Prostate CancerPSADvNCT01484808
The Utility of PSADv (PSA Density Velocity) While on Dutasteride for Predicting Prostate Cancer Incidence and Grade and Stage
An observational study of Prostate Cancer, run by University Urological Associates Inc. at 1 site in United States.
Trial summary
This is a review of previously published data from a large prostate cancer prevention study known as REDUCE. It is the investigators intention to review whether prostate specific antigen (PSA) velocity (change over time) will predict the presence of prostate cancer and its grade and stage (severity). Read more about this study
- Who is it for?
- Ages 50 to 74 years, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 6,600 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to May 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 74 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Men with PSA elevation (>=4), 50-74 years old with negative biopsy of the prostate at study entry
Who may be able to join
- Men,
- 50-74 years old with elevated PSA (>=4) along with negative entry biopsy of the prostate who had a subsequent biopsy by 24 months.
Who cannot join
- Any positive biopsy of the prostate indicative of cancer upon entry
Trial locations and contacts
1 site in 1 country.
Samuel Elsamra, MD contact
United States1 site
Division of Urology, Brown University
Providence, Rhode Island, 02903
Steven I Cohen, MD
About this study
Official title: Retrospective Review of Reduce Data to Determine the Utility of PSADv While on Dutasteride for Predicting Prostate Cancer Incidence and Grade and Stage
This is a review of previously published data from a large prostate cancer prevention study known as REDUCE. It is the investigators intention to review whether prostate specific antigen (PSA) velocity (change over time) will predict the presence of prostate cancer and its grade and stage (severity).
Read the detailed description
This is a review of previously published data from a large prostate cancer prevention study known as REDUCE that utilized a 5 ARI, dutasteride. It is the investigators intention to review whether PSA velocity (change over time) will predict the presence of prostate cancer and its grade and stage (severity) by two year biopsy. The investigator will review and compare data to a previously published study of similar design with finasteride.
- Conditions
- Prostate Cancer
- Keywords
- PSA Density, Prostate Cancer, Prostate Biopsy, PSA
- Medical subject headings
- Prostatic Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionApr 2012 (estimated)
- Study completionMay 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 6,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Urological Associates Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven I Cohen, MD, Principal investigator, University Urological Associates Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01484808
- Sponsor's protocol ID
- 8DUT115799
- Acronym
- PSADv
- Status last verified
- Nov 2011
- First submitted
- 30 Nov 2011
- Last updated
- 2 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Review of Reduce Data to Determine the Utility of PSADv While on Dutasteride for Predicting Prostate Cancer Incidence and Grade and Stage
- ClinicalTrials.gov ID
- NCT01484808
- Acronym / sponsor ID
- PSADv / 8DUT115799
- Conditions
- Prostate Cancer
- Keywords
- PSA Density, Prostate Cancer, Prostate Biopsy, PSA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 6,600 participants (estimated)
- Lead sponsor
- University Urological Associates Inc.University, hospital or other
- Study start
- Jan 2012
- Primary completion
- Apr 2012 (estimated)
- Study completion
- May 2012 (estimated)
- First posted
- 2 Dec 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.
This is a review of previously published data from a large prostate cancer prevention study known as REDUCE. It is the investigators intention to review whether prostate specific antigen (PSA) velocity (change over time) will predict the presence of prostate cancer and its grade and stage (severity).
Detailed description
This is a review of previously published data from a large prostate cancer prevention study known as REDUCE that utilized a 5 ARI, dutasteride. It is the investigators intention to review whether PSA velocity (change over time) will predict the presence of prostate cancer and its grade and stage (severity) by two year biopsy. The investigator will review and compare data to a previously published study of similar design with finasteride.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 50 to 74 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men with PSA elevation (>=4), 50-74 years old with negative biopsy of the prostate at study entry
Key inclusion criteria (2 listed)
- Men,
- 50-74 years old with elevated PSA (>=4) along with negative entry biopsy of the prostate who had a subsequent biopsy by 24 months.
Key exclusion criteria (1 listed)
- Any positive biopsy of the prostate indicative of cancer upon entry
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2011.
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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.
Samuel Elsamra, MD contact
Steven I Cohen, MD principal investigator
University Urological Associates Inc.
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 University Urological Associates Inc. 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 2 Dec 2011. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Steven I Cohen, MD (4012727799 ext. 1232, sicppmd@cox.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 2 Dec 2011.