Prostate CancerNCT00513721
Retrospective Study of Positive Biopsy Specimens on Patients Undergoing a Prostatectomy
An observational study of Prostate Cancer, run by Corewell Health East at 1 site in United States.
Trial summary
This is a review of prostate biopsy specimens which show capsular penetration or positive surgical margins. Patients had surgery performed at William Beaumont Hospital-Royal Oak, Michigan. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to May 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Males having undergone surgery for prostate cancer at William Beaumont Hospital-Royal Oak, Michigan
Who may be able to join
- Males having undergone surgery for prostate cancer at William Beaumont Hospital-Royal Oak, Michigan
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
William Beaumont Hospital
Royal Oak, Michigan, 48073
About this study
Official title: Do Positive Lateral Biopsy Cores on TRUS Directed Biopsies Predict Capsular Penetration and Positive Surgical Margins?
This is a review of prostate biopsy specimens which show capsular penetration or positive surgical margins. Patients had surgery performed at William Beaumont Hospital-Royal Oak, Michigan.
- Conditions
- Prostate Cancer
- Keywords
- prostate, prostate cancer, surgical margins, gleason score, positive lateral biopsies
- Medical subject headings
- Prostatic Neoplasms, Margins of Excision
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 |
|---|---|---|
| III | Prostate specimens with positive surgical margins. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2007 (estimated)
- Study startJul 2007
- Primary completionMay 2009
- Study completionMay 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
- Retrospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Investigators
- Fadi Eliya, MD, Principal investigator, Corewell Health East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00513721
- Sponsor's protocol ID
- E2007-087
- Status last verified
- May 2009
- First submitted
- 8 Aug 2007
- Last updated
- 5 May 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Positive Lateral Biopsy Cores on TRUS Directed Biopsies Predict Capsular Penetration and Positive Surgical Margins?
- ClinicalTrials.gov ID
- NCT00513721
- Acronym / sponsor ID
- E2007-087
- Conditions
- Prostate Cancer
- Keywords
- prostate, prostate cancer, surgical margins, gleason score, positive lateral biopsies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 9 Aug 2007 (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 prostate biopsy specimens which show capsular penetration or positive surgical margins. Patients had surgery performed at William Beaumont Hospital-Royal Oak, Michigan.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| III | – | –Prostate specimens with positive surgical margins. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Males having undergone surgery for prostate cancer at William Beaumont Hospital-Royal Oak, Michigan
Key inclusion criteria (1 listed)
- Males having undergone surgery for prostate cancer at William Beaumont Hospital-Royal Oak, Michigan
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
Not reported in the source record.
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 5 May 2009.
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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.
Fadi Eliya, MD principal investigator
Corewell Health East
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 Corewell Health East 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 1 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 5 May 2009. 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.
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 5 May 2009.