Clinical trial NCT05301062: 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
Official title: China Radium-223 Safety and Effectiveness stuDy In Real World mCRPC paTients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Metastatic Castration-resistant Prostate Cancer
Bone Metastases
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2022-03-29
Enrollment: 8
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Incidence of hematological adverse events
timeFrame: From the start of administration of Radium-223 till up to 6 months after the last Radium-223 administration
Secondary outcomes:
measure: Incidence of other treatment-emergent Adverse events (AEs) and Serious Adverse Events (SAEs)
timeFrame: From the start of administration of Radium-223 till up to 30 days after the last Radium-223 administration
measure: Overall Survival (OS)
timeFrame: From the start of administration of Radium-223 till patient death due to any causes. Up to 30 months
measure: Change in pain severity
timeFrame: From the start of administration of Radium-223 till up to 6 months after the last Radium-223 administration
measure: Time interval from the last administration of Radium-223 to the initiation date of next anti-cancer therapy
timeFrame: From the last administration of Radium-223 till up to 6 months
Other outcomes:
Locations:
city: Multiple Locations
country: China
facility: Many locations
Study officials:
References: