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Metastatic Castration Sensitive Prostate Cancer (mCSPC)NCT07779590

A Study to Learn About the Outcomes Between Study Medicines, Enzalutamide and Darolutamide Among Men With Metastatic Castration Sensitive Prostate Cancer (mCSPC)

An observational study of Metastatic Castration Sensitive Prostate Cancer (mCSPC), run by Pfizer at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this real-world study of electronic medical records is to look back to compare the time to next treatment after initial treatment with enzalutamide or darolutamide in addition to androgen deprivation therapy (ADT). Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
darolutamide plus androgen deprivation therapy and Enzalutamide plus androgen deprivation therapy
How many people
4,700 participants
Where
1 siteUnited States
Study dates
19 Aug 2026to 15 Nov 2026
Phase
Observational
Are there results?
Not yet: the study is under way

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: This is a retrospective cohort study of patients with mCSPC initiating first-line (1L) enzalutamide plus ADT or darolutamide plus ADT without other life-prolonging therapies in the US identified from the Flatiron's Prostate Cancer Panoramic Database. The dataset will include all protocol-required, retrospective patient-level data available for eligible patients from 01 January 2011, through the expected data cutoff date of 31 March 2026, which may be updated if newer data cuts become available at the time of the analysis.

Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:

  1. Patients included in the Flatiron Prostate Cancer Panoramic dataset:
  2. Has an International Classification of Diseases (ICD) diagnosis of PC (ICD-9 185x or ICD-10 C61x)
  3. At least two documented clinic visits on different days in the Flatiron network occurring on or after 01 January 2011
  4. Has evidence of diagnosis of PC with an initial or metastatic diagnosis date.
  5. Evidence of mCSPC diagnosis date, as defined below:
  6. The mCSPC diagnosis date is determined using information on the date of metastatic diagnosis and the CSPC status. The data of metastatic diagnosis is the earliest date of the first confirmation of metastatic prostate cancer using the following hierarchy, where available: 1) Biopsy specimen collection date from the pathology report; 2) Physician reported date of biopsy; 3) Date of the radiology scan that indicated metastatic disease, if it was later confirmed by the physician; 4) Physician reported date of metastatic diagnosis. CSPC status is determined based on the following hierarchical evidence sources: 1) metastatic diagnosis date (if metastatic at initial diagnosis); 2) Explicit clinician documentation of CSPC; 3) Earliest ADT start date; 4) Clinician documented response or PSA decline while on ADT
  7. Has evidence of treatment with enzalutamide or darolutamide in combination with ADT in the 1L mCSPC setting , on or after 01 August 2022. Note: The index date is the start of the ARPI in combination with ADT (i.e., the first episode of ARPI treatment, which can occur up to 90 days after initiation of 1L therapy if ADT is initiated before the ARPI).
  8. Index date is no more than 30 days prior to or 6 months after the mCSPC diagnosis date

Patients meeting any of the following criteria will not be included in the study:

  1. Birth sex reported as female or unknown
  2. Age <18 years at index date
  3. Evidence of receiving a clinical study drug on or prior to index date
  4. Diagnosed with neuroendocrine and/or small cell PC on or prior to index
  5. Diagnosed with additional malignancies, excluding nonmelanoma skin cancer, at any time prior to index date
  6. Index date <6 months prior to data cutoff date
  7. Received multiple ARPIs or ARPI in combination with any drug other than ADT or first-generation anti-androgen treatments prior to and up to 28 days after index date
  8. Evidence of ADT or first-generation anti-androgen treatment between 1 year and 91 days prior to index date
  9. Evidence of an orchiectomy occurring more than 90 days prior to index date
  10. Evidence of CRPC any time prior or up to 90 days after the index date
  11. Evidence of treatments for mCRPC on or prior to index date
  12. Has a Line 0 as defined by Flatiron line of therapy (LOT) business rules, indicating potentially missing treatment data at the start of mCSPC setting
  13. Received docetaxel prior to and up to 120 days after index date

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Pfizer

    New York, New York, 10001

Other trials in United States

About this study

Official title: Real-World Outcomes Among Patients Receiving Enzalutamide Plus ADT or Darolutamide Plus ADT in Metastatic Castration Sensitive Prostate Cancer (mCSPC)

The purpose of this real-world study of electronic medical records is to look back to compare the time to next treatment after initial treatment with enzalutamide or darolutamide in addition to androgen deprivation therapy (ADT). ADT is a hormone therapy used to stop testosterone from being released or to prevent it from acting on prostate cells. The study includes men with metastatic castration-sensitive prostate cancer (mCSPC). This is a cancer that has spread outside the prostate to other parts of the body, but can still be successfully managed by lowering male hormones like testosterone. The study uses data from the Flatiron's Prostate Cancer Panoramic Database. This data base contains information on prostate cancer patients such as their clinical characteristics, lab, vitals, treatments and outcomes.

This study is seeking participants included in the Flatiron Prostate Cancer Panoramic dataset who:

Read more
  • Have a diagnosis of prostate cancer (PC) that has spread to other parts of the body
  • With at least two documented clinic visits on different days in the Flatiron network occurring on or after 01 January 2011
  • Has proof of treatment with enzalutamide or darolutamide in combination with ADT as a first line treatment
  • The treatment with enzalutamide or darolutamide in combination with ADT is no more than 30 days prior to or 6 months after the mCSPC diagnosis date

All participants in this study received at least 1 dose of enzalutamide or darolutamide in combination with ADT. The experiences of the participants receiving the enzalutamide or darolutamide will be looked at.

Participants will take part in this study for at least 6 months. During this time, they will have at least 2 documented clinic visits from 01 January 2011 to 31 March 2026. These visits will be updated if newer information becomes available at the time of the analysis.

Being tested
darolutamide plus androgen deprivation therapy, Enzalutamide plus androgen deprivation therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • darolutamide plus androgen deprivation therapyDrug

    As provided in real world setting

  • Enzalutamide plus androgen deprivation therapyDrug

    As provided in real world setting

Study groups in NCT07779590
Study groupRoleWhat they receive
darolutamide plus androgen deprivation therapydarolutamide plus androgen deprivation therapy
Receives: Drug: darolutamide plus androgen deprivation therapy
enzalutamide plus androgen deprivation therapyenzalutamide plus androgen deprivation therapy
Receives: Drug: Enzalutamide plus androgen deprivation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Median Real-world time to next treatment (rwTTNT)

    Measured: time from index date to the start of the next treatment course (August 1, 2022- March 31, 2026)

Timeline

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

  1. First posted21 Aug 2026
  2. Study start19 Aug 2026
  3. Primary completion15 Nov 2026 (estimated)
  4. Study completion15 Nov 2026 (estimated)

Resources

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
4,700 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07779590
Sponsor's protocol ID
C3431054
Status last verified
Oct 2026
First submitted
18 Aug 2026
Last updated
6 Oct 2026
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.

Questions about this trial

What is this clinical trial studying?

An observational study of Metastatic Castration Sensitive Prostate Cancer (mCSPC), 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?

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: under way, not looking for participants, as of the sponsor's last update on 6 Oct 2026. 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?

This study is still under way. Results are not available in the source record yet.

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?

Median Real-world time to next treatment (rwTTNT) (time frame: time from index date to the start of the next treatment course (August 1, 2022- March 31, 2026)). 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 NCT07779590.

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 6 Oct 2026.

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