Outcomes of mCRPC Patients Treated With Ra-223 Concomitant With Abiraterone or Enzalutamide- A Chart Review Study
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Prostate Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 40 - Any |
| Updated: | 9/14/2018 |
| Start Date: | October 20, 2017 |
| End Date: | September 28, 2018 |
Outcomes and Treatment Patterns of Metastatic Castration Resistant Prostate Cancer (mCRPC) Patients Treated With Radium-223 Concomitantly With Abiraterone or Enzalutamide in First Line Setting : A Retrospective Chart Abstraction Study
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.
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.
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
We found this trial at
1
site
Click here to add this to my saved trials
