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

NCT ID: NCT03325127

Last Updated: 2018-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-30

Study Completion Date

2018-09-28

Brief Summary

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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

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Conditions

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Prostatic Neoplasms, Castration-Resistant

Keywords

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Prostate Cancer, Bone metastases, Xofigo, Zytiga, Xtandi.

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Radium-223 concomitant with Abiraterone or Enzalutamide

Approximately 150 medical charts from mCRPC patients within the network will be collected

radium Ra 223 dichloride (Xofigo, BAY88-8223)

Intervention Type DRUG

Radium-223, 55kBq (1.49 microcurie) per kg body weight given at 4 week intervals for 6 injections

Zytiga

Intervention Type DRUG

Abiraterone 1000 mg per day orally

Xtandi

Intervention Type DRUG

Enzalutamide 160 mg per day orally

Interventions

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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

Intervention Type DRUG

Zytiga

Abiraterone 1000 mg per day orally

Intervention Type DRUG

Xtandi

Enzalutamide 160 mg per day orally

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Countries

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United States

Other Identifiers

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19706

Identifier Type: -

Identifier Source: org_study_id