Metastatic Castration-resistant Prostate CancerCREDITNCT05301062
A Research Called CREDIT Studies How Safe the Study Treatment Radium-223 is and How Well it Works in Chinese Men With Advanced Prostate Cancer That Has Spread to the Bones and Does Not Respond to Treatments for Lowering Testosterone Levels
An observational study of Metastatic Castration-resistant Prostate Cancer and Bone Metastases, run by Bayer at 1 site in China.
Trial summary
This is an observational study in which data from Chinese men with metastatic castration-resistant prostate cancer that has spread to the bones and who start Radium-223 therapy is studied. When tumors form in the prostate, male hormones like testosterone will cause the spread and growth of tumors. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Metastatic Castration-resistant Prostate Cancer, Bone Metastases
- What is being tested?
- Radium-223 dichloride (Xofigo, BAY88-8223)
- How many people
- 8 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2022to 30 Jun 2023
- 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: The study population will consist of CRPC patients with bone metastases treated with Radium-223. Treating physicians (medical oncologists, urologists, nuclear medicine physicians) or designated medical persons will collect historic records and on-study data from the medical records, routine measurements (e.g. tumor assessment). Radium-223 administering physicians in certain circumstances may also collect information including dosing data and other related data from similar sources.
Who may be able to join
- Male patient
- Histologically or cytologically confirmed castration resistant adenocarcinoma of the prostate with bone metastases
- No visceral metastases
- Decision to initiate treatment with Radium-223 was made independently prior to patient enrollment in the study as per investigator's routine treatment practice
- Signed informed consent
Who cannot join
- Patients previously treated with Radium-223 for any reason
- Patients currently treated in any other clinical trials including other Radium-223 studies
- Patients are planned for the systemic concomitant use of other radiopharmaceuticals for treatment of prostate cancer or for other use
- Participation in an investigational program with interventions outside of routine clinical practice
- Patients previously treated with Docetaxel
- Patients under treatment with Abiraterone Acetate and the Corticosteroids Prednisone or Prednisolone
- Besides Inclusion and exclusion criteria, sites should also follow the locally approved Radium-223 product information
Trial locations and contacts
1 site in 1 country.
About this study
Official title: China Radium-223 Safety and Effectiveness stuDy In Real World mCRPC paTients
This is an observational study in which data from Chinese men with metastatic castration-resistant prostate cancer that has spread to the bones and who start Radium-223 therapy is studied.
When tumors form in the prostate, male hormones like testosterone will cause the spread and growth of tumors. Men with prostate cancer can have hormonal or surgical treatment that lowers testosterone. But this may not stop the cancer from growing or spreading in some men. When the prostate cancer is no longer responding to therapies aimed at lowering testosterone (castration resistant) and has spread to the bones (metastatic), it is referred to as bone metastatic castration-resistant prostate cancer.
Read more
The study treatment, Radium-223 (also called Xofigo), gives off radiation that helps to kill cancer cells. It is already approved to be used for men whose prostate cancer has spread to the bone with symptoms, but not to be used for other types of tumors or for prostate cancer that has spread to other parts of the body. Sometimes, after the approval of some drugs, researchers will further study the safety of such approved treatments in patients being treated in routine clinical practice.
In this study, researchers want to learn more about the medical problems that may occur in Chinese patients after they start Radium-223 therapy, especially those problems concerning the blood and blood-forming organs. To answer this question, the researchers will observe patients who start Radium-223 as part of their routine care and also collect information of any medical problems happening after Radium-223 injections from the medical records of these patients. These medical problems may or may not be related to Radium-223 and are also known as adverse events.
The researchers will assess the percentage of men who developed medical problems concerning the blood and blood-forming organs from the start of Radium-223 injection till up to 6 months after the last Radium-223 injection.
The researchers will also collect data on the time the participants live after start of treatment, the change in pain severity, and the time between the end of Radium-223 treatment and the beginning of the following therapy against the cancer.
Besides the data collection, no further tests or examinations of any patients or any samples are planned in this study. The participants will start Radium-223 treatment as part of their routine care as prescribed by their doctors according to the recommended use. Data collection of each participant will last until the participant leaves the study or until the study ends. The study is planned to end 6 months after the last included participant receives the last injection of Radium-223.
- Being tested
- Radium-223 dichloride (Xofigo, BAY88-8223)
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
Treatment with Radium-223 should follow the approved local product information according to National Medical Products Administration (NMPA) approved label
| Study group | Role | What they receive |
|---|---|---|
| Radium-223 dichloride treatment | Castration-resistant prostate cancer (CRPC) patients with bone metastases for whom a decision has been made independently by the treating physician and the patient to treat with Radium-223. 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 hematological adverse events
Hematological adverse events are reported as bone marrow suppression
Measured: From the start of administration of Radium-223 till up to 6 months after the last Radium-223 administration
Secondary outcomes (4)
Incidence of other treatment-emergent Adverse events (AEs) and Serious Adverse Events (SAEs)
Measured: From the start of administration of Radium-223 till up to 30 days after the last Radium-223 administration
Overall Survival (OS)
Measured: From the start of administration of Radium-223 till patient death due to any causes. Up to 30 months
Change in pain severity
Pain severity will be measured using the worst pain score from the Brief pain inventory short form (BPI-SF) questionnaire. The BPI-SF is a self-administered questionnaire with 11 items designed to evaluate the intensity of, and the impairment caused by pain. Four items measure pain intensity using 0 ("no pain") to 10 ("pain as bad as you can imagine") numeric rating scales, and 7 items measure the level of interference with function caused by pain using 0 (no interference) to 10 (complete interference) rating scales.
Measured: From the start of administration of Radium-223 till up to 6 months after the last Radium-223 administration
Time interval from the last administration of Radium-223 to the initiation date of next anti-cancer therapy
Measured: From the last administration of Radium-223 till up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start15 Sep 2022
- Primary completion28 Apr 2023
- Study completion30 Jun 2023
Why it stopped: Due to the changes of standard of care, the slow recruitment of participants, and the similar safety profile data on real-world use of Radium-223 in China has been published.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic 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
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05301062
- Sponsor's protocol ID
- 21720
- Acronym
- CREDIT
- Status last verified
- Sep 2023
- First submitted
- 21 Mar 2022
- Last updated
- 22 Sep 2023
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- China Radium-223 Safety and Effectiveness stuDy In Real World mCRPC paTients
- ClinicalTrials.gov ID
- NCT05301062
- Acronym / sponsor ID
- CREDIT / 21720
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Due to the changes of standard of care, the slow recruitment of participants, and the similar safety profile data on real-world use of Radium-223 in China has been published.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 28 Apr 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 29 Mar 2022 (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.
This is an observational study in which data from Chinese men with metastatic castration-resistant prostate cancer that has spread to the bones and who start Radium-223 therapy is studied.
When tumors form in the prostate, male hormones like testosterone will cause the spread and growth of tumors. Men with prostate cancer can have hormonal or surgical treatment that lowers testosterone. But this may not stop the cancer from growing or spreading in some men. When the prostate cancer is no longer responding to therapies aimed at lowering testosterone (castration resistant) and has spread to the bones (metastatic), it is referred to as bone metastatic castration-resistant prostate cancer.
The study treatment, Radium-223 (also called Xofigo), gives off radiation that helps to kill cancer cells. It is already approved to be used for men whose prostate cancer has spread to the bone with symptoms, but not to be used for other types of tumors or for prostate cancer that has spread to other parts of the body. Sometimes, after the approval of some drugs, researchers will further study the safety of such approved treatments in patients being treated in routine clinical practice.
In this study, researchers want to learn more about the medical problems that may occur in Chinese patients after they start Radium-223 therapy, especially those problems concerning the blood and blood-forming organs. To answer this question, the researchers will observe patients who start Radium-223 as part of their routine care and also collect information of any medical problems happening after Radium-223 injections from the medical records of these patients. These medical problems may or may not be related to Radium-223 and are also known as adverse events.
The researchers will assess the percentage of men who developed medical problems concerning the blood and blood-forming organs from the start of Radium-223 injection till up to 6 months after the last Radium-223 injection.
The researchers will also collect data on the time the participants live after start of treatment, the change in pain severity, and the time between the end of Radium-223 treatment and the beginning of the following therapy against the cancer.
Besides the data collection, no further tests or examinations of any patients or any samples are planned in this study. The participants will start Radium-223 treatment as part of their routine care as prescribed by their doctors according to the recommended use. Data collection of each participant will last until the participant leaves the study or until the study ends. The study is planned to end 6 months after the last included participant receives the last injection of Radium-223.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radium-223 dichloride treatment | – | Drug: Radium-223 dichloride (Xofigo, BAY88-8223)Castration-resistant prostate cancer (CRPC) patients with bone metastases for whom a decision has been made independently by the treating physician and the patient to treat with Radium-223. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will consist of CRPC patients with bone metastases treated with Radium-223. Treating physicians (medical oncologists, urologists, nuclear medicine physicians) or designated medical persons will collect historic records and on-study data from the medical records, routine measurements (e.g. tumor assessment). Radium-223 administering physicians in certain circumstances may also collect information including dosing data and other related data from similar sources.
Key inclusion criteria (5 listed)
- Male patient
- Histologically or cytologically confirmed castration resistant adenocarcinoma of the prostate with bone metastases
- No visceral metastases
- Decision to initiate treatment with Radium-223 was made independently prior to patient enrollment in the study as per investigator's routine treatment practice
- Signed informed consent
Key exclusion criteria (7 listed)
- Patients previously treated with Radium-223 for any reason
- Patients currently treated in any other clinical trials including other Radium-223 studies
- Patients are planned for the systemic concomitant use of other radiopharmaceuticals for treatment of prostate cancer or for other use
- Participation in an investigational program with interventions outside of routine clinical practice
- Patients previously treated with Docetaxel
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)Treatment with Radium-223 should follow the approved local product information according to National Medical Products Administration (NMPA) approved label | Drug | Radium-223 dichloride treatment |
Primary outcome
Incidence of hematological adverse events
Time frame: From the start of administration of Radium-223 till up to 6 months after the last Radium-223 administration
Hematological adverse events are reported as bone marrow suppression
4 secondary outcomes
Incidence of other treatment-emergent Adverse events (AEs) and Serious Adverse Events (SAEs)
Time frame: From the start of administration of Radium-223 till up to 30 days after the last Radium-223 administration
Overall Survival (OS)
Time frame: From the start of administration of Radium-223 till patient death due to any causes. Up to 30 months
Change in pain severity
Time frame: From the start of administration of Radium-223 till up to 6 months after the last Radium-223 administration
Time interval from the last administration of Radium-223 to the initiation date of next anti-cancer therapy
Time frame: From the last administration of Radium-223 till up to 6 months
Results and safety
The study was stopped early (reason given: Due to the changes of standard of care, the slow recruitment of participants, and the similar safety profile data on real-world use of Radium-223 in China has been published.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- 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.
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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.
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 Metastatic Castration-resistant Prostate Cancer and Bone Metastases, run by Bayer at 1 site in China.
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 5 inclusion and 7 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: stopped early, as of the sponsor's last update on 22 Sep 2023. 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 China. 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 was stopped early (reason given: Due to the changes of standard of care, the slow recruitment of participants, and the similar safety profile data on real-world use of Radium-223 in China has been published.). Results are not available in the source record.
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 hematological adverse events (time frame: From the start of administration of Radium-223 till up to 6 months after the last Radium-223 administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Sep 2023.