Prostate CancerNCT00355758
UCI 03-72 Prostate Cancer Detection by Serum Proteomic Profiling
An observational study of Prostate Cancer, run by University of California, Irvine at 1 site in United States.
Trial summary
: Researchers would like to see if a new test called SELDI (Surface Enhanced Laser Desorption Ionization) analysis can predict biopsy results better than PSA tests. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to Jun 2009
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Those who have prostate cancer and are scheduled for robotic prostatectomy to treat the disease and are seen at the Urology Clinic of the University of California, Irvine.
Who may be able to join
- For all subjects:
- Men 50 years of age or older.
- Serum PSA greater than or equal to 2.5 ng/ml and less then or equal to 10.0 ng/ml determined by a measurement within the past six months, and/or digital rectal exam suspicious for prostate cancer as determined by the patient's Urologist.
- It has been determined by the treating physician that a prostate biopsy is clinically indicated.
- Patients will have already been diagnosed with prostate cancer and scheduled for a radical prostatectomy.
- For study on treatment effect
- Men with clinically localized prostate cancer (total PSA < 20 ng/ml and clinical T2b or less).
- Men with organ confined prostate cancer as determined by final pathologic diagnosis.
Who cannot join
- Known prostate cancer or prior treatment for prostate cancer.
- Acute prostatitis.
- Untreated urinary tract infection.
- Presence of Foley catheter or any urethral instrumentation in the previous 48 hours.
- Hormonal therapies including LHRH agonists, oral anti-androgens, estrogenic compounds, Proscar or any phytotherapies within the previous 6 months.
- Men with non-organ confined prostate cancer.
- Men with detectable serum PSA levels more than 1 months following radical prostatectomy.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Irvine
Orange, California, 92868
About this study
Official title: Prostate Cancer Detection by Serum Proteomic Profiling
: Researchers would like to see if a new test called SELDI (Surface Enhanced Laser Desorption Ionization) analysis can predict biopsy results better than PSA tests.
Read the detailed description
A blood sample of approximately 30 cc will be collected prior to the patients standard of care radical prostatectomy surgery. This blood will be used for the SELDI analysis. The remainder of the blood sample will be stored and may be used for the PSA test at a later date. The patient will have a final blood draw 3 months to 1 year following surgery.
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer Detection by Serum Proteomic Profiling
- 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 posted25 Jul 2006 (estimated)
- Study startApr 2005
- Study completionJun 2009
Why it stopped: Lack of personnel
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.
- More trials run by University of California, IrvineThe 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
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Investigators
- Atreaya Dash, MD, Principal investigator, University of California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00355758
- Sponsor's protocol ID
- 2004-3561
- Status last verified
- Aug 2010
- First submitted
- 24 Jul 2006
- Last updated
- 1 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostate Cancer Detection by Serum Proteomic Profiling
- ClinicalTrials.gov ID
- NCT00355758
- Acronym / sponsor ID
- 2004-3561
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer Detection by Serum Proteomic Profiling
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of personnel
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- Apr 2005
- Study completion
- Jun 2009 (actual)
- First posted
- 25 Jul 2006 (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.
: Researchers would like to see if a new test called SELDI (Surface Enhanced Laser Desorption Ionization) analysis can predict biopsy results better than PSA tests.
Detailed description
A blood sample of approximately 30 cc will be collected prior to the patients standard of care radical prostatectomy surgery. This blood will be used for the SELDI analysis. The remainder of the blood sample will be stored and may be used for the PSA test at a later date. The patient will have a final blood draw 3 months to 1 year following surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Those who have prostate cancer and are scheduled for robotic prostatectomy to treat the disease and are seen at the Urology Clinic of the University of California, Irvine.
Key inclusion criteria (8 listed)
- For all subjects:
- For study on treatment effect
- Men with clinically localized prostate cancer (total PSA < 20 ng/ml and clinical T2b or less).
- Men with organ confined prostate cancer as determined by final pathologic diagnosis.
Key exclusion criteria (7 listed)
- Men with non-organ confined prostate cancer.
- Men with detectable serum PSA levels more than 1 months following radical prostatectomy.
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
The study was stopped early (reason given: Lack of personnel). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 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.
Atreaya Dash, MD principal investigator
University of California
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 of California, Irvine 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 8 inclusion and 7 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: stopped early, as of the sponsor's last update on 1 Sep 2010. 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 was stopped early (reason given: Lack of personnel). 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.
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 1 Sep 2010.