Prostate CancerNCT00447616
Prostatectomy Prospective Database
An observational study of Prostate Cancer, run by Kenneth Peters, MD at 1 site in United States.
Trial summary
The purpose of establishing the database is to evaluate the effects of surgical removal of the prostate (prostatectomy) and cryosurgery on prostate cancer, quality of life, and overall health. 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
- 896 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2003to 7 Apr 2015
- 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: Patients having prostatectomy or cryosurgery for the treatment of prostate cancer at William Beaumont Hospital.
Who may be able to join
- males greater than 18 years of age
- patients having prostatectomy or cryosurgery for the treatment of prostate cancer at William Beaumont Hospital.
Who cannot join
- dementia
Trial locations and contacts
1 site in 1 country.
United States1 site
William Beaumont Hospital
Royal Oak, Michigan, 48073
About this study
Official title: Prostatectomy Database
The purpose of establishing the database is to evaluate the effects of surgical removal of the prostate (prostatectomy) and cryosurgery on prostate cancer, quality of life, and overall health.
Read the detailed description
The purpose of establishing the database is to evaluate the effects of surgical removal of the prostate (prostatectomy) and cryosurgery on prostate cancer, quality of life, and overall health. Participation in the study will allow collection of medical information related to prostate cancer treatment from hospital and doctor's office records. Questionnaires will be completed reflecting bladder, bowel, and sexual function, and quality of life at three, six, twelve, eighteen, and twenty-four months after surgery, and yearly thereafter.
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Prostatectomy
- 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 posted15 Mar 2007 (estimated)
- Study startOct 2003
- Primary completion7 Apr 2015
- Study completion7 Apr 2015
Why it stopped: Lack of funding
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
- Other
- Time perspective
- Prospective
- Enrolment
- 896 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kenneth Peters, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kenneth Peters, MD, Corewell Health East
- Investigators
- Kenneth M Peters, M.D., Principal investigator, Corewell Health East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00447616
- Sponsor's protocol ID
- 2003-214
- Status last verified
- Dec 2017
- First submitted
- 13 Mar 2007
- Last updated
- 26 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostatectomy Database
- ClinicalTrials.gov ID
- NCT00447616
- Acronym / sponsor ID
- 2003-214
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Prostatectomy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of funding
- Enrolment
- 896 participants (actual)
- Lead sponsor
- Kenneth Peters, MDUniversity, hospital or other
- Study start
- Oct 2003
- Primary completion
- 7 Apr 2015 (actual)
- Study completion
- 7 Apr 2015 (actual)
- First posted
- 15 Mar 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.
The purpose of establishing the database is to evaluate the effects of surgical removal of the prostate (prostatectomy) and cryosurgery on prostate cancer, quality of life, and overall health.
Detailed description
The purpose of establishing the database is to evaluate the effects of surgical removal of the prostate (prostatectomy) and cryosurgery on prostate cancer, quality of life, and overall health. Participation in the study will allow collection of medical information related to prostate cancer treatment from hospital and doctor's office records. Questionnaires will be completed reflecting bladder, bowel, and sexual function, and quality of life at three, six, twelve, eighteen, and twenty-four months after surgery, and yearly thereafter.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients having prostatectomy or cryosurgery for the treatment of prostate cancer at William Beaumont Hospital.
Key inclusion criteria (2 listed)
- males greater than 18 years of age
- patients having prostatectomy or cryosurgery for the treatment of prostate cancer at William Beaumont Hospital.
Key exclusion criteria (1 listed)
- dementia
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 funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2017.
- 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.
Kenneth M Peters, M.D. 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 Kenneth Peters, MD 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: stopped early, as of the sponsor's last update on 26 Dec 2017. 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 funding). 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 26 Dec 2017.