Multi-academic Center Study of Xofigo Patients

Completed

• Conditions: Prostate Cancer, Castration Resistant
• Interventions: Drug: Xofigo; Drug: Taxotere; Drug: Jevtana

• Registration Number: NCT03419442
• Lead Sponsor: Bayer

Brief Summary

The study will be conducted from a real-world perspective to describe treatment sequences involving radium-223 and chemotherapy in patients with metastatic castrate resistant prostate cancer (mCRPC) and assess overall survival (OS) associated with treatment sequences involving radium-223 and chemotherapy. While clinical trials of radium-223 has demonstrated a survival benefit in the treatment of mCRPC, both pre and post- docetaxel, study lacked exposure to second generation androgens and hence could not assess outcomes pre or post abiraterone or enzalutamide.

The specific objective of this study is to describe and compare the clinical outcomes between treatment sequences for patients with mCRPC where 1) radium-223 is used (alone or in combination with abiraterone or enzalutamide) prior to chemotherapy versus 2) radium-223 used after chemotherapy in the treatment of mCRPC. The secondary objectives are to describe the safety patterns of docetaxel use among mCRPC patients who received chemotherapy post radium-223.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-04
• Study First Submitted QC: 2018-01-26
• Study First Posted: 2018-02-05
• Study Start: 2018-12-03
• Primary Completion: 2019-10-22
• Study Completion: 2019-10-22
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-20
• Last Update Posted: 2020-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 150

Inclusion Criteria

• Received at least one dose of radium-223 after mCRPC diagnosis
• Received at least one prescription or dose of chemotherapy for treatment of mCRPC

Exclusion Criteria

• No documented visceral metastasis at initiation of radium-223

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ra-223 therapy before chemotherapy	Xofigo	Treatment sequence 1 will include all mCRPC patients who received Ra-223 alone or in combination with abiraterone or enzalutamide and subsequently received chemotherapy
Ra-223 therapy before chemotherapy	Taxotere	Treatment sequence 1 will include all mCRPC patients who received Ra-223 alone or in combination with abiraterone or enzalutamide and subsequently received chemotherapy
Ra-223 after chemotherapy	Xofigo	Treatment sequence 2 includes all mCRPC patients who received chemotherapy before Radium 223 therapy
Ra-223 after chemotherapy	Taxotere	Treatment sequence 2 includes all mCRPC patients who received chemotherapy before Radium 223 therapy
Ra-223 after chemotherapy	Jevtana	Treatment sequence 2 includes all mCRPC patients who received chemotherapy before Radium 223 therapy
Ra-223 therapy before chemotherapy	Jevtana	Treatment sequence 1 will include all mCRPC patients who received Ra-223 alone or in combination with abiraterone or enzalutamide and subsequently received chemotherapy

Primary Outcome Measures

Name	Time	Method
Time to symtomatic skeletal event(SSE)	Up to 30 months	Measured as the time from initiation of first-line therapy after mCRPC diagnosis until first SSE; for the exploratory analysis, measured as the time from initiation of radium-223 until first SSE. SSE will be identified based on the ALSYMPCA trial definition: first use of external-beam radiation therapy (EBRT) to relieve skeletal symptoms, new symptomatic pathologic vertebral or non-vertebral bone fractures, spinal cord compression, or tumor-related orthopedic surgical intervention
Reasons for treatment discontinuation	Up to 30 months	data for treatment discontinuation for each mCRPC therapy will be collected
Overall survival	Up to 30 months	Survival will be measured from initiation of first line therapy after mCRPC diagnosis until the date of death (from any cause).

Secondary Outcome Measures

Name	Time	Method
Number of hospitalizations	Up to 30 months	along with the discharge diagnosis, as recorded in medical charts or discharge summaries
PSA PFS	Up to 30 months	defined as death or an increase above PSA nadir by ≥25% and ≥2 ng/mL (PCWG 2008 definition for Prostate specific antigen(PSA) Progression-free survival(PFS))
Non-laboratory based clinically relevant safety outcomes	Up to 30 months	documented in medical records
Laboratory-based outcomes collected by questionnaire	Up to 30 months	Data will be collected as available from initiation of docetaxel until 3 months following last dose of docetaxel
Treatments received	Up to 30 months	measured as Yes/No
hospital length of stay	Up to 30 months

Trial Locations

Locations (1)

Bayer US; 🇺🇸 Whippany, New Jersey, United States