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

Withdrawn

• Conditions: Prostatic Neoplasms, Castration-Resistant
• Interventions: Drug: radium Ra 223 dichloride (Xofigo, BAY88-8223); Drug: Zytiga; Drug: Xtandi

• Registration Number: NCT03325127
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2017-10-20
• Study First Submitted QC: 2017-10-27
• Study Start: 2017-10-30
• Study First Posted: 2017-10-30
• Primary Completion: 2018-09-28
• Study Completion: 2018-09-28
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-29
• Last Update Posted: 2018-10-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

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)

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Radium-223 concomitant with Abiraterone or Enzalutamide	Xtandi	Approximately 150 medical charts from mCRPC patients within the network will be collected
Radium-223 concomitant with Abiraterone or Enzalutamide	radium Ra 223 dichloride (Xofigo, BAY88-8223)	Approximately 150 medical charts from mCRPC patients within the network will be collected
Radium-223 concomitant with Abiraterone or Enzalutamide	Zytiga	Approximately 150 medical charts from mCRPC patients within the network will be collected

Primary Outcome Measures

Name	Time	Method
Survival rates	Up to 1 year	Survival will be defined as time from initiation of first line therapy until death. Survival will be measured as the proportion of study subjects that are alive at the data cut-off or median time for survival of at least 50% of study subjects

Secondary Outcome Measures

Name	Time	Method
Sequence of treatment regimens	Up to 1 year
Dose schedule	Up to 1 year
Time to first visceral metastasis	Up to 1 year
Proportion of patients developing visceral metastasis	Up to 1 year
Disease progression	Up to 1 year	Disease progression will be defined as either of the below: PSA (Prostate Specific Antigen) progression ALP (Alkaline Phosphatase) progression Symptomatic progression Radiographic progression
Skeletal related events (SRE)	Up to 1 year	SRE will be defined as: a pathologic fracture, spinal cord compression, necessity for radiation to bone for pain or impending fracture and/or surgery to bone
Symptomatic Skeletal Events (SSE)	Up to 1 year	SSE defined as external beam radiation therapy (EBRT) to relieve skeletal symptoms, new symptomatic pathologic bone fracture, occurrence of spinal cord compression, or tumor-related orthopedic surgical intervention
Time to death	Up to 1 year
Duration of therapy	Up to 1 year