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

• ClinicalTrials.gov Identifier: NCT02803437
• Recruitment Status: Active, not recruiting
• First Posted: June 17, 2016
• Last Update Posted: March 6, 2023
• Sponsor: Bayer
• Information provided by (Responsible Party): Bayer

Study Description

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.

Study Design

• 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
• Actual Primary Completion Date: January 6, 2022
• Estimated Study Completion Date: December 31, 2024

Groups and Cohorts

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.

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

Japan

Multiple Locations, Japan

Sponsors and Collaborators

Bayer

Investigators

• Study Director: Bayer Study Director; Bayer

More Information

Additional Information:

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• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT02803437
• Other Study ID Numbers: 18212
• First Posted: June 17, 2016
• Last Update Posted: March 6, 2023
• Last Verified: March 2023

• 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:

Prostatic Neoplasms; Prostatic Neoplasms, Castration-Resistant; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Prostatic Diseases; Radium Ra 223 dichloride; Antineoplastic Agents