NCT06013475

Brief Summary

This is an observational cohort study in men with non-metastatic castration-resistant prostate cancer who received their usual treatment, which is 'Androgen receptor inhibitors' (ARIs) including darolutamide, enzalutamide, and apalutamide. The main purpose of this study is to collect data on the length of time men with nmCRPC continued treatment with darolutamide, enzalutamide, or apalutamide as prescribed by their doctors. Researchers will only include men who had not been treated with any new type of medication that blocks the action of hormones. The data will come from an electronic health record database called Precision Point Specialty (PPS) Prostate Cancer Electronic Medical Record (EMR) for men in the United States of America. EMR data will be verified and supplemented via patient chart review. Data collected will be from January 2019 to September 2023. .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,375

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 18, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 28, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

August 31, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 28, 2024

Completed
Last Updated

June 12, 2025

Status Verified

June 1, 2025

Enrollment Period

10 months

First QC Date

August 18, 2023

Last Update Submit

June 11, 2025

Conditions

Non-metastatic Castration-resistant Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Time to ARI treatment discontinuation

    Retrospective analysis from 01-Aug-2019 to 30 Sep 2023

Secondary Outcomes (5)

  • Reasons for ARI treatment discontinuation

    Retrospective analysis from 01-Aug-2019 to 30 Sep 2023

  • Proportion of patients, who switched to another ARI therapy

    Retrospective analysis from 01-Aug-2019 to 30 Sep 2023

  • Frequency of adverse events

    Retrospective analysis from 01-Aug-2019 to 30 Sep 2023

  • Time to progression to mCRPC

    Retrospective analysis from 01-Aug-2019 to 30 Sep 2023

  • Dose modification of initial ARI

    Retrospective analysis from 01-Aug-2019 to 30 Sep 2023

Study Arms (3)

Apalutamide

Drug: Apalutamide

Darolutamide

Drug: Darolutamide (BAY 1841788)

Enzalutamide

Drug: Enzalutamide

Interventions

ApalutamideDRUG

Decision by the treating physician

Apalutamide
Darolutamide (BAY 1841788)DRUG

Decision by the treating physician

Also known as: Nubeqa
Darolutamide
EnzalutamideDRUG

Decision by treating physician

Enzalutamide

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult men previously not treated with a novel antihormonal agent and starting the initial ARI treatment for nmCRPC during the study period, in US community urology practices

You may qualify if:

  • Men diagnosed with prostate cancer.
  • Diagnosis of nmCRPC prior to or within 90 days after the first ARI treatment initiation
  • Treatment with Darolutamide, Enzalutamide, or Apalutamide initiated for the first time
  • Age ≥ 18 years at treatment start
  • At least 6 months of Electro-Medical-Record activity after the treatment start unless the patient died earlier than 6 months.

You may not qualify if:

  • Evidence of metastatic disease before or 30 days after treatment start
  • Prior history of other primary cancers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bayer

Whippany, New Jersey, 07981, United States

Location

Related Links

MeSH Terms

Interventions

apalutamidedarolutamideenzalutamide

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2023

First Posted

August 28, 2023

Study Start

August 31, 2023

Primary Completion

June 28, 2024

Study Completion

October 28, 2024

Last Updated

June 12, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Locations

US(1)