Multi-academic Center Study of Xofigo Patients

A Retrospective, Longitudinal Multi-Center Study of Radium-223 in Patients With Metastatic Castration-Resistant Prostate Cancer

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer, Castration Resistant
• Intervention / Treatment: Drug: Xofigo; Drug: Taxotere; Drug: Jevtana

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Whippany, New Jersey, United States, 07981
      • Bayer US

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Probability Sample

Study Population

The study population will be comprised of patients with CRPC and bone metastasis who have received at least one dose of radium-223 at one of the participating cancer centers. The participating centers are 4 tertiary care cancer centers (Dana Farber Cancer Institute, Tulane Cancer Center, Memorial Sloan Kettering Cancer Center and Beth Israel Deaconess Medical Center)

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ra-223 therapy before chemotherapy; Treatment sequence 1 will include all mCRPC patients who received Ra-223 alone or in combination with abiraterone or enzalutamide and subsequently received chemotherapy	Drug: Xofigo; Radium-223, 55kBq (1.49 microcurie) per kg body weight given at 4 week intervals for 6 injection; Drug: Taxotere; Docetaxel injection 75mg/m2 every 3 weeks; Drug: Jevtana; Cabazitaxel injection 25mg/m2 intravenously once every 3 weeks
Ra-223 after chemotherapy; Treatment sequence 2 includes all mCRPC patients who received chemotherapy before Radium 223 therapy	Drug: Xofigo; Radium-223, 55kBq (1.49 microcurie) per kg body weight given at 4 week intervals for 6 injection; Drug: Taxotere; Docetaxel injection 75mg/m2 every 3 weeks; Drug: Jevtana; Cabazitaxel injection 25mg/m2 intravenously once every 3 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival	Survival will be measured from initiation of first line therapy after mCRPC diagnosis until the date of death (from any cause).	Up to 30 months
Time to symtomatic skeletal event(SSE)	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	Up to 30 months
Reasons for treatment discontinuation	data for treatment discontinuation for each mCRPC therapy will be collected	Up to 30 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Laboratory-based outcomes collected by questionnaire	Data will be collected as available from initiation of docetaxel until 3 months following last dose of docetaxel	Up to 30 months
Treatments received	measured as Yes/No	Up to 30 months
Number of hospitalizations	along with the discharge diagnosis, as recorded in medical charts or discharge summaries	Up to 30 months
PSA PFS	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))	Up to 30 months
Non-laboratory based clinically relevant safety outcomes	documented in medical records	Up to 30 months
hospital length of stay		Up to 30 months

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here to find results for studies related to Bayer products

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 3, 2018
• Primary Completion (ACTUAL): October 22, 2019
• Study Completion (ACTUAL): October 22, 2019

Study Registration Dates

• First Submitted: January 4, 2018
• First Submitted That Met QC Criteria: January 26, 2018
• First Posted (ACTUAL): February 5, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 22, 2020
• Last Update Submitted That Met QC Criteria: October 20, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Prostate cancer; Bone metastases; Xofigo
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel
• Other Study ID Numbers: 19863

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No