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 (CREDIT)

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.

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 Overview

• Status: Terminated
• Conditions: Bone Metastases; Metastatic Castration-resistant Prostate Cancer
• Intervention / Treatment: Drug: Radium-223 dichloride (Xofigo, BAY88-8223)

• Study Type: Observational
• Enrollment (Actual): 8

Contacts and Locations

• Study Contact: Name: Bayer Clinical Trials Contact; Phone Number: (+)1-888-84 22937; Email: clinical-trials-contact@bayer.com

Study Locations

• China
  • Multiple Locations, China
    • Many Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of hematological adverse events	Hematological adverse events are reported as bone marrow suppression	From the start of administration of Radium-223 till up to 6 months after the last Radium-223 administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	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		From the last administration of Radium-223 till up to 6 months

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2022
• Primary Completion (Actual): April 28, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: March 21, 2022
• First Submitted That Met QC Criteria: March 21, 2022
• First Posted (Actual): March 29, 2022

Study Record Updates

• Last Update Posted (Actual): September 22, 2023
• Last Update Submitted That Met QC Criteria: September 21, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms; Antineoplastic Agents; Radium Ra 223 dichloride
• Other Study ID Numbers: 21720

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No