Prostate CancerADTCRNCT02895230
Androgen-Deprivation Therapy and Cardiovascular Risk: A Nationwide Population-based Cohort Study
An observational study of Prostate Cancer and Androgen-deprivation Therapy, run by Rennes University Hospital at 1 site in France.
Trial summary
The research focuses on the safety profile of androgen-deprivation therapy (ADT). The hypothesis is that safety issue, as regards to cardiovascular risk, is not homogenous across the spectrum of androgen-deprivation therapy modalities. Our study will encompass all ADT modalities including intermittent ADT. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Androgen-deprivation Therapy
- How many people
- 38,690 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2016to 17 May 2022
- 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: Using the French Health Reimbursement Agency database and French hospital discharge database, the investigators will identify all men with prostate cancer who had either, at least one dispensation in a 1.5-year period of an androgen-deprivation therapy or a hospitalization for orchiectomy. The French Health Insurance System covers the entire French population (65.3 million inhabitants in 2012).
Who may be able to join
- Adults men, age greater 18 years,
- Affiliation to French Health System,
- Diagnosis of prostate cancer
- At least one dispensation (leading to a reimbursement claim) in a 1.5 year period of an androgen-deprivation therapy or a hospitalization for orchiectomy.
Who cannot join
- Orchiectomy for another reason that prostate cancer.
- Patients treated with both Gonadotropin Releasing Hormone agonists and bilateral orchiectomy will be excluded from analyses.
Trial locations and contacts
1 site in 1 country.
About this study
The research focuses on the safety profile of androgen-deprivation therapy (ADT). The hypothesis is that safety issue, as regards to cardiovascular risk, is not homogenous across the spectrum of androgen-deprivation therapy modalities. Our study will encompass all ADT modalities including intermittent ADT.
ADT is a cornerstone therapy in prostate cancer management. Decisions about ADT should weigh improvements in cancer-specific outcomes against potential increased risks for cardiovascular diseases. The potential for harm from ADT should be more precisely defined according to the type of ADT. Those potential risks underscore the importance of better understanding benefits of ADT, especially in contexts where data are still lacking.ADT is also indicated in sexually deviant behavior.
Read the detailed description
Our study is a nationwide population-based prospective cohort on 4 years thanks to the French Health Reimbursement Agency database (Système National d'Information Inter-Régimes de l'Assurance Maladie, SNIIRAM) and French hospital discharge database (Programme de Médicalisation des Systèmes d'Information; PMSI). A unique civil registration number has been assigned to all French residents and this number unambiguously links those two databases.
- Conditions
- Prostate Cancer, Androgen-deprivation Therapy
- Being tested
- Standard care
- Keywords
- Androgen-deprivation therapy, Prostate cancer, Nationwide population-based cohort, Myocardial infarction, Ischemic stroke
- Medical subject headings
- Prostatic Neoplasms, Myocardial Infarction, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard careOther
An extraction from French Health Reimbursement Agency database and French hospital discharge database will be performed using a simplified request based on inclusion criteria but the extraction will encompass a 4-year period to ensure sufficient follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Men with prostate cancer with androgen-deprivation therapy | Using the French Health Reimbursement Agency database and French hospital discharge database, the investigators will identify all men with prostate cancer who had either, at least one dispensation in a 1.5-year period (1st July 2010 to 31st December 2011) of an androgen-deprivation therapy or a hospitalization for orchiectomy. The French Health Insurance System covers the entire French population (65.3 million inhabitants in 2012). Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between androgen-deprivation therapy and vascular stroke
To investigate the association between different modalities of androgen-deprivation therapy (continuous or intermittent use of Gonadotropin Releasing Hormone (GnRH) agonists, GnRH antagonists, oral antiandrogens, or orchiectomy) and myocardial infarction or ischemic stroke in French men with prostate cancer.
Measured: 2 years after the beginning of androgen-deprivation therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study start1 Jan 2016
- Primary completion21 Mar 2016
- Study completion17 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- 38,690 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuel OGER, MD, PhD, Study director, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02895230
- Sponsor's protocol ID
- 35RC13_8812
- Acronym
- ADTCR
- Status last verified
- Dec 2022
- First submitted
- 6 Sep 2016
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Scailteux LM, Vincendeau S, Balusson F, Leclercq C, Happe A, Le Nautout B, Polard E, Nowak E, Oger E. Androgen deprivation therapy and cardiovascular risk: No meaningful difference between GnRH antagonist and agonists-a nationwide population-based cohort study based on 2010-2013 French Health Insurance data. Eur J Cancer. 2017 May;77:99-108. doi: 10.1016/j.ejca.2017.03.002. Epub 2017 Apr 5.
PubMed 28390298Scailteux LM. Response to letter - Androgen deprivation therapy and cardiovascular risk: No meaningful difference between GnRH antagonist and agonists. Eur J Cancer. 2017 Dec;87:204. doi: 10.1016/j.ejca.2017.06.042. Epub 2017 Jul 26. No abstract available.
PubMed 28756060
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Androgen-Deprivation Therapy and Cardiovascular Risk: A Nationwide Population-based Cohort Study
- ClinicalTrials.gov ID
- NCT02895230
- Acronym / sponsor ID
- ADTCR / 35RC13_8812
- Conditions
- Prostate Cancer, Androgen-deprivation Therapy
- Keywords
- Androgen-deprivation therapy, Prostate cancer, Nationwide population-based cohort, Myocardial infarction, Ischemic stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38,690 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 21 Mar 2016 (actual)
- Study completion
- 17 May 2022 (actual)
- First posted
- 9 Sep 2016 (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 research focuses on the safety profile of androgen-deprivation therapy (ADT). The hypothesis is that safety issue, as regards to cardiovascular risk, is not homogenous across the spectrum of androgen-deprivation therapy modalities. Our study will encompass all ADT modalities including intermittent ADT.
ADT is a cornerstone therapy in prostate cancer management. Decisions about ADT should weigh improvements in cancer-specific outcomes against potential increased risks for cardiovascular diseases. The potential for harm from ADT should be more precisely defined according to the type of ADT. Those potential risks underscore the importance of better understanding benefits of ADT, especially in contexts where data are still lacking.ADT is also indicated in sexually deviant behavior.
Detailed description
Our study is a nationwide population-based prospective cohort on 4 years thanks to the French Health Reimbursement Agency database (Système National d'Information Inter-Régimes de l'Assurance Maladie, SNIIRAM) and French hospital discharge database (Programme de Médicalisation des Systèmes d'Information; PMSI). A unique civil registration number has been assigned to all French residents and this number unambiguously links those two databases.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Men with prostate cancer with androgen-deprivation therapy | – | Other: Standard careUsing the French Health Reimbursement Agency database and French hospital discharge database, the investigators will identify all men with prostate cancer who had either, at least one dispensation in a 1.5-year period (1st July 2010 to 31st December 2011) of an androgen-deprivation therapy or a hospitalization for orchiectomy. The French Health Insurance System covers the entire French population (65.3 million inhabitants in 2012). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Using the French Health Reimbursement Agency database and French hospital discharge database, the investigators will identify all men with prostate cancer who had either, at least one dispensation in a 1.5-year period of an androgen-deprivation therapy or a hospitalization for orchiectomy. The French Health Insurance System covers the entire French population (65.3 million inhabitants in 2012).
Key inclusion criteria (4 listed)
- Adults men, age greater 18 years,
- Affiliation to French Health System,
- Diagnosis of prostate cancer
- At least one dispensation (leading to a reimbursement claim) in a 1.5 year period of an androgen-deprivation therapy or a hospitalization for orchiectomy.
Key exclusion criteria (2 listed)
- Orchiectomy for another reason that prostate cancer.
- Patients treated with both Gonadotropin Releasing Hormone agonists and bilateral orchiectomy will be excluded from analyses.
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 |
|---|---|---|
| Standard careAn extraction from French Health Reimbursement Agency database and French hospital discharge database will be performed using a simplified request based on inclusion criteria but the extraction will encompass a 4-year period to ensure sufficient follow-up. | Other | Men with prostate cancer with androgen-deprivation therapy |
Primary outcome
Association between androgen-deprivation therapy and vascular stroke
Time frame: 2 years after the beginning of androgen-deprivation therapy
To investigate the association between different modalities of androgen-deprivation therapy (continuous or intermittent use of Gonadotropin Releasing Hormone (GnRH) agonists, GnRH antagonists, oral antiandrogens, or orchiectomy) and myocardial infarction or ischemic stroke in French men with prostate cancer.
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 1 Aug 2023.
- Results publication: PubMed 28390298Scailteux LM, Vincendeau S, Balusson F, Leclercq C, Happe A, Le Nautout B, Polard E, Nowak E, Oger E. Androgen deprivation therapy and cardiovascular risk: No meaningful difference between GnRH antagonist and agonists-a nationwide population-based cohort study based on 2010-2013 French Health Insurance data. Eur J Cancer. 2017 May;77:99-108. doi: 10.1016/j.ejca.2017.03.002. Epub 2017 Apr 5.
- Results publication: PubMed 28756060Scailteux LM. Response to letter - Androgen deprivation therapy and cardiovascular risk: No meaningful difference between GnRH antagonist and agonists. Eur J Cancer. 2017 Dec;87:204. doi: 10.1016/j.ejca.2017.06.042. Epub 2017 Jul 26. No abstract available.
- 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.
Emmanuel OGER, MD, PhD study director
Rennes University Hospital
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 Androgen-deprivation Therapy, run by Rennes University Hospital at 1 site in France.
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 4 inclusion and 2 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 1 Aug 2023. 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 France. 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.
What does the primary outcome measure?
Association between androgen-deprivation therapy and vascular stroke (time frame: 2 years after the beginning of androgen-deprivation therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02895230, which also lists 2 linked publications.
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 Aug 2023.