MedTrace Logo

Multi-academic Center Study of Xofigo Patients

NCT03419442 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2020-10-22

No results posted yet for this study

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.

Conditions

  • Prostate Cancer, Castration Resistant

Interventions

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

Sponsors & Collaborators

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-03
Primary Completion
2019-10-22
Completion
2019-10-22

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03419442 on ClinicalTrials.gov