Which prostate cancer drug delays the next treatment longer? a Real-World showdown
NCT ID NCT07779590
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
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About 4,700 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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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 Hide 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
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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