Clinical trial NCT03325127: Outcomes of mCRPC Patients Treated With Ra-223 Concomitant With Abiraterone or Enzalutamide- A Chart Review Study
Official title: 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
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Prostatic Neoplasms, Castration-Resistant
Keywords: Prostate Cancer, Bone metastases, Xofigo, Zytiga, Xtandi.
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2017-10-30
Enrollment: 0
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients will be identified by their treating physicians (oncologists and urologists), who will be recruited for participation in the research from the Cardinal Health Oncology Research Network (CHORN).

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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Survival rates
timeFrame: Up to 1 year
Secondary outcomes:
measure: Disease progression
timeFrame: Up to 1 year
measure: Skeletal related events (SRE)
timeFrame: Up to 1 year
measure: Symptomatic Skeletal Events (SSE)
timeFrame: Up to 1 year
measure: Time to death
timeFrame: Up to 1 year
measure: Sequence of treatment regimens
timeFrame: Up to 1 year
measure: Dose schedule
timeFrame: Up to 1 year
measure: Duration of therapy
timeFrame: Up to 1 year
measure: Time to first visceral metastasis
timeFrame: Up to 1 year
measure: Proportion of patients developing visceral metastasis
timeFrame: Up to 1 year
Other outcomes:
Locations:
Study officials:
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