Prostate CancerPReCISENCT00966095
PRostate Cancer Individual Signature Evaluation Trial in Patients Undergoing Scheduled Prostate Biopsy
An observational study of Prostate Cancer, run by Source MDx at 17 sites in United States.
Trial summary
The purpose of this study is to develop and validate a blood-based diagnostic test that will predict prostate biopsy outcome as positive or negative for prostate cancer. Such a test will serve to reduce the number of unnecessary prostate biopsies. Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 1,200 participants
- Where
- 17 sitesUnited States
- Study dates
- Dec 2009to not given
- 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 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Men scheduled for a prostate biopsy
Who may be able to join
- Male over the age of 40.
- Patient is scheduled for prostate biopsy for one or more of the following reasons:
- PSA > 2.5 ng/ml
- Rising PSA (>0.5 ng/ml/yr)
- Lower PSA value with other risk factors for prostate cancer (e.g.; family history)
- Abnormal DRE
- Percent free PSA <15%
- No prior history of prostate cancer or prostate biopsy.
Who cannot join
- Unable or unwilling to provide informed consent
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
University of Michigan
Ann Arbor, Michigan, 48105
Johns Hopkins University Brady Urological Institute
Baltimore, Maryland, 21287
Brigham and Women's Hospital/ Dana Farber Cancer Institute
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
University of Chicago Medical Center
Chicago, Illinois, 60637
Urology Clinics of North Texas
Dallas, Texas, 75231
The Urology Center of Colorado
Denver, Colorado, 80211
Karmanos Cancer Institute Wayne State University
Detroit, Michigan, 48201
Durham VA Medical Center
Durham, North Carolina, 27705
Duke University Medical Center
Durham, North Carolina, 27710
University Urology Associates
New York, New York, 10016
Mount Sinai Medical Center
New York, New York, 10029
Mayo Clinic
Rochester, Minnesota, 55905
Urology San Antonio Research
San Antonio, Texas, 78229
San Bernardino Urological Associates
San Bernardino, California, 92404
University of Washington Department of Urology
Seattle, Washington, 98195
Bay State Clinical Trials
Watertown, Massachusetts, 02472
About this study
Official title: A Prospective, Multi-Center PRostate Cancer Individual Signature Evaluation Trial (PReCISE) in Patients Undergoing Scheduled Prostate Biopsy
The purpose of this study is to develop and validate a blood-based diagnostic test that will predict prostate biopsy outcome as positive or negative for prostate cancer. Such a test will serve to reduce the number of unnecessary prostate biopsies.
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer
- 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 |
|---|---|---|
| men scheduled for prostate biopsy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
ability of whole blood gene expression to predict biopsy outcome
Measured: pre-biopsy
Secondary outcomes (1)
Prediction of tumor aggressiveness using whole blood gene expression
Measured: post-biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2009 (estimated)
- Study startDec 2009
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
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Source MDx
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- William Oh, MD, Principal investigator, Mt. Sinai School of MedicineDanute "Bunki" Bankaitis-Davis, PhD, Principal investigator, Source MDxLisa Siconolfi, PhD, Principal investigator, Source MDxPhilip Kantoff, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00966095
- Sponsor's protocol ID
- PReCISE
- Acronym
- PReCISE
- Status last verified
- Nov 2010
- First submitted
- 24 Aug 2009
- Last updated
- 25 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-Center PRostate Cancer Individual Signature Evaluation Trial (PReCISE) in Patients Undergoing Scheduled Prostate Biopsy
- ClinicalTrials.gov ID
- NCT00966095
- Acronym / sponsor ID
- PReCISE / PReCISE
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Source MDxIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- First posted
- 26 Aug 2009 (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 purpose of this study is to develop and validate a blood-based diagnostic test that will predict prostate biopsy outcome as positive or negative for prostate cancer. Such a test will serve to reduce the number of unnecessary prostate biopsies.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| men scheduled for prostate biopsy | – | – |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men scheduled for a prostate biopsy
Key inclusion criteria (8 listed)
- Male over the age of 40.
- Patient is scheduled for prostate biopsy for one or more of the following reasons:
- No prior history of prostate cancer or prostate biopsy.
Key exclusion criteria (1 listed)
- Unable or unwilling to provide informed consent
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
ability of whole blood gene expression to predict biopsy outcome
Time frame: pre-biopsy
1 secondary outcome
Prediction of tumor aggressiveness using whole blood gene expression
Time frame: post-biopsy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2010.
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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.
William Oh, MD principal investigator
Mt. Sinai School of Medicine
Danute "Bunki" Bankaitis-Davis, PhD principal investigator
Source MDx
Lisa Siconolfi, PhD principal investigator
Source MDx
17 sites 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 Source MDx at 17 sites 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 8 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 25 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites 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?
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?
ability of whole blood gene expression to predict biopsy outcome (time frame: pre-biopsy). 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 25 Nov 2010.