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

Bayer

Status

Withdrawn

Conditions

Prostatic Neoplasms, Castration-Resistant

Treatments

Drug: Zytiga

Drug: radium Ra 223 dichloride (Xofigo, BAY88-8223)

Drug: Xtandi

Study type

Observational

Funder types

Industry

Identifiers

NCT03325127

19706

Details and patient eligibility

About

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.

Sex

Male

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosis of mCRPC and bone metastases
≥ 40 years of age at diagnosis of mCRPC
Initiated first line treatment for mCRPC with abi/enza (use of sipuleucel-T prior to initiation of abi or enza is allowed)
Receipt of at least one cycle of radium-223 after 15 May 2013
First cycle of Ra-223 occurs while receiving first line treatment with abi/enza
Treated with abi/enza for at least 28 days (1 cycle) following initiation of Ra-223
Initiation of Ra-223 at least 6 months after the start of treatment with abi/enza
Completion of Ra-223 treatment prior to the receipt of any chemotherapy for mCRPC
At least 12 months of follow-up (or until death) from date of initiation of Ra-223
Known date of death (if patient deceased)

Exclusion criteria

Receipt of any prior chemotherapy during hormone sensitive disease or any time before mCPRC
Active participant in an interventional clinical trial for CRPC in first line
Presence of visceral metastases at initiation of Ra-223 treatment
Treated with abi/enza (with or without docetaxel) prior to the development of metastatic and/or castration resistant disease