Enzalutamide vs. Abiraterone in Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer (mCRPC)

NCT05520138 | Completed Results

• 2 other identifiers: C3431046Enza vs Abi rwOS in Medicare
• Study Type: observational
• Target: 5,506
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be a retrospective data analysis to compare outcomes between patients with chemotherapy-naïve metastatic castration-resistant prostate cancer (mCRPC) who initiated enzalutamide and those who initiated abiraterone using the 100% Fee-For-Service Medicare claims data. The study will address the following objectives: Primary objective: To compare overall survival (OS) in patients with chemotherapy-naïve mCRPC who initiated enzalutamide vs. abiraterone Secondary objectives:

• To compare OS in patients with chemotherapy-naïve mCRPC who received only enzalutamide without any subsequent therapy vs. abiraterone without any subsequent therapy
• To compare treatment duration and time to subsequent therapy in chemotherapy-naïve mCRPC patients initiating enzalutamide vs. abiraterone

Conditions

Prostatic Neoplasms, Castration-Resistant

Keywords

metastatic castration-resistant prostate cancer; mCRPC; enzalutamide; abiraterone; overall survival; OS; treatment duration

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS): Inverse Probability Treatment Weighting (IPTW)

  OS (time to death) was defined as the time from the initiation of enzalutamide or abiraterone (i.e., index date) to the date of death. Participants who did not die were censored at their last available follow-up, which was defined as the earlier of disenrollment from Medicare or end of data availability. Kaplan-Meier method was used for analysis.

  From index date to date of death or censoring date, whichever occurred first (from 10-Sep-2014 to 31-Dec-2020, approximately 76 months); retrospective data extracted and evaluated from study start date and until study completion (approximately 10 months)

Secondary Outcomes (3)

• OS Among Participants Without Any Subsequent Therapy: IPTW

  From index date to date of death or censoring date, whichever occurred first (from 10-Sep-2014 to 31-Dec-2020, approximately 76 months); retrospective data extracted and evaluated from study start date and until study completion (approximately 10 months)

• Treatment Duration: IPTW

  From index date to date of discontinuation event or censoring date, whichever occurred first(from 10-Sep-2014 to 31-Dec-2020, approximately 76months); retrospective data extracted and evaluated from start date and until completion(approximately 10months)

• Time to Subsequent Therapy: IPTW

  From index date to start of next line of therapy (from 10-Sep-2014 to 31-Dec-2020, approximately 76 months); retrospective data extracted and evaluated from study start date and until study completion (approximately 10 months)

Study Arms (2)

Enzalutamide cohort

Patients with mCRPC initiating enzalutamide

Drug: Enzalutamide

Abiraterone cohort

Patients with mCRPC initiating abiraterone

Drug: Abiraterone acetate

Interventions

Enzalutamide DRUG

As provided in real-world setting

Also known as: Xtandi

Enzalutamide cohort

Abiraterone acetate DRUG

As provided in real-world setting

Also known as: Yonsa, Zytiga

Abiraterone cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with chemotherapy-naïve mCRPC (aged ≥18 years) who initiated enzalutamide or abiraterone and met eligibility criteria will be included in the study. Patients will be identified from the 100% Fee-For-Service Medicare claims data.

You may qualify if:

• Male with ≥ 1 diagnosis claim for prostate cancer
• Have documented secondary metastasis code on or after the initial prostate cancer diagnosis
• Have initiated enzalutamide or abiraterone within 90 days prior to the metastasis date or on or after the metastasis date. The initiation date of enzalutamide or abiraterone will be defined as the index date.
• Have evidence of surgical or medical castration before the index date
• At least 18 years old at the index date
• Continuous eligibility for ≥ 12 months prior to the index date

You may not qualify if:

• Received chemotherapy, novel hormonal therapy, radium-223, or immunotherapy prior to the index date
• Had a prior history of other cancers

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Inc

New York, New York, 10017, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Prostatic Neoplasms, Castration-Resistant

Interventions

enzalutamide; Abiraterone Acetate

Condition Hierarchy (Ancestors)

Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Pfizer Inc.
• Organization: Pfizer ClinicalTrials.gov Call Center

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: August 26, 2022
• First Posted: August 29, 2022
• Study Start: August 29, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: September 27, 2024
• Results First Posted: September 27, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)