause" using several definitions: biopsy of patients who received dutasteride whose PSA rose from nadir as defined in your own protocol,who had a PSA rise>0.2 ng/ml or who had a new abnormal DRE or had a free PSA<12% . The investigators define these as such because this would reasonably instigate biopsy if the clinician had a patient with this scenario in the non-study setting.
Group 2--placebo group biopsied "for cause" using several definitions, regardless of timeframe but reported at each year of the study and aggregate, with the aggregate number being the primary outcome. Thus the investigators would request results of biopsy of patients who received placebo To establish differences in biopsy positive rates the groups as per each definition listed, to determine if dutasteride decreased the likelihood of "for cause" biopsy compared to "not for cause" biopsy, and if there is a difference in cancer detection risk rate depending on cause vs. no cause in that group compared to placebo.
Detailed description
Purpose: Determining the likelihood of prostate cancer detection in men taking dutasteride when biopsy is performed 'for cause'.
Population: The population of interest is the REDUCE Biopsied population, that is, all subjects in the Efficacy population who have at least one post-baseline biopsy reviewed by the Central Pathology Laboratory.
Analyses: Initial interest will be focused on data from the Year 1-2 time period, to avoid the potential effect of the cancer diagnoses from the Year 2 scheduled biopsies on the assessments utilized in the "for cause" definitions. Only PSA data from Years 1-2 and baseline will be utilized in the computation of the various PSA metrics, and only Central Pathology results from Years 1-2 will be utilized to establish post-baseline diagnoses. PSA values on or within 42 days after date of biopsy will be excluded from the analyses, to avoid potential effects of biopsy on the PSA value.
For each of the 2 groups of subjects, the following will be summarized: number of subjects meeting the corresponding criteria, number and % of subjects diagnosed with prostate cancer, number and % of such subjects diagnosed with Gleason 7-10, and number and % of subjects diagnosed with either prostate cancer, HGPIN or ASAP. Summaries of the numbers of subjects meeting each of the specific criteria for group 1 (a through e) and Group 2 (a through h) will be provided.
In addition, summaries investigating the effect of baseline variables (such as age, family history of prostate cancer, prostate volume, percent free PSA, number of cores at the entry biopsy) on the occurrence of prostate cancer diagnoses and Gleason 7-10 diagnoses may be developed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Subjects on Dutasteride that meet the following criteria: 1. . A rise in PSA from nadir at any time post-nadir 2. . PSA change from baselin >0.2 mg/ml at any time post-baseline 3. . Abnormal DRE at any time post-baseline 4. . Free-PSA <12% at any time post-baseline 5. . At least one of the above 4 criteria 6. Subjects on Dutasteride that do not meet the above criteria |
| Group 2 | – | –Subjects on placebo treatment that meet the following criteria: 1. Change from baseline PSA between 0.0 and 0.35 (ie, 0.0 ≤ change from baseline PSA < 0.35) at any time post-baseline. Note that in REDUCE PSA was recorded to the nearest 0.1. 2. Abnormal DRE at any time post-baseline 3. Change from baseline PSA ≥ 0.35 at any time post-baseline 4. Change from baseline PSA ≥ 0.75 at any time post-baseline 5. PSA ≥ 2.5 at any time post-baseline 6. PSA ≥ 4.0 at any time post-baseline 7. Percent Free PSA < 12% at any time post-baseline 8. At least one of the above 7 criteria. 9. Subjects on placebo that do not meet the above criteria |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- REDUCE trial participants
Key inclusion criteria (15 listed)
- Group 1-subjects in the dutasteride treatment group who meet the following sets of criteria:
- A rise in PSA from nadir at any time post-nadir
- PSA change from baseline >0.2 ng/ml at any time post-baseline
- Abnormal DRE at any time post-baseline
- Free PSA<12% at any time post-baseline
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cancer detection risk among the groups in the "for cause" context
Time frame: 4 years
Determination of differences in cancer detection risk rate depending on cause vs no cause in that group compared to placebo
1 secondary outcome
Dutasteride as a key factor in the likelihood of "for cause" biopsy
Time frame: 4 years
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 23 Aug 2016.
- Results publication: PubMed 20357281Andriole 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.
- Individual participant dataSharing planned: No
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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.
Stephen Jones, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by The Cleveland Clinic at 1 site in United States.
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 15 inclusion and 0 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 23 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Cancer detection risk among the groups in the "for cause" context (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01529086, which also lists 1 linked publication.
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 23 Aug 2016.