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Multi-academic Center Study of Xofigo Patients

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Bayer

Status

Completed

Conditions

Prostate Cancer, Castration Resistant

Treatments

Drug: Taxotere
Drug: Xofigo
Drug: Jevtana

Study type

Observational

Funder types

Industry

Identifiers

Details and patient eligibility

About

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.

Enrollment

150 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

150 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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