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Outcomes of mCRPC Patients Treated With Ra-223 Concomitant With Abiraterone or Enzalutamide- A Chart Review Study

NCT03325127 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2018-10-31

No results posted yet for this study

Summary

There are no real-world data that describes how Radium-223 (Ra-223) is being used in combination with abiraterone/enzalutamide (abi/enza) or evidence describing outcomes of this combination usage for the treatment of metastatic castration resistant prostate cancer (mCRPC). To address these data gaps a cohort of mCRPC patients will be chosen who received Ra-223 concomitant with abi/enza in first line therapy to assess the treatment patterns following first line and clinical outcomes from initiation of first line treatment. For the purpose of this study concomitant use will be defined as Ra-223 initiated after at least 6 months from the start of first line abi/enza. The specific objectives of the study are to describe the outcomes, treatment patterns, patient and provider characteristics of mCRPC patients treated with Ra-223 concomittantly with abi/enza in first line treatment.

Conditions

  • Prostatic Neoplasms, Castration-Resistant

Interventions

DRUG

radium Ra 223 dichloride (Xofigo, BAY88-8223)

Radium-223, 55kBq (1.49 microcurie) per kg body weight given at 4 week intervals for 6 injections

DRUG

Zytiga

Abiraterone 1000 mg per day orally

DRUG

Xtandi

Enzalutamide 160 mg per day orally

Sponsors & Collaborators

Eligibility

Min Age
40 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-30
Primary Completion
2018-09-28
Completion
2018-09-28

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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 NCT03325127 on ClinicalTrials.gov