Which prostate cancer drug delays the next treatment longer? a Real-World showdown

NCT ID NCT07779590

Knowledge-focused Sponsor: Pfizer Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 21, 2026 · Last updated Aug 21, 2026

Summary

This study looks back at medical records to compare how long men with metastatic castration-sensitive prostate cancer (cancer that has spread but still responds to hormone therapy) go before needing a next treatment after starting either enzalutamide or darolutamide, both combined with standard hormone therapy (ADT). It includes about 4,700 men whose data are in a large prostate cancer database. The goal is to see whether one drug is associated with a longer time to the next treatment in everyday clinical practice.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
enzalutamide plus androgen deprivation therapy (ADT) or darolutamide plus ADT
What this could lead to
If one drug proves better at delaying the need for a next treatment, it could help guide doctors in choosing between these two options for men with metastatic prostate cancer.
What could go wrong
This is an observational study using existing medical records, not a controlled experiment, so differences between groups may be due to patient characteristics rather than the drugs themselves. Results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 4,700 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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: 1. Has an International Classification of Diseases (ICD) diagnosis of PC (ICD-9 185x or ICD-10 C61x) 2. At least two documented clinic visits on different days in the Flatiron network occurring on or after 01 January 2011 3. Has evidence of diagnosis of PC with an initial or metastatic diagnosis date. 2. Evidence of mCSPC diagnosis date, as defined below: a. 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 3. 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). 4. 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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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How to take part

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  1. The official record

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