Descriptive Analysis of Clinical Outcomes in Patients With Prostate Gland Cancer, Which Spreads to Other Parts of the Body, Who Were Treated First With Novel Anti-hormone Therapy Followed by a Second Line Treatment With Novel Anti-Hormone Therapy or RadIum-223 (Xofigo). (PHENIX)

Bayer

Status: Completed

Conditions: Metastatic Castration-resistant Prostate Cancer (mCRPC)

Treatments: Drug: Radium-223 (Xofigo, BAY88-8223); Drug: Enzalutamide; Drug: Abiraterone

Study type: Observational

Funder types: Industry

Identifiers

NCT03896984

20526

Details and patient eligibility

About

In this study researcher want to learn more about the overall survival in patients suffering from prostate gland cancer which spread outside the prostate to other parts of the body who received either a novel anti-hormone therapy (NAH) or Radium-223 (Xofigo) after a prior NAH therapy (first line treatment). Additionally the researchers are also interested in the occurrence of bone fractures and other skeletal events. Basis for this study will be the US based Flatiron database which provides access to clinical data for cancer patients.

Enrollment: 346 patients

Sex: Male

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with documented mCRPC receiving 1L NAHs.
• Initiation of Ra-223 after 1L NAH therapy, or
• Initiation of sequential NAH therapy after 1L NAH therapy

Exclusion criteria

• Patients involved in clinical trials
• Patients who received combined therapies in 1L or 2L

Trial design

346 participants in 2 patient groups

Cohort_2LX

Description:

Patients with mCRPC who received NAH monotherapy (Abiraterone or Enzalutamide) as first liine (1L) after diagnosis of mCRPC who then received Ra-223 monotherapy as second line (2L) treatment

Treatment:

Drug: Abiraterone

Drug: Enzalutamide

Drug: Radium-223 (Xofigo, BAY88-8223)

Cohort_2LH

Description:

Patients with mCRPC who received NAH monotherapy (Abiraterone or Enzalutamide) as 1L after diagnosis of mCRPC who then received another NAH monotherapy (i.e., Abiraterone to Enzalutamide or Enzalutamide to Abiraterone) as 2L treatment. None of the patients had ever received Radium-223 dichloride

Treatment:

Drug: Abiraterone

Drug: Enzalutamide