Prostatic NeoplasmsNCT06151418
A Study to Learn About Novel Hormonal Therapies (NHTs) for Metastatic Castration-sensitive Prostate Cancer (mCSPC) in People Who Were in the Armed Forces
An observational study of Prostatic Neoplasms, run by Pfizer at 1 site in United States.
Trial summary
The purpose of this study is to learn about- for how long are NHTs taken by men to treat mCSPC. NHTs in this study include study medicines: abiraterone, apalutamide, enzalutamide. Prostate cancer is one of the most common cancers in men. The prostate is a gland in the male body that helps make semen. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Neoplasms
- What is being tested?
- Novel hormonal therapy
- How many people
- 2,313 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Nov 2023to 23 Apr 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 novel hormonal therapy (abiraterone, apalutamide, or enzalutamide) and met eligibility criteria will be included in the study. Patients will be identified from the National Veterans Affairs Health Care Network.
Who may be able to join
- Male with ≥ 1 diagnosis claim for prostate cancer
- Had documented secondary metastasis code on or after the initial prostate cancer diagnosis
- Had initiated novel hormonal therapy (abiraterone, apalutamide, or enzalutamide) within 90 days prior to the metastasis date or on or after the metastasis date. The initiation date of the earliest novel hormonal therapy will be defined as the index date
- ≥18 years old on index date
- Continuous enrollment for at least 365 days before index date
- Evidence to be castration-sensitive:
- No prior surgical castration any time prior to the index date or no medical castration with ≥8 weeks of continuous use within -90 to -365 days prior to the index date, OR
- Diagnosis of hormone sensitive malignancy status within 90 days before the index date
Who cannot join
- Evidence of castration-resistance prior to the index date
- Received other prostate cancer treatment including NHT, non-steroidal anti-androgen (NSAA), chemotherapy, immunotherapy, radium 223, lutetium Lu 177 vipivotide tetraxetan, ketoconazole, or PARP inhibitor prior to the index date
- Had diagnosis code indicating hormone resistance prior to the index date
- A rise in prostate-specific antigen from the nadir by ≥2 ng/mL after castration
- Had a prior history of other cancers (except non-melanoma skin cancer)
- Participation in a clinical trial during the 30 days before the index date
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Novel Hormonal Therapy (NHT) for Treating Patients With Metastatic Castration-Sensitive Prostate Cancer (mCSPC): An Analysis of National Veterans Affairs Health Care Network Data
The purpose of this study is to learn about- for how long are NHTs taken by men to treat mCSPC. NHTs in this study include study medicines:
- abiraterone,
- apalutamide,
- enzalutamide.
Read more
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. Most prostate cancers need male hormones to grow. When cancer cells respond to treatment that lowers male hormones, this is known as castration-sensitive prostate cancer.
This is a real-world study, not a clinical trial. 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 National Veteran's Affairs (VA) Health Care Network.
The study will include patients' information from the database for men who:
- were identified to have mCSPC.
- started treatment with NHT for mCSPC.
- were 18 years of age or older at start of NHT.
Men in this study will be taking NHT for treatment of their mCSPC. The study will explain:
- how long men take the therapy.
- how long it takes to start next therapy.
This study will use patient information about medications and treatments from VA data. This study will use information one year before start of NHT until information is available.
- Conditions
- Prostatic Neoplasms
- Being tested
- Novel hormonal therapy
- Keywords
- metastatic castration-sensitive prostate cancer, mCSPC, metastatic hormone-sensitive prostate cancer, mHSPC, enzalutamide, abiraterone, treatment duration, time to next therapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel hormonal therapyDrug
Also called Abiraterone(Yonsa, Zytiga), Apalutamide(Erleada), Enzalutamide(Xtandi)
As provided in real-world setting
| Study group | Role | What they receive |
|---|---|---|
| Novel hormonal therapy cohort | Patients initiating novel hormonal therapy (abiraterone, apalutamide or enzalutamide) for mCSPC Receives: Drug: Novel hormonal therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Therapy (DOT)
DOT was defined as the time from the index date to the date of NHT discontinuation for any reason. Discontinuation of the current NHT was defined as a treatment gap of at least 90 days (the last day with days' supply before the gap as discontinuation date), the initiation of a new therapy, or death, whichever came first. Initiation of a new therapy was defined by switching to a different NHT, switching to or augmentation with different therapies. Participants who did not experience discontinuation were censored at the end of data availability. Index date was defined as the initiation date of NHT in 1L (any date) from 1-January-2020 to 31-December-2022. Retrospective data was retrieved using the Veterans' Health Administration data for period of 01-Jan-2020 to 30-Sep-2023 (45 months).
Measured: From start of index treatment to date of NHT discontinuation or censoring date, whichever came first, during maximum follow-up of 45 months
Secondary outcomes (1)
Time to Next Therapy (TTNT)
TTNT was defined as the time from the index date to the initiation date of a new therapy. Initiation of a new therapy was defined by switching to a different NHT, switching to different therapies. Participants who did not initiate a new therapy were censored at the end of data availability or death, whichever came first. Index date was defined as the initiation date of NHT in 1L (any date) from 1-January-2020 to 31-December-2022. Retrospective data was retrieved using the Veterans' Health Administration data for period of 01-Jan-2020 to 30-Sep-2023 (45 months). Kaplan-Meier method was used for analysis.
Measured: From start of index treatment until date of new therapy, or censoring date, whichever came first; during maximum follow-up of 45 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2023
- Study start22 Nov 2023
- Primary completion23 Apr 2024
- Study completion23 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostatic NeoplasmsStudies 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
- 2,313 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
- NCT06151418
- Sponsor's protocol ID
- C3431052
- Other IDs
- NCT06151418
- Status last verified
- Jun 2025
- First submitted
- 21 Nov 2023
- Last updated
- 4 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- 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 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Hormonal Therapy (NHT) for Treating Patients With Metastatic Castration-Sensitive Prostate Cancer (mCSPC): An Analysis of National Veterans Affairs Health Care Network Data
- ClinicalTrials.gov ID
- NCT06151418
- Acronym / sponsor ID
- C3431052
- Conditions
- Prostatic Neoplasms
- Keywords
- metastatic castration-sensitive prostate cancer, mCSPC, metastatic hormone-sensitive prostate cancer, mHSPC, enzalutamide, abiraterone, treatment duration, time to next therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,313 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma Inc
- Study start
- 22 Nov 2023 (actual)
- Primary completion
- 23 Apr 2024 (actual)
- Study completion
- 23 Apr 2024 (actual)
- First posted
- 30 Nov 2023 (actual)
- Results
- Posted 4 Jun 2025
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- for how long are NHTs taken by men to treat mCSPC. NHTs in this study include study medicines:
- abiraterone,
- apalutamide,
- enzalutamide.
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. Most prostate cancers need male hormones to grow. When cancer cells respond to treatment that lowers male hormones, this is known as castration-sensitive prostate cancer.
This is a real-world study, not a clinical trial. 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 National Veteran's Affairs (VA) Health Care Network.
The study will include patients' information from the database for men who:
- were identified to have mCSPC.
- started treatment with NHT for mCSPC.
- were 18 years of age or older at start of NHT.
Men in this study will be taking NHT for treatment of their mCSPC. The study will explain:
- how long men take the therapy.
- how long it takes to start next therapy.
This study will use patient information about medications and treatments from VA data. This study will use information one year before start of NHT until information is available.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Novel hormonal therapy cohort | – | Drug: Novel hormonal therapyPatients initiating novel hormonal therapy (abiraterone, apalutamide or enzalutamide) 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 novel hormonal therapy (abiraterone, apalutamide, or enzalutamide) and met eligibility criteria will be included in the study. Patients will be identified from the National Veterans Affairs Health Care Network.
Key inclusion criteria (8 listed)
- Male with ≥ 1 diagnosis claim for prostate cancer
- Had documented secondary metastasis code on or after the initial prostate cancer diagnosis
- Had initiated novel hormonal therapy (abiraterone, apalutamide, or enzalutamide) within 90 days prior to the metastasis date or on or after the metastasis date. The initiation date of the earliest novel hormonal therapy will be defined as the index date
- ≥18 years old on index date
- Continuous enrollment for at least 365 days before index date
Key exclusion criteria (6 listed)
- Evidence of castration-resistance prior to the index date
- Had a prior history of other cancers (except non-melanoma skin cancer)
- Participation in a clinical trial during the 30 days before the index date
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 |
|---|---|---|
| Novel hormonal therapyAlso: Abiraterone(Yonsa, Zytiga), Apalutamide(Erleada), Enzalutamide(Xtandi)As provided in real-world setting | Drug | Novel hormonal therapy cohort |
Primary outcome
Duration of Therapy (DOT)
Time frame: From start of index treatment to date of NHT discontinuation or censoring date, whichever came first, during maximum follow-up of 45 months
DOT was defined as the time from the index date to the date of NHT discontinuation for any reason. Discontinuation of the current NHT was defined as a treatment gap of at least 90 days (the last day with days' supply before the gap as discontinuation date), the initiation of a new therapy, or death, whichever came first. Initiation of a new therapy was defined by switching to a different NHT, switching to or augmentation with different therapies. Participants who did not experience discontinuation were censored at the end of data availability. Index date was defined as the initiation date of NHT in 1L (any date) from 1-January-2020 to 31-December-2022. Retrospective data was retrieved using the Veterans' Health Administration data for period of 01-Jan-2020 to 30-Sep-2023 (45 months).
1 secondary outcome
Time to Next Therapy (TTNT)
Time frame: From start of index treatment until date of new therapy, or censoring date, whichever came first; during maximum follow-up of 45 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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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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 Prostatic Neoplasms, 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 8 inclusion and 6 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 Jun 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?
Yes. Results are posted in the registry (first posted 4 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Duration of Therapy (DOT) (time frame: From start of index treatment to date of NHT discontinuation or censoring date, whichever came first, during maximum follow-up of 45 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 4 Jun 2025.