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

NCT05301062 — Terminated, 8 participants, Bayer

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China Radium-223 Safety and Effectiveness stuDy In Real World mCRPC paTients

Registry	NCT05301062, acronym CREDIT
Status	Terminated - 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.
Study type	Observational
Enrollment	8 (Actual)
Sponsor	Bayer (Industry)
Conditions	Metastatic Castration-resistant Prostate Cancer, Bone Metastases
Interventions	Radium-223 dichloride (Xofigo, BAY88-8223) (Drug)
Dates	start 2022-09-15, primary completion 2023-04-28, completion 2023-06-30, first posted 2022-03-29, last updated 2023-09-22
Locations	1 site in China

-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. 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.

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+Arms and interventions

Arm	Type	Interventions	Description
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.

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

+Outcome measures

Primary outcomes

Incidence of hematological adverse events [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

Secondary outcomes

Incidence of other treatment-emergent Adverse events (AEs) and Serious Adverse Events (SAEs) [From the start of administration of Radium-223 till up to 30 days after the last Radium-223 administration]
Overall Survival (OS) [From the start of administration of Radium-223 till patient death due to any causes. Up to 30 months]
Change in pain severity [From the start of administration of Radium-223 till up to 6 months after the last Radium-223 administration]: 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.
Time interval from the last administration of Radium-223 to the initiation date of next anti-cancer therapy [From the last administration of Radium-223 till up to 6 months]

+Eligibility

Sex: Male

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

+Locations (1)

Facility	City	Country	Status
Many locations	Multiple Locations	China

My Notes

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