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

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.

Study Overview

• Status: Withdrawn
• Conditions: Prostatic Neoplasms, Castration-Resistant
• Intervention / Treatment: Drug: radium Ra 223 dichloride (Xofigo, BAY88-8223); Drug: Zytiga; Drug: Xtandi

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• 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).

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Radium-223 concomitant with Abiraterone or Enzalutamide; Approximately 150 medical charts from mCRPC patients within the network will be collected	Drug: radium Ra 223 dichloride (Xofigo, BAY88-8223); Radium-223, 55kBq (1.49 microcurie) per kg body weight given at 4 week intervals for 6 injections; Drug: Zytiga; Abiraterone 1000 mg per day orally; Drug: Xtandi; Enzalutamide 160 mg per day orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival rates	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	Up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease progression	Disease progression will be defined as either of the below: PSA (Prostate Specific Antigen) progression ALP (Alkaline Phosphatase) progression Symptomatic progression Radiographic progression	Up to 1 year
Skeletal related events (SRE)	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	Up to 1 year
Symptomatic Skeletal Events (SSE)	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	Up to 1 year
Time to death		Up to 1 year
Sequence of treatment regimens		Up to 1 year
Dose schedule		Up to 1 year
Duration of therapy		Up to 1 year
Time to first visceral metastasis		Up to 1 year
Proportion of patients developing visceral metastasis		Up to 1 year

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Anticipated): October 30, 2017
• Primary Completion (Anticipated): September 28, 2018
• Study Completion (Anticipated): September 28, 2018

Study Registration Dates

• First Submitted: October 20, 2017
• First Submitted That Met QC Criteria: October 27, 2017
• First Posted (Actual): October 30, 2017

Study Record Updates

• Last Update Posted (Actual): October 31, 2018
• Last Update Submitted That Met QC Criteria: October 29, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Prostate Cancer, Bone metastases, Xofigo, Zytiga, Xtandi.
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Prostatic Neoplasms, Castration-Resistant; Antineoplastic Agents; Radium Ra 223 dichloride
• Other Study ID Numbers: 19706

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No