Prostatic Neoplasms, Castration-ResistantNCT02803437
Drug Use Investigation of Xofigo, Castration Resistant Prostate Cancer With Bone Metastases
An observational study of Prostatic Neoplasms, Castration-Resistant, run by Bayer at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostatic Neoplasms, Castration-Resistant
- What is being tested?
- Radium-223 dichloride (Xofigo, BAY 88-8223)
- How many people
- 334 participants
- Where
- 1 siteJapan
- Study dates
- 21 Jul 2016to 18 Dec 2024
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients suffered from castration resistant prostate cancer with bone metastases
Who may be able to join
- 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
Who cannot join
- Patients treated Xofigo previously
- Patients participating in an investigational program with interventions outside of routine clinical practice
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Radium-223 dichloride (Xofigo, BAY 88-8223)
- Keywords
- Castration-resistant prostate cancer
- Medical subject headings
- Prostatic Neoplasms, Castration-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radium-223 dichloride (Xofigo, BAY 88-8223)Drug
Xofigo treatment will be performed according to the product label in Japan under the routine clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Radium-223 dichloride (Xofigo, BAY 88-8223) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events as a measure of safety
Events will be summarized by frequency tables (e.g. absolute and relative frequencies) using the MedDRA coding system
Measured: Up to 6 months
Number of adverse drug reactions as a measure of safety
Events will be summarized by frequency tables (e.g. absolute and relative frequencies) using the MedDRA coding system
Measured: Up to 6 months
Secondary outcomes (5)
Change in laboratory findings (e.g. ALP, bone markers)
Measured: From Baseline up to 6 month
Change in analgesic use as a surrogate of pain status
Measured: From Baseline up to 6 month
Number of patients with bone fractures
Measured: Up to 3 years
Survival rate
Measured: Up to 3 years
Post-treatment information
Comprises information of post-treatment medication/ therapy for prostate cancer
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study start21 Jul 2016
- Primary completion6 Jan 2022
- Study completion18 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Prostatic Neoplasms, Castration-ResistantStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 334 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02803437
- Sponsor's protocol ID
- 18212
- Status last verified
- Jul 2025
- First submitted
- 14 Jun 2016
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hosono M, Uemura H, Kakehi Y, Masumori N, Takahashi S, Okayama Y, Sunaya T, Horio T, Kinuya S. [Exploratory Analysis Results from Post-marketing Surveillance Study of Radium-223 in Japanese Patients with Castration-resistant Prostate Cancer and Bone Metastases: Subgroup Analysis by Age]. Kaku Igaku. 2021;58(1):91-101. doi: 10.18893/kakuigaku.oa.2105. Japanese.
PubMed 34645727Uemura H, Masumori N, Takahashi S, Hosono M, Kinuya S, Sunaya T, Horio T, Okayama Y, Kakehi Y. Real-world safety and effectiveness of radium-223 in Japanese patients with castration-resistant prostate cancer (CRPC) and bone metastasis: exploratory analysis, based on the results of post-marketing surveillance, according to prior chemotherapy status and in patients without concomitant use of second-generation androgen-receptor axis-targeted agents. Int J Clin Oncol. 2021 Apr;26(4):753-763. doi: 10.1007/s10147-020-01850-3. Epub 2021 Feb 11.
PubMed 33575828Masumori N, Kakehi Y, Hosono M, Kinuya S, Takahashi S, Okayama Y, Sunaya T, Horio T, Uemura H (2020) Post-marketing Surveillance （PMS） Study for Safety and Effectiveness of Radium-223 in Japanese Patients with CRPC and Bone Metastases in Real-world Settings: Exploratory Analysis on Treatment Completion of Six Cycles of Radium-223 and Discontinuation. Medical Consultation & New Remedies 57:705-717
Takahashi S, Uemura H, Masumori N, Kinuya S, Hosono M, Okayama Y, Sunaya T, Horio T, Kakehi Y (2020) Safety and effectiveness of radium-223 in Japanese patients with CRPC and bone metastases in real world-settings: The results of post-marketing surveillance (PMS). Japanese Journal of Urological Surgery 33(4):435-449
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Use Investigation of Xofigo, Castration Resistant Prostate Cancer With Bone Metastases
- ClinicalTrials.gov ID
- NCT02803437
- Acronym / sponsor ID
- 18212
- Keywords
- Castration-resistant prostate cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 334 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 21 Jul 2016 (actual)
- Primary completion
- 6 Jan 2022 (actual)
- Study completion
- 18 Dec 2024 (actual)
- First posted
- 17 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Xofigo / Cohort 1 | – | Drug: Radium-223 dichloride (Xofigo, BAY 88-8223)Patients suffered from CRPC with bone metastases are enrolled after the physician's decision of Xofigo treatment under the routine clinical practice. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients suffered from castration resistant prostate cancer with bone metastases
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Patients treated Xofigo previously
- Patients participating in an investigational program with interventions outside of routine clinical practice
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radium-223 dichloride (Xofigo, BAY 88-8223)Xofigo treatment will be performed according to the product label in Japan under the routine clinical practice. | Drug | Xofigo / Cohort 1 |
Primary outcome
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
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
5 secondary outcomes
Change in laboratory findings (e.g. ALP, bone markers)
Time frame: From Baseline up to 6 month
Change in analgesic use as a surrogate of pain status
Time frame: From Baseline up to 6 month
Number of patients with bone fractures
Time frame: Up to 3 years
Survival rate
Time frame: Up to 3 years
Post-treatment information
Time frame: Up to 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
- Results publication: PubMed 34645727Hosono M, Uemura H, Kakehi Y, Masumori N, Takahashi S, Okayama Y, Sunaya T, Horio T, Kinuya S. [Exploratory Analysis Results from Post-marketing Surveillance Study of Radium-223 in Japanese Patients with Castration-resistant Prostate Cancer and Bone Metastases: Subgroup Analysis by Age]. Kaku Igaku. 2021;58(1):91-101. doi: 10.18893/kakuigaku.oa.2105. Japanese.
- Results publication: PubMed 33575828Uemura H, Masumori N, Takahashi S, Hosono M, Kinuya S, Sunaya T, Horio T, Okayama Y, Kakehi Y. Real-world safety and effectiveness of radium-223 in Japanese patients with castration-resistant prostate cancer (CRPC) and bone metastasis: exploratory analysis, based on the results of post-marketing surveillance, according to prior chemotherapy status and in patients without concomitant use of second-generation androgen-receptor axis-targeted agents. Int J Clin Oncol. 2021 Apr;26(4):753-763. doi: 10.1007/s10147-020-01850-3. Epub 2021 Feb 11.
- Results publicationMasumori N, Kakehi Y, Hosono M, Kinuya S, Takahashi S, Okayama Y, Sunaya T, Horio T, Uemura H (2020) Post-marketing Surveillance （PMS） Study for Safety and Effectiveness of Radium-223 in Japanese Patients with CRPC and Bone Metastases in Real-world Settings: Exploratory Analysis on Treatment Completion of Six Cycles of Radium-223 and Discontinuation. Medical Consultation & New Remedies 57:705-717
- Results publicationTakahashi S, Uemura H, Masumori N, Kinuya S, Hosono M, Okayama Y, Sunaya T, Horio T, Kakehi Y (2020) Safety and effectiveness of radium-223 in Japanese patients with CRPC and bone metastases in real world-settings: The results of post-marketing surveillance (PMS). Japanese Journal of Urological Surgery 33(4):435-449
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostatic Neoplasms, Castration-Resistant, run by Bayer at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of adverse events as a measure of safety (time frame: Up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02803437, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2025.