Status:
WITHDRAWN
Outcomes of mCRPC Patients Treated With Ra-223 Concomitant With Abiraterone or Enzalutamide- A Chart Review Study
Lead Sponsor:
Bayer
Conditions:
Prostatic Neoplasms, Castration-Resistant
Eligibility:
MALE
40+ years
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 30 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 28 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03325127
Start Date
October 30 2017
End Date
September 28 2018
Last Update
October 31 2018
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