Prostate CancerNCT06902441
Impact of New Hormonotherapy Drugs in Prostatic Cancer on the Risk of Cardiovascular Events : a Pharmacoepidemiology Study Using the French Health Care Claims Database
An observational study of Prostate Cancer, run by University Hospital, Caen at 1 site in France.
Trial summary
In prostate cancer, whether advanced or localized, hormone therapy is a key treatment. These therapies work by lowering male hormone levels to slow the growth of cancer. More recently, a new group of medications called Androgen Receptor Signaling Inhibitors (ARSIs) has been introduced. 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
- 52,000 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jan 2025to 30 Jun 2025
- 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 with prostatic cancer treated with an ARSI amoung Abiraterone Acetate, Enzalutamide or Apalutamide.
Who may be able to join
- Patients had to begin a treatment with Enzalutamide, Abiraterone or Apalutamide between the 01-01-2018 and the 31-12-2022
- Patients must have a unique ID in the database, to be able to link the data
Who cannot join
- Previous treatment with another novel androgen receptor signaling inhibitors
- Patients were excluded if they began a chemotherapy treatment in the 6 weeks following the beginning of Androgen Receptor Signaling Inhibitors (ARSI)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Androgen Receptor Signaling Inhibitors on Cardiovascular Events in Prostate Cancer: a Pharmacoepidemiology Study Using the French Health Care Claims Database
In prostate cancer, whether advanced or localized, hormone therapy is a key treatment. These therapies work by lowering male hormone levels to slow the growth of cancer.
More recently, a new group of medications called Androgen Receptor Signaling Inhibitors (ARSIs) has been introduced. These drugs are used alongside standard hormone therapy and are now prescribed for both advanced and high-risk localized prostate cancer.
Read more
There are two main types of ARSIs: abiraterone acetate, which blocks the body from making androgens, and enzalutamide, apalutamide, and darolutamide, which stop cancer cells from using these hormones. Doctors choose among them based on individual patient needs, as no one drug has been clearly shown to be better than the others. These treatments have significantly improved survival for many patients.
However, research shows that 30% of men with prostate cancer die from heart-related issues-a higher rate than in the general population. It's important to better understand how these treatments might be linked to heart risks.
One study found that all ARSIs increase the risk of serious heart problems. However, it did not take into account whether patients already had heart conditions, even though previous heart issues are known to increase the risk with certain drugs like abiraterone and enzalutamide.
That's why we're conducting a study using a large real-world database to compare the heart risks of abiraterone, enzalutamide, and apalutamide. We will take into account both patients' existing heart conditions and how long they were on treatment.
Read the detailed description
In prostate cancer, both in metastatic settings and in many localized cases, androgen suppression via Gonadotropin-Releasing Hormone (GnRH) agonists or antagonists remains the cornerstone of treatment. These androgen deprivation therapies (ADT) aim to reduce circulating androgen levels.
In recent years, Androgen Receptor Signaling Inhibitors (ARSIs) have emerged and are now prescribed in combination with ADT. These treatments have broad indications in metastatic settings and are also increasingly used in localized high-risk prostate cancer.
A conventional distinction is made between abiraterone acetate-a selective inhibitor of androgen synthesis that blocks CYP17-and other ARSIs that inhibit the androgen receptor, namely enzalutamide, apalutamide, and darolutamide. The indications for these treatments are often similar, with no clear evidence supporting the superiority of one over another. For instance, in synchronous metastatic hormone-sensitive prostate cancer, when treated with ARSIs combined with ADT, clinicians may choose between abiraterone acetate, apalutamide, or enzalutamide. Thus, the safety profile of these agents plays a crucial role in therapeutic decision-making. These next-generation hormonal therapies have significantly improved patient survival.
However, when examining causes of death among patients with prostate cancer, studies have shown that 30% of deaths are due to cardiovascular causes, with an excess risk compared to the general population. It is therefore essential to investigate these cardiovascular events and their associations with the treatments administered.
One meta-analysis identified an increased risk of high-grade cardiovascular toxicities associated with all next-generation hormonal therapies (HR 1.75; 95% CI: 1.50-2.04). This excess risk was observed for each ARSI individually. However, the meta-analysis could not account for patients' cardiovascular history, despite demonstrated associations between pre-existing cardiovascular conditions and the risk of cardiovascular toxicity with abiraterone acetate and enzalutamide.
For these reasons, we aimed to compare cardiovascular toxicities associated with abiraterone, enzalutamide, and apalutamide using a large real-world database, taking into account pre-existing cardiovascular comorbidities as well as treatment exposure duration.
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, Androgen Receptor Signaling Inhibitors, Cardiovascular toxicity, Hormonotherapy, Pharmacoepidemiology
- Medical subject headings
- Prostatic Neoplasms
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 |
|---|---|---|
| Apalutamide | Data collected about patients treated with Apalutamide | |
| Abiraterone Acetate | Data collected about patients treated with Abiraterone Acetate | |
| Enzalutamide | Data collected about patients treated with Enzalutamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk of hospitalization for cardiovascular cause
The primary objective of this study was to compare the risk of hospitalization for cardiovascular reasons among the different Androgen Receptor Signaling Inhibitors (ARSI). This outcome was evaluated by the occurrence of a hospitalization for one of these reasons as the principal diagnosis.
Measured: From the beginning of the ARSI to the first date among : death, end of hormonotherapy, study endpoint date (31-12-2023) or outcome
Secondary outcomes (7)
Risk of hospitalization for hearth failure
One of the secondary objective of this study was to compare the risk of hospitalization for heart failure amoung the different Androgen Receptor Signaling Inhibitors (ARSI). This outcome was evaluated by the occurrence of a hospitalization for heart failure as the principal diagnosis (International Classification of Diseases, 10th Edition; code I50).
Measured: From the beginning of the ARSI to the first date among : death, end of hormonotherapy, study endpoint date (31-12-2023) or outcome
Risk of hospitalization for atrial fibrillation
One of the secondary objective of this study was to compare the risk of hospitalization for atrial fibrillation or flutter amoung the different Androgen Receptor Signaling Inhibitors (ARSI). This outcome was evaluated by the occurrence of a hospitalization for atrial fibrillation or flutter as the principal diagnosis (International Classification of Diseases, 10th Edition; code I48).
Measured: From the beginning of the ARSI to the first date among : death, end of hormonotherapy, study endpoint date (31-12-2023) or outcome
Risk of hospitalization for ischemic heart disease
One of the secondary objective of this study was to compare the risk of hospitalization for ischemic heart disease amoung the different Androgen Receptor Signaling Inhibitors (ARSI). This outcome was evaluated by the occurrence of a hospitalization for ischemic heart disease as the principal diagnosis (International Classification of Diseases, 10th Edition; code I20-I25).
Measured: From the beginning of the ARSI to the first date among : death, end of hormonotherapy, study endpoint date (31-12-2023) or outcome
Risk of hospitalization for hypertensive disease
One of the secondary objective of this study was to compare the risk of hospitalization for hypertensive disease amoung the different Androgen Receptor Signaling Inhibitors (ARSI). This outcome was evaluated by the occurrence of a hospitalization for hypertensive disease as the principal diagnosis (International Classification of Diseases, 10th Edition; code I10-I13; I15).
Measured: From the beginning of the ARSI to the first date among : death, end of hormonotherapy, study endpoint date (31-12-2023) or outcome
Risk of hospitalization for successfully resuscitated cardiac arrest
One of the secondary objective of this study was to compare the risk of hospitalization for resuscitated cardiac arrest amoung the different Androgen Receptor Signaling Inhibitors (ARSI). This outcome was evaluated by the occurrence of a hospitalization for resuscitated cardiac arrest as the principal diagnosis (International Classification of Diseases, 10th Edition; code I50)
Measured: From the beginning of the ARSI to the first date among : death, end of hormonotherapy, study endpoint date (31-12-2023) or outcome
Risk of death
Another secondary objective was to evaluate the risk of death under Androgen Receptor Signaling Inhibitors (ARSI) treatment. This objective was assessed by the occurrence of death, regardless of the cause.
Measured: From the beginning of the ARSI to the first date among : death, end of hormonotherapy, study endpoint date (31-12-2023)
Risk of new registration for long term illness
Finally, a further secondary objective was to compare the risk of a new registration for long-term illness due to cardiovascular reasons, according to the Androgen Receptor Signaling Inhibitors (ARSI) used.
Measured: From the beginning of the ARSI to the first date among : death, end of hormonotherapy, study endpoint date (31-12-2023) or outcome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2025
- Study start7 Jan 2025
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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 University Hospital, CaenThe 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
- Retrospective
- Enrolment
- 52,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06902441
- Sponsor's protocol ID
- 20250318
- Status last verified
- Mar 2025
- First submitted
- 24 Mar 2025
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Baser O, Samayoa G, Dwivedi A, AlSaleh S, Cigdem B, Kizilkaya E. Cardiovascular events among patients with prostate cancer treated with abiraterone and enzalutamide. Acta Oncol. 2024 Apr 9;63:137-146. doi: 10.2340/1651-226X.2024.20337.
PubMed 38591349Lu-Yao G, Nikita N, Keith SW, Nightingale G, Gandhi K, Hegarty SE, Rebbeck TR, Chapman A, Kantoff PW, Cullen J, Gomella L, Kelly WK. Mortality and Hospitalization Risk Following Oral Androgen Signaling Inhibitors Among Men with Advanced Prostate Cancer by Pre-existing Cardiovascular Comorbidities. Eur Urol. 2020 Feb;77(2):158-166. doi: 10.1016/j.eururo.2019.07.031. Epub 2019 Aug 13.
PubMed 31420248El-Taji O, Taktak S, Jones C, Brown M, Clarke N, Sachdeva A. Cardiovascular Events and Androgen Receptor Signaling Inhibitors in Advanced Prostate Cancer: A Systematic Review and Meta-Analysis. JAMA Oncol. 2024 Jul 1;10(7):874-884. doi: 10.1001/jamaoncol.2024.1549.
PubMed 38842801Ye Y, Zheng Y, Miao Q, Ruan H, Zhang X. Causes of Death Among Prostate Cancer Patients Aged 40 Years and Older in the United States. Front Oncol. 2022 Jul 1;12:914875. doi: 10.3389/fonc.2022.914875. eCollection 2022.
PubMed 35847902Ploussard G, Baboudjian M, Barret E, Brureau L, Fiard G, Fromont G, Olivier J, Dariane C, Mathieu R, Rozet F, Peyrottes A, Roubaud G, Renard-Penna R, Sargos P, Supiot S, Turpin L, Roupret M; Comite de Cancerologie de l'Association Francaise d'Urologie, Groupe Prostate, Maison de l'Urologie. French AFU Cancer Committee Guidelines - Update 2024-2026: Prostate cancer - Diagnosis and management of localised disease. Fr J Urol. 2024 Nov;34(12):102717. doi: 10.1016/j.fjurol.2024.102717.
PubMed 39581668
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Androgen Receptor Signaling Inhibitors on Cardiovascular Events in Prostate Cancer: a Pharmacoepidemiology Study Using the French Health Care Claims Database
- ClinicalTrials.gov ID
- NCT06902441
- Acronym / sponsor ID
- 20250318
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, Androgen Receptor Signaling Inhibitors, Cardiovascular toxicity, Hormonotherapy, Pharmacoepidemiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52,000 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 7 Jan 2025 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 30 Mar 2025 (actual)
- 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.
In prostate cancer, whether advanced or localized, hormone therapy is a key treatment. These therapies work by lowering male hormone levels to slow the growth of cancer.
More recently, a new group of medications called Androgen Receptor Signaling Inhibitors (ARSIs) has been introduced. These drugs are used alongside standard hormone therapy and are now prescribed for both advanced and high-risk localized prostate cancer.
There are two main types of ARSIs: abiraterone acetate, which blocks the body from making androgens, and enzalutamide, apalutamide, and darolutamide, which stop cancer cells from using these hormones. Doctors choose among them based on individual patient needs, as no one drug has been clearly shown to be better than the others. These treatments have significantly improved survival for many patients.
However, research shows that 30% of men with prostate cancer die from heart-related issues-a higher rate than in the general population. It's important to better understand how these treatments might be linked to heart risks.
One study found that all ARSIs increase the risk of serious heart problems. However, it did not take into account whether patients already had heart conditions, even though previous heart issues are known to increase the risk with certain drugs like abiraterone and enzalutamide.
That's why we're conducting a study using a large real-world database to compare the heart risks of abiraterone, enzalutamide, and apalutamide. We will take into account both patients' existing heart conditions and how long they were on treatment.
Detailed description
In prostate cancer, both in metastatic settings and in many localized cases, androgen suppression via Gonadotropin-Releasing Hormone (GnRH) agonists or antagonists remains the cornerstone of treatment. These androgen deprivation therapies (ADT) aim to reduce circulating androgen levels.
In recent years, Androgen Receptor Signaling Inhibitors (ARSIs) have emerged and are now prescribed in combination with ADT. These treatments have broad indications in metastatic settings and are also increasingly used in localized high-risk prostate cancer.
A conventional distinction is made between abiraterone acetate-a selective inhibitor of androgen synthesis that blocks CYP17-and other ARSIs that inhibit the androgen receptor, namely enzalutamide, apalutamide, and darolutamide. The indications for these treatments are often similar, with no clear evidence supporting the superiority of one over another. For instance, in synchronous metastatic hormone-sensitive prostate cancer, when treated with ARSIs combined with ADT, clinicians may choose between abiraterone acetate, apalutamide, or enzalutamide. Thus, the safety profile of these agents plays a crucial role in therapeutic decision-making. These next-generation hormonal therapies have significantly improved patient survival.
However, when examining causes of death among patients with prostate cancer, studies have shown that 30% of deaths are due to cardiovascular causes, with an excess risk compared to the general population. It is therefore essential to investigate these cardiovascular events and their associations with the treatments administered.
One meta-analysis identified an increased risk of high-grade cardiovascular toxicities associated with all next-generation hormonal therapies (HR 1.75; 95% CI: 1.50-2.04). This excess risk was observed for each ARSI individually. However, the meta-analysis could not account for patients' cardiovascular history, despite demonstrated associations between pre-existing cardiovascular conditions and the risk of cardiovascular toxicity with abiraterone acetate and enzalutamide.
For these reasons, we aimed to compare cardiovascular toxicities associated with abiraterone, enzalutamide, and apalutamide using a large real-world database, taking into account pre-existing cardiovascular comorbidities as well as treatment exposure duration.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Apalutamide | – | –Data collected about patients treated with Apalutamide |
| Abiraterone Acetate | – | –Data collected about patients treated with Abiraterone Acetate |
| Enzalutamide | – | –Data collected about patients treated with Enzalutamide |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with prostatic cancer treated with an ARSI amoung Abiraterone Acetate, Enzalutamide or Apalutamide.
Key inclusion criteria (2 listed)
- Patients had to begin a treatment with Enzalutamide, Abiraterone or Apalutamide between the 01-01-2018 and the 31-12-2022
- Patients must have a unique ID in the database, to be able to link the data
Key exclusion criteria (2 listed)
- Previous treatment with another novel androgen receptor signaling inhibitors
- Patients were excluded if they began a chemotherapy treatment in the 6 weeks following the beginning of Androgen Receptor Signaling Inhibitors (ARSI)
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
Risk of hospitalization for cardiovascular cause
Time frame: From the beginning of the ARSI to the first date among : death, end of hormonotherapy, study endpoint date (31-12-2023) or outcome
The primary objective of this study was to compare the risk of hospitalization for cardiovascular reasons among the different Androgen Receptor Signaling Inhibitors (ARSI). This outcome was evaluated by the occurrence of a hospitalization for one of these reasons as the principal diagnosis.
7 secondary outcomes
Risk of hospitalization for hearth failure
Time frame: From the beginning of the ARSI to the first date among : death, end of hormonotherapy, study endpoint date (31-12-2023) or outcome
Risk of hospitalization for atrial fibrillation
Time frame: From the beginning of the ARSI to the first date among : death, end of hormonotherapy, study endpoint date (31-12-2023) or outcome
Risk of hospitalization for ischemic heart disease
Time frame: From the beginning of the ARSI to the first date among : death, end of hormonotherapy, study endpoint date (31-12-2023) or outcome
Risk of hospitalization for hypertensive disease
Time frame: From the beginning of the ARSI to the first date among : death, end of hormonotherapy, study endpoint date (31-12-2023) or outcome
Risk of hospitalization for successfully resuscitated cardiac arrest
Time frame: From the beginning of the ARSI to the first date among : death, end of hormonotherapy, study endpoint date (31-12-2023) or outcome
Risk of death
Time frame: From the beginning of the ARSI to the first date among : death, end of hormonotherapy, study endpoint date (31-12-2023)
Risk of new registration for long term illness
Time frame: From the beginning of the ARSI to the first date among : death, end of hormonotherapy, study endpoint date (31-12-2023) or outcome
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 4 Jul 2025.
- Results publication: PubMed 38591349Baser O, Samayoa G, Dwivedi A, AlSaleh S, Cigdem B, Kizilkaya E. Cardiovascular events among patients with prostate cancer treated with abiraterone and enzalutamide. Acta Oncol. 2024 Apr 9;63:137-146. doi: 10.2340/1651-226X.2024.20337.
- Results publication: PubMed 31420248Lu-Yao G, Nikita N, Keith SW, Nightingale G, Gandhi K, Hegarty SE, Rebbeck TR, Chapman A, Kantoff PW, Cullen J, Gomella L, Kelly WK. Mortality and Hospitalization Risk Following Oral Androgen Signaling Inhibitors Among Men with Advanced Prostate Cancer by Pre-existing Cardiovascular Comorbidities. Eur Urol. 2020 Feb;77(2):158-166. doi: 10.1016/j.eururo.2019.07.031. Epub 2019 Aug 13.
- Results publication: PubMed 38842801El-Taji O, Taktak S, Jones C, Brown M, Clarke N, Sachdeva A. Cardiovascular Events and Androgen Receptor Signaling Inhibitors in Advanced Prostate Cancer: A Systematic Review and Meta-Analysis. JAMA Oncol. 2024 Jul 1;10(7):874-884. doi: 10.1001/jamaoncol.2024.1549.
- Results publication: PubMed 35847902Ye Y, Zheng Y, Miao Q, Ruan H, Zhang X. Causes of Death Among Prostate Cancer Patients Aged 40 Years and Older in the United States. Front Oncol. 2022 Jul 1;12:914875. doi: 10.3389/fonc.2022.914875. eCollection 2022.
- Results publication: PubMed 39581668Ploussard G, Baboudjian M, Barret E, Brureau L, Fiard G, Fromont G, Olivier J, Dariane C, Mathieu R, Rozet F, Peyrottes A, Roubaud G, Renard-Penna R, Sargos P, Supiot S, Turpin L, Roupret M; Comite de Cancerologie de l'Association Francaise d'Urologie, Groupe Prostate, Maison de l'Urologie. French AFU Cancer Committee Guidelines - Update 2024-2026: Prostate cancer - Diagnosis and management of localised disease. Fr J Urol. 2024 Nov;34(12):102717. doi: 10.1016/j.fjurol.2024.102717.
- Individual participant dataSharing planned: Undecided
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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, run by University Hospital, Caen 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 2 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 4 Jul 2025. 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?
Risk of hospitalization for cardiovascular cause (time frame: From the beginning of the ARSI to the first date among : death, end of hormonotherapy, study endpoint date (31-12-2023) or outcome). 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 NCT06902441, which also lists 5 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 4 Jul 2025.