Castration-resistant Prostate CancerRAPITNCT04232761
Study to Gather Information on the Safety and How Radium-223 Dichloride, an Alpha Particle-emitting Radioactive Agent, Works Under Routine Clinical Practice in Taiwan in Patients With Castration-resistant Prostate Cancer (CRPC) Which Has Spread to the Bone
An observational study of Castration-resistant Prostate Cancer, run by Bayer at 1 site in Taiwan.
Trial summary
In this observational study researchers want to gather more information about safety and survival in patients suffering from castration-resistant prostate cancer (CRPC) which has spread to the bone and were treated with radium-223 in routine clinical practice in Taiwan. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Castration-resistant Prostate Cancer
- What is being tested?
- Radium-223 dichloride (Xofigo, BAY88-8223)
- How many people
- 194 participants
- Where
- 1 siteTaiwan
- Study dates
- 7 Jul 2020to 29 Apr 2024
- 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: Male patients in routine clinical practice from Taiwan
Who may be able to join
- Histologically or cytologically confirmed castration-resistant adenocarcinoma of the prostate with bone metastases
- Treatment decision for Radium-223 according to local label needs to be made independent from and before patient enrollment in the study by the investigator
- No contra-indications according to the local marketing authorization
Who cannot join
- Previously treated with Radium-223 for any reason
- Currently treated in clinical trials including other Radium-223 studies or planned participation in an investigational program with interventions outside of routine clinical practice during the study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Effectiveness of Xofigo® (Radium-223 Dichloride) in Routine Clinical Practice Settings in Taiwan
In this observational study researchers want to gather more information about safety and survival in patients suffering from castration-resistant prostate cancer (CRPC) which has spread to the bone and were treated with radium-223 in routine clinical practice in Taiwan. Radium-223 (Ra-223) is an alpha particle-emitting radioactive agent approved for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC).
Read the detailed description
The primary objective of the study is to describe the safety profile of radium-223 dichloride in patients having castration-resistent prostate cancer with symptomatic bone metastases and who are treated in routine clinical practice in Taiwan.
The secondary objective is to assess the effectiveness of radium-223 dichloride in these patients.
- Conditions
- Castration-resistant Prostate Cancer
- Being tested
- Radium-223 dichloride (Xofigo, BAY88-8223)
- Keywords
- Bone metastases, Radium-223 dichloride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radium-223 dichloride (Xofigo, BAY88-8223)Drug
Drug administration as determined by treating physician
| Study group | Role | What they receive |
|---|---|---|
| CRPC patients | Patients with castration-resistant prostate cancer (CRPC) and symptomatic bone metastases who are treated with radium-223 dichloride in routine clinical practice in Taiwan Receives: Drug: Radium-223 dichloride (Xofigo, BAY88-8223) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events (TEAEs)
Measured: Up to 7 months
Incidence of drug-related TEAEs
Measured: Up to 7 months
Descriptive analysis of long-term safety information during the extended follow-up period
This safety information may include e.g. hematological adverse events, bone fractures or osteoporosis.
Measured: Up to 2 years
Secondary outcomes (6)
Overall survival
Measured: Up to 2 years
Time to the first symptomatic skeletal event (SSE)
Measured: Up to 2 years
Proportion of patients with total ALP (tALP) response
ALP - Alkaline Phosphatase tALP - Total Alkaline Phosphatase
Measured: Up to 2 years
Proportion of patients with PSA response
PSA - Prostate Specific Antigen
Measured: Up to 2 years
Change in pain status
Pain status is assessed through analgesic utility that is calculated by WHO analgesic scores (0 - none, 1 - non-opioid, 2 - opioid for mild to moderate pain, 3 - opioid for moderate to severe pain)
Measured: Up to 2 years
Change in ECOG-PS
The Cooperative Oncology Group-Performance Status (ECOG-PS) score ranks the performance status from 0 (perfect health) to 5 (death).
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start7 Jul 2020
- Primary completion29 Apr 2024
- Study completion29 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Castration-resistant Prostate CancerStudies 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
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04232761
- Sponsor's protocol ID
- 21124
- Acronym
- RAPIT
- Status last verified
- Jul 2024
- First submitted
- 15 Jan 2020
- Last updated
- 17 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Publications
Huang CY, Huang CP, Huang YY, Huang SK, Lu K, Meng E, Huang SP, Lee MY, Hung SC, Chen F, Pang ST. Real-World Safety and Effectiveness of Radium-223 in Patients with Metastatic Castration-Resistant Prostate Cancer: Final Analysis of the RAPIT Study. Target Oncol. 2026 Oct 25. doi: 10.1007/s11523-026-01254-9. Online ahead of print.
PubMed 42928397Huang CY, Huang CP, Huang YY, Huang SK, Lu K, Huang WJ, Meng E, Huang SP, Lee MY, Chen F, Pang ST. Real-world safety and effectiveness of radium-223 in patients with metastatic castration-resistant prostate cancer: Interim analyses of the prospective, observational RAPIT study. Int J Cancer. 2024 Oct 1;155(7):1268-1277. doi: 10.1002/ijc.35040. Epub 2024 Jun 26.
PubMed 38924042
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of Xofigo® (Radium-223 Dichloride) in Routine Clinical Practice Settings in Taiwan
- ClinicalTrials.gov ID
- NCT04232761
- Acronym / sponsor ID
- RAPIT / 21124
- Conditions
- Castration-resistant Prostate Cancer
- Keywords
- Bone metastases, Radium-223 dichloride
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 7 Jul 2020 (actual)
- Primary completion
- 29 Apr 2024 (actual)
- Study completion
- 29 Apr 2024 (actual)
- First posted
- 18 Jan 2020 (actual)
- 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.
In this observational study researchers want to gather more information about safety and survival in patients suffering from castration-resistant prostate cancer (CRPC) which has spread to the bone and were treated with radium-223 in routine clinical practice in Taiwan. Radium-223 (Ra-223) is an alpha particle-emitting radioactive agent approved for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC).
Detailed description
The primary objective of the study is to describe the safety profile of radium-223 dichloride in patients having castration-resistent prostate cancer with symptomatic bone metastases and who are treated in routine clinical practice in Taiwan.
The secondary objective is to assess the effectiveness of radium-223 dichloride in these patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CRPC patients | – | Drug: Radium-223 dichloride (Xofigo, BAY88-8223)Patients with castration-resistant prostate cancer (CRPC) and symptomatic bone metastases who are treated with radium-223 dichloride in routine clinical practice in Taiwan |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Male patients in routine clinical practice from Taiwan
Key inclusion criteria (3 listed)
- Histologically or cytologically confirmed castration-resistant adenocarcinoma of the prostate with bone metastases
- Treatment decision for Radium-223 according to local label needs to be made independent from and before patient enrollment in the study by the investigator
- No contra-indications according to the local marketing authorization
Key exclusion criteria (2 listed)
- Previously treated with Radium-223 for any reason
- Currently treated in clinical trials including other Radium-223 studies or planned participation in an investigational program with interventions outside of routine clinical practice during the study period
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, BAY88-8223)Drug administration as determined by treating physician | Drug | CRPC patients |
Primary outcome
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: Up to 7 months
Incidence of drug-related TEAEs
Time frame: Up to 7 months
Descriptive analysis of long-term safety information during the extended follow-up period
Time frame: Up to 2 years
This safety information may include e.g. hematological adverse events, bone fractures or osteoporosis.
6 secondary outcomes
Overall survival
Time frame: Up to 2 years
Time to the first symptomatic skeletal event (SSE)
Time frame: Up to 2 years
Proportion of patients with total ALP (tALP) response
Time frame: Up to 2 years
Proportion of patients with PSA response
Time frame: Up to 2 years
Change in pain status
Time frame: Up to 2 years
Change in ECOG-PS
Time frame: Up to 2 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 17 Jul 2024.
- Derived from this study: PubMed 42928397Huang CY, Huang CP, Huang YY, Huang SK, Lu K, Meng E, Huang SP, Lee MY, Hung SC, Chen F, Pang ST. Real-World Safety and Effectiveness of Radium-223 in Patients with Metastatic Castration-Resistant Prostate Cancer: Final Analysis of the RAPIT Study. Target Oncol. 2026 Oct 25. doi: 10.1007/s11523-026-01254-9. Online ahead of print.
- Derived from this study: PubMed 38924042Huang CY, Huang CP, Huang YY, Huang SK, Lu K, Huang WJ, Meng E, Huang SP, Lee MY, Chen F, Pang ST. Real-world safety and effectiveness of radium-223 in patients with metastatic castration-resistant prostate cancer: Interim analyses of the prospective, observational RAPIT study. Int J Cancer. 2024 Oct 1;155(7):1268-1277. doi: 10.1002/ijc.35040. Epub 2024 Jun 26.
- Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Related trials for Castration-resistant Prostate Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
RecruitingPhase 2
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
Metastatic Castration-Resistant Prostate Cancer
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingObservational study
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
Prostate Cancer, Prostate Adenocarcinoma
Active, not recruitingPhase 2
FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Metastatic Castration-resistant Prostate Cancer
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Castration-resistant Prostate Cancer, run by Bayer at 1 site in Taiwan.
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 17 Jul 2024. 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 Taiwan. 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?
Incidence of treatment-emergent adverse events (TEAEs) (time frame: Up to 7 months). The study lists 3 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 NCT04232761, which also lists 2 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 17 Jul 2024.