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Drug Use Investigation of Xofigo, Castration Resistant Prostate Cancer With Bone Metastases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02803437
Recruitment Status : Active, not recruiting
First Posted : June 17, 2016
Last Update Posted : August 15, 2019
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
This study is a Japanese post-marketing surveillance (PMS) which is required by the regulatory authorities. General objective of PMS is to confirm the clinical usefulness, especially the safety profile of a drug under the routine clinical practice.

Condition or disease Intervention/treatment
Prostatic Neoplasms, Castration-Resistant Drug: Radium-223 dichloride (Xofigo, BAY 88-8223)

Detailed Description:

This is a local, non-interventional, multi-center, single-cohort study using primary data of patients treated with Xofigo for the indication of castration resistant prostate cancer (CRPC) with bone metastases. A total of 300 patients (valid for safety analysis) are enrolled within 18 months.

During the observation period (i.e. up to 6 months), safety and effectiveness information is collected. Since patient's visit occurs under the routine clinical practice, the study protocol does not define exact referral dates for those visits. The physician records patient data as defined in the protocol.

The extended follow-up period is to collect bone fractures and survival with post-treatment information after Xofigo under the real-world in Japan.

The results of this study (except of extended follow-up period) have to be submitted to the Japanese regulatory authorities as a part of the reexamination period (8 years). This study is conducted in accordance with Article 14-4 (re-examination) of the Pharmaceutical Affairs Law, and Good Post-marketing Surveillance Practice from a ministerial ordinance of Ministry of Health, Labor and Welfare in Japan.


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Study Type : Observational [Patient Registry]
Actual Enrollment : 334 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Drug Use Investigation of Xofigo, Castration Resistant Prostate Cancer With Bone Metastases
Actual Study Start Date : July 21, 2016
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : May 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Group/Cohort Intervention/treatment
Xofigo / Cohort 1
Patients suffered from CRPC with bone metastases are enrolled after the physician's decision of Xofigo treatment under the routine clinical practice.
Drug: Radium-223 dichloride (Xofigo, BAY 88-8223)
Xofigo treatment will be performed according to the product label in Japan under the routine clinical practice.




Primary Outcome Measures :
  1. Number of adverse events as a measure of safety [ Time Frame: Up to 6 months ]
    Events will be summarized by frequency tables (e.g. absolute and relative frequencies) using the MedDRA coding system

  2. Number of adverse drug reactions as a measure of safety [ Time Frame: Up to 6 months ]
    Events will be summarized by frequency tables (e.g. absolute and relative frequencies) using the MedDRA coding system


Secondary Outcome Measures :
  1. Change in laboratory findings (e.g. ALP, bone markers) [ Time Frame: From Baseline up to 6 month ]
  2. Change in analgesic use as a surrogate of pain status [ Time Frame: From Baseline up to 6 month ]
  3. Number of patients with bone fractures [ Time Frame: Up to 3 years ]
  4. Survival rate [ Time Frame: Up to 3 years ]
  5. Post-treatment information [ Time Frame: Up to 3 years ]
    Comprises information of post-treatment medication/ therapy for prostate cancer.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients suffered from castration resistant prostate cancer with bone metastases
Criteria

Inclusion Criteria:

  • Patients suffered from CRPC with bone metastases
  • Patients for whom the decision to initiate treatment with Xofigo is made as per physician's routine clinical practice.
  • Xofigo treatment naïve

Exclusion Criteria:

  • Patients treated Xofigo previously
  • Patients participating in an investigational program with interventions outside of routine clinical practice

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02803437


Locations
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Japan
Multiple Locations, Japan
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer

Additional Information:

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02803437     History of Changes
Other Study ID Numbers: 18212
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bayer:
Castration-resistant prostate cancer

Additional relevant MeSH terms:
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Prostatic Neoplasms
Prostatic Neoplasms, Castration-Resistant
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Radium Ra 223 dichloride
Antineoplastic Agents