check_circleStudy Completed

Prostatic Neoplasms, Castration-Resistant

Bayer Identifier:

18212

ClinicalTrials.gov Identifier:

NCT02803437

EudraCT Number:

Not Available

EU CT Number:

Not Available
Drug use investigation of Xofigo, castration resistant prostate cancer with bone metastases

Trial purpose

This study is a Japanese post-marketing surveillance (PMS) which is required by the regulatory authorities. General objective of PMS is to confirm the clinical usefulness, especially the safety profile of a drug under the routine clinical practice.

Key Participants Requirements

Sex

Male

Age

NaN - N/A
  • - Patients suffered from CRPC with bone metastases
    - Patients for whom the decision to initiate treatment with Xofigo is made as per physician’s routine clinical practice.
    - Xofigo treatment naïve


  • - Patients treated Xofigo previously
    - Patients participating in an investigational program with interventions outside of routine clinical practice

Trial summary

Enrollment Goal
334
Trial Dates
July 2016 - December 2024
Phase
Phase 4
Could I Receive a placebo
No
Products
Xofigo (Radium-223 dichloride, BAY88-8223)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many locations, Japan

Primary Outcome

  • Number of adverse events as a measure of safety
    Events will be summarized by frequency tables (e.g. absolute and relative frequencies) using the MedDRA coding system
    date_rangeTime Frame:
    Up to 6 months
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of adverse drug reactions as a measure of safety
    Events will be summarized by frequency tables (e.g. absolute and relative frequencies) using the MedDRA coding system
    date_rangeTime Frame:
    Up to 6 months
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Change in laboratory findings (e.g. ALP, bone markers)
    date_rangeTime Frame:
    From Baseline up to 6 month
    enhanced_encryption
    Safety Issue:
    No
  • Change in analgesic use as a surrogate of pain status
    date_rangeTime Frame:
    From Baseline up to 6 month
    enhanced_encryption
    Safety Issue:
    No
  • Number of patients with bone fractures
    date_rangeTime Frame:
    Up to 3 years
  • Survival rate
    date_rangeTime Frame:
    Up to 3 years
  • Post-treatment information
    Comprises information of post-treatment medication/ therapy for prostate cancer
    date_rangeTime Frame:
    Up to 3 years

Trial design

Drug use investigation of Xofigo, castration resistant prostate cancer with bone metastases
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

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.