A Study to Learn About Novel Hormonal Therapies in People With Metastatic Castration-Sensitive Prostate Cancer (mCSPC)

An observational study of Prostatic Neoplasms, run by Pfizer at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to learn about how long novel hormonal therapies are taken by men to treat mCSPC. Novel hormonal therapies in this study include study medicines abiraterone, apalutamide, and enzalutamide. Prostate cancer is one of the most common cancers in men. Read more about this study

Who is it for?: Ages 65 years and older, men only
Conditions the study is for: Prostatic Neoplasms
What is being tested?: Novel hormonal therapy
How many people: 3,017 participants
Where: 1 siteUnited States
Study dates: 4 Oct 2023to 18 Dec 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 65 years and older
Men only
No healthy volunteers
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 100% Fee-For-Service Medicare claims data.

Who may be able to join

Male with ≥ 1 diagnosis claim for prostate cancer
Have documented secondary metastasis code on or after the initial prostate cancer diagnosis
Have initiated novel hormonal therapy (abiraterone, apalutamide, or enzalutamide) within 30 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.
Have a claim for androgen deprivation therapy (ADT) within 90 days prior to or within 30 days after the index date
≥65 years old 12 months prior to the index date
Continuous enrollment in Medicare Parts A, B, and D for ≥12 months prior to the index date and ≥6 months following the index date (unless death)

Who cannot join

Claims indicating ≥8 weeks of continuous ADT use between 90 and 365 days prior to the index date, which may indicate castration-resistance
Received chemotherapy, novel hormonal therapy, radium-223, PARP inhibitor, immunotherapy, or surgical castration prior to the index date
Had a prior history of other cancers

Trial locations and contacts

1 site in 1 country.

United States1 site

Pfizer, Inc
New York, New York, 10001

Other trials in United States

About this study

Official title: Novel Hormonal Therapies (NHTs) for the Treatment of Metastatic Castration-sensitive Prostate Cancer (mCSPC) in the Medicare Population

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 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 insurance claim information from Medicare claims data.

The study will include patients' information from the database for men who:

Were identified to have mCSPC.
Started treatment with novel hormonal therapy (index date) for mCSPC.
Were 65 years of age or older one year before index date.

Men in this study will be taking novel hormonal therapy for treatment of their mCSPC. We will describe how long men take novel hormonal therapy. This study will use patient information from insurance claims. It will take information one year before start of novel hormonal treatment until the end of insurance period or 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
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 groups in NCT06072196
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 NHT Treatment
Treatment duration was defined as the time from the initial claim date of NHT (abiraterone, apalutamide, or enzalutamide) until the end of observation for any of the following reasons: (i) end of data availability (December 31, 2022), (ii) participant's date of death, (iii) day before a treatment switch, (iv) day of treatment discontinuation (a 90-day gap in days supply was considered as discontinuation). Retrospective retrieved data collected was evaluated for approximately 1.2 years of this study. Kaplan-Meier method was used for estimation.
Measured: 2 years (retrospective data observation duration)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Oct 202318 Dec 2024

First posted10 Oct 2023
Study start4 Oct 2023
Primary completion18 Dec 2024
Study completion18 Dec 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: 3,017 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06072196
Sponsor's protocol ID: C3431049
Other IDs: NCT06072196
Status last verified: Dec 2025
First submitted: 2 Oct 2023
Last updated: 31 Dec 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
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Daily Adaptive Post-Prostatectomy With Stereotactic Ablative Radiotherapy in Patients With Prostate Cancer
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Use of Tracking Devices to Locate Abnormalities During Invasive Procedures
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All Prostatic Neoplasms trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Novel Hormonal Therapies (NHTs) for the Treatment of Metastatic Castration-sensitive Prostate Cancer (mCSPC) in the Medicare Population
ClinicalTrials.gov ID: NCT06072196
Acronym / sponsor ID: C3431049
Conditions: Prostatic Neoplasms
Keywords: metastatic castration-sensitive prostate cancer, mCSPC, metastatic hormone-sensitive prostate cancer, mHSPC, enzalutamide, abiraterone, treatment duration
Study type: Observational
Recruitment status: Completed
Enrolment: 3,017 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Collaborators: Astellas Pharma Inc
Study start: 4 Oct 2023 (actual)
Primary completion: 18 Dec 2024 (actual)
Study completion: 18 Dec 2024 (actual)
First posted: 10 Oct 2023 (actual)
Results: Posted 31 Dec 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The study will include patients' information from the database for men who:

Were identified to have mCSPC.
Started treatment with novel hormonal therapy (index date) for mCSPC.
Were 65 years of age or older one year before index date.

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: 65 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: 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 100% Fee-For-Service Medicare claims data.

Key inclusion criteria (6 listed)

Male with ≥ 1 diagnosis claim for prostate cancer
Have documented secondary metastasis code on or after the initial prostate cancer diagnosis
Have initiated novel hormonal therapy (abiraterone, apalutamide, or enzalutamide) within 30 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.
Have a claim for androgen deprivation therapy (ADT) within 90 days prior to or within 30 days after the index date
≥65 years old 12 months prior to the index date

Key exclusion criteria (3 listed)

Claims indicating ≥8 weeks of continuous ADT use between 90 and 365 days prior to the index date, which may indicate castration-resistance
Received chemotherapy, novel hormonal therapy, radium-223, PARP inhibitor, immunotherapy, or surgical castration 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
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 NHT Treatment
Time frame: 2 years (retrospective data observation duration)
Treatment duration was defined as the time from the initial claim date of NHT (abiraterone, apalutamide, or enzalutamide) until the end of observation for any of the following reasons: (i) end of data availability (December 31, 2022), (ii) participant's date of death, (iii) day before a treatment switch, (iv) day of treatment discontinuation (a 90-day gap in days supply was considered as discontinuation). Retrospective retrieved data collected was evaluated for approximately 1.2 years of this study. Kaplan-Meier method was used for estimation.

Results and safety

Results posted to the registry on 31 Dec 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Novel Hormonal Therapy	3,017	3,017

Primary outcome: Duration of NHT Treatment

Time frame: 2 years (retrospective data observation duration). Median (95% Confidence Interval). Unit: Months

Measure	Novel Hormonal Therapy n = 3017
Value	11.9 (11.4 to 12.7)

Population analysed: Analysis population included all eligible participants who met inclusion/exclusion criteria, whose data was retrieved and observed in the study.

Adverse events

Time frame: Not applicable as adverse events and all-cause mortality were not planned to be evaluated for the study. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Novel Hormonal Therapy	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 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.

Related trials for Prostatic Neoplasms

RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Active, not recruiting
Daily Adaptive Post-Prostatectomy With Stereotactic Ablative Radiotherapy in Patients With Prostate Cancer
Malignant Prostate Neoplasm
Enrolling by invitation
Use of Tracking Devices to Locate Abnormalities During Invasive Procedures
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RecruitingObservational study
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RecruitingPhase 1
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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 6 inclusion and 3 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 31 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?

Yes. Results are posted in the registry (first posted 31 Dec 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 NHT Treatment (time frame: 2 years (retrospective data observation duration)). 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 NCT06072196.

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 31 Dec 2025.