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Metastatic castration-resistant prostate cancer, Bone metastases

Bayer Identifier:

21720

ClinicalTrials.gov Identifier:

NCT05301062

EudraCT Number:

Not Available

EU CT Number:

Not Available
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

Trial purpose

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.

Key Participants Requirements

Sex

Male

Age

NaN - N/A
  • - 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
  • - 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 summary

Enrollment Goal
8
Trial Dates
September 2022 - June 2023
Phase
Phase 4
Could I Receive a placebo
No
Products
Xofigo (Radium-223 dichloride, BAY88-8223)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Recruiting
Many locationsMany locations, China

Primary Outcome

  • Incidence of hematological adverse events
    Hematological adverse events are reported as bone marrow suppression
    date_rangeTime Frame:
    From the start of administration of Radium-223 till up to 6 months after the last Radium-223 administration

Secondary Outcome

  • Incidence of other treatment-emergent Adverse events (AEs) and Serious Adverse Events (SAEs)
    date_rangeTime Frame:
    From the start of administration of Radium-223 till up to 30 days after the last Radium-223 administration
  • Overall Survival (OS)
    date_rangeTime Frame:
    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.
    date_rangeTime 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
    date_rangeTime Frame:
    From the last administration of Radium-223 till up to 6 months

Trial design

China Radium-223 safety and Effectiveness stuDy In real world mCRPC paTients
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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