Metastatic Castration Sensitive Prostate Cancer (mCSPC)NCT07086651
A Study to Learn About Two Medicines (Apalutamide and Enzalutamide) in People With Metastatic Castration-sensitive Prostate Cancer (mCSPC)
An observational study of Metastatic Castration Sensitive Prostate Cancer (mCSPC) and Cancer of the Prostate, run by Pfizer at 1 site in United States.
Trial summary
The purpose of this study is to learn about how long apalutamide and enzalutamide are taken by men to treat mCSPC. Prostate cancer is one of the most common cancers in men. The prostate is a gland in the male body that helps make semen. Metastatic cancer is a cancer that has spread to other parts of the body. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Castration Sensitive Prostate Cancer (mCSPC), Cancer of the Prostate, Prostate Neoplasms
- What is being tested?
- Enzalutamide and Apalutamide
- How many people
- 1,300 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2025to 31 Oct 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: Men with metastatic castration-sensitive prostate cancer who initiated apalutamide or enzalutamide and met eligibility criteria will be included in the study. Patients will be identified from the Flatiron Health electronic health records database.
Who may be able to join
- Male patients diagnosed with metastatic prostate cancer
- Initiated apalutamide or enzalutamide for the first-line treatment of metastatic castration-sensitive prostate cancer (mCSPC). Initiation date of first treatment defines the index date.
- Index date on or after 1 January 2020
- Evidence of androgen deprivation therapy (ADT) use between 90 days prior to the index date and 6 months following the index date
- Age ≥18 years on the index date -≥6 months of clinical activity following the index date, unless the patient died
Who cannot join
- Evidence of castration-resistance prior to the index date
- Received chemotherapy, androgen receptor pathway inhibitor, radiopharmaceuticals, immunotherapy, PARP inhibitor, or estrogens prior to the index date
- Evidence of ADT use between 1 year and 91 days prior to the index date
- Had a prior history of other cancers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real-world Clinical Outcomes With Androgen Receptor Pathway Inhibitors (ARPIs) in Metastatic Castration-sensitive Prostate Cancer (mCSPC) in the Flatiron Health Electronic Health Records (EHR) Database
The purpose of this study is to learn about how long apalutamide and enzalutamide are taken by men to treat mCSPC.
Prostate cancer is one of the most common cancers in men. The prostate is a gland in the male body that helps make semen. Metastatic cancer is a cancer that has spread to other parts of the body. Castration-sensitive prostate cancer means the cancer is being controlled by keeping the testosterone levels as low as would be expected if the testicles were removed by surgery.
Read more
This is a real-world study, not a clinical study. This means that researchers will look at what happens when men receive the treatments prescribed by their own doctor as part of their usual healthcare treatment. In this study, researchers will use information from cancer clinics (Flatiron Health electronic health records).
The study will include patients' information from the database for men who:
- Were identified to have mCSPC.
- Started treatment with apalutamide or enzalutamide (index date) for mCSPC.
- Were 18 years of age or older on the index date. Men in this study will be taking apalutamide or enzalutamide for treatment of their mCSPC. The study will compare how long men take apalutamide or enzalutamide. This study will use patient information from cancer clinics. Information from start of apalutamide or enzalutamide treatment until information is available in the database will be used to describe how long patients receive treatment.
- Conditions
- Metastatic Castration Sensitive Prostate Cancer (mCSPC), Cancer of the Prostate, Prostate Neoplasms, Prostate Cancer
- Being tested
- Enzalutamide, Apalutamide
- Keywords
- enzalutamide, Xtandi, apalutamide, Erleada, mCSPC, metastatic castration-sensitive prostate cancer, treatment duration, metastatic hormone-sensitive prostate cancer, mHSPC
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnzalutamideDrug
Also called XTANDI
As provided in real-world setting
ApalutamideDrug
Also called ERLEADA
As provided in real-world setting
| Study group | Role | What they receive |
|---|---|---|
| Enzalutamide cohort | Patients initiating enzalutamide for mCSPC Receives: Drug: Enzalutamide | |
| Apalutamide cohort | Patients initiating apalutamide for mCSPC Receives: Drug: Apalutamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment duration
Treatment duration will be defined as the time from index date to the discontinuation (i.e., addition of subsequent treatment, treatment gap of 90 days, death) of the index treatment for any reason. Patients without an event will be censored on the date of last confirmed clinical activity.
Measured: Up to approximately 65 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start21 Jul 2025
- Primary completion31 Oct 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration Sensitive Prostate Cancer (mCSPC)Studies of the same condition, open and under way.
- More trials run by PfizerThe 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
- 1,300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Inc
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07086651
- Sponsor's protocol ID
- C3431053
- Status last verified
- Dec 2025
- First submitted
- 18 Jul 2025
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Clinical Outcomes With Androgen Receptor Pathway Inhibitors (ARPIs) in Metastatic Castration-sensitive Prostate Cancer (mCSPC) in the Flatiron Health Electronic Health Records (EHR) Database
- ClinicalTrials.gov ID
- NCT07086651
- Acronym / sponsor ID
- C3431053
- Conditions
- Metastatic Castration Sensitive Prostate Cancer (mCSPC), Cancer of the Prostate, Prostate Neoplasms, Prostate Cancer
- Keywords
- enzalutamide, Xtandi, apalutamide, Erleada, mCSPC, metastatic castration-sensitive prostate cancer, treatment duration, metastatic hormone-sensitive prostate cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,300 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Inc
- Study start
- 21 Jul 2025 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 25 Jul 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.
The purpose of this study is to learn about how long apalutamide and enzalutamide are taken by men to treat mCSPC.
Prostate cancer is one of the most common cancers in men. The prostate is a gland in the male body that helps make semen. Metastatic cancer is a cancer that has spread to other parts of the body. Castration-sensitive prostate cancer means the cancer is being controlled by keeping the testosterone levels as low as would be expected if the testicles were removed by surgery.
This is a real-world study, not a clinical study. This means that researchers will look at what happens when men receive the treatments prescribed by their own doctor as part of their usual healthcare treatment. In this study, researchers will use information from cancer clinics (Flatiron Health electronic health records).
The study will include patients' information from the database for men who:
- Were identified to have mCSPC.
- Started treatment with apalutamide or enzalutamide (index date) for mCSPC.
- Were 18 years of age or older on the index date. Men in this study will be taking apalutamide or enzalutamide for treatment of their mCSPC. The study will compare how long men take apalutamide or enzalutamide. This study will use patient information from cancer clinics. Information from start of apalutamide or enzalutamide treatment until information is available in the database will be used to describe how long patients receive treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enzalutamide cohort | – | Drug: EnzalutamidePatients initiating enzalutamide for mCSPC |
| Apalutamide cohort | – | Drug: ApalutamidePatients initiating apalutamide for mCSPC |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men with metastatic castration-sensitive prostate cancer who initiated apalutamide or enzalutamide and met eligibility criteria will be included in the study. Patients will be identified from the Flatiron Health electronic health records database.
Key inclusion criteria (5 listed)
- Male patients diagnosed with metastatic prostate cancer
- Initiated apalutamide or enzalutamide for the first-line treatment of metastatic castration-sensitive prostate cancer (mCSPC). Initiation date of first treatment defines the index date.
- Index date on or after 1 January 2020
- Evidence of androgen deprivation therapy (ADT) use between 90 days prior to the index date and 6 months following the index date
- Age ≥18 years on the index date -≥6 months of clinical activity following the index date, unless the patient died
Key exclusion criteria (4 listed)
- Evidence of castration-resistance prior to the index date
- Received chemotherapy, androgen receptor pathway inhibitor, radiopharmaceuticals, immunotherapy, PARP inhibitor, or estrogens prior to the index date
- Evidence of ADT use between 1 year and 91 days prior to the index date
- Had a prior history of other cancers
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 |
|---|---|---|
| EnzalutamideAlso: XTANDIAs provided in real-world setting | Drug | Enzalutamide cohort |
| ApalutamideAlso: ERLEADAAs provided in real-world setting | Drug | Apalutamide cohort |
Primary outcome
Treatment duration
Time frame: Up to approximately 65 months
Treatment duration will be defined as the time from index date to the discontinuation (i.e., addition of subsequent treatment, treatment gap of 90 days, death) of the index treatment for any reason. Patients without an event will be censored on the date of last confirmed clinical activity.
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 8 Dec 2025.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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Metastatic Castration Sensitive Prostate Cancer (mCSPC), Hormone Sensitive Prostate Cancer
Active, not recruitingObservational study
A Study to Learn About the Outcomes Between Study Medicines, Enzalutamide and Darolutamide Among Men With Metastatic Castration Sensitive Prostate Cancer (mCSPC)
Metastatic Castration Sensitive Prostate Cancer (mCSPC)
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.
Pfizer CT.gov Call Center study director
Pfizer
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 Metastatic Castration Sensitive Prostate Cancer (mCSPC) and Cancer of the Prostate, run by Pfizer 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 5 inclusion and 4 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 8 Dec 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 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.
What does the primary outcome measure?
Treatment duration (time frame: Up to approximately 65 months). It is what the study was designed to measure, not a finding.
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 8 Dec 2025.