Prostate CancerNCT00651222
Influence of Hormone Therapy on Heart Attack Incidence in Men Undergoing Prostate Brachytherapy
An observational study of Prostate Cancer and Cardiovascular Death, run by Prostate Cancer Foundation of Chicago at 1 site in United States.
Trial summary
The purpose of this study is to review cause of death in patients undergoing prostate brachytherapy at a single institution. Furthermore, we are analyzing patients undergoing androgen deprivation therapy and whether or not this contributed to cardiovascular deaths, specifically myocardial infarction. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer, Cardiovascular Death
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Prostate cancer patients treated with prostate brachytherapy at an ambulatory surgery center
Who may be able to join
- Deceased anytime after prostate brachytherapy treatment
Who cannot join
- Patients whose cause of death was unable to be determined
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Androgen Suppression Therapy for Prostate Cancer on the Timing and Onset of Fatal Myocardial Infarctions in Men Undergoing Prostate Brachytherapy
The purpose of this study is to review cause of death in patients undergoing prostate brachytherapy at a single institution. Furthermore, we are analyzing patients undergoing androgen deprivation therapy and whether or not this contributed to cardiovascular deaths, specifically myocardial infarction.
- Conditions
- Prostate Cancer, Cardiovascular Death
- Being tested
- No intervention was required
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention was requiredOther
Also called Death records were reviewed, therefore, there was no intervention
Death records were reviewed, therefore, there was no intervention
| Study group | Role | What they receive |
|---|---|---|
| 1 | All deceased patients who underwent brachytherapy at Chicago Prostate Center between 10/14/1997 and 6/15/2007 Receives: Other: No intervention was required |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2008 (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
- Cohort
- Time perspective
- Retrospective
Sponsor and investigators
- Lead sponsor
- Prostate Cancer Foundation of Chicago
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00651222
- Sponsor's protocol ID
- MI-PB
- Status last verified
- Mar 2008
- First submitted
- 31 Mar 2008
- Last updated
- 2 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Androgen Suppression Therapy for Prostate Cancer on the Timing and Onset of Fatal Myocardial Infarctions in Men Undergoing Prostate Brachytherapy
- ClinicalTrials.gov ID
- NCT00651222
- Acronym / sponsor ID
- MI-PB
- Conditions
- Prostate Cancer, Cardiovascular Death
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Prostate Cancer Foundation of ChicagoUniversity, hospital or other
- First posted
- 2 Apr 2008 (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 review cause of death in patients undergoing prostate brachytherapy at a single institution. Furthermore, we are analyzing patients undergoing androgen deprivation therapy and whether or not this contributed to cardiovascular deaths, specifically myocardial infarction.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: No intervention was requiredAll deceased patients who underwent brachytherapy at Chicago Prostate Center between 10/14/1997 and 6/15/2007 |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Prostate cancer patients treated with prostate brachytherapy at an ambulatory surgery center
Key inclusion criteria (1 listed)
- Deceased anytime after prostate brachytherapy treatment
Key exclusion criteria (1 listed)
- Patients whose cause of death was unable to be determined
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention was requiredAlso: Death records were reviewed, therefore, there was no interventionDeath records were reviewed, therefore, there was no intervention | Other | 1 |
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 2 Apr 2008.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Cardiovascular Death, run by Prostate Cancer Foundation of Chicago 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 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: finished, as of the sponsor's last update on 2 Apr 2008. 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 2 Apr 2008.