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Drug Use Investigation of Xofigo, Castration Resistant Prostate Cancer With Bone Metastases

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by Bayer
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT02803437
First received: June 14, 2016
Last updated: September 1, 2016
Last verified: September 2016
  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.

Condition Intervention
Prostatic Neoplasms, Castration-Resistant
Drug: Radium-223 dichloride (Xofigo, BAY 88-8223)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Drug Use Investigation of Xofigo, Castration Resistant Prostate Cancer With Bone Metastases

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Number of adverse events as a measure of safety [ Time Frame: Up to 6 months ] [ Designated as safety issue: Yes ]
    Events will be summarized by frequency tables (e.g. absolute and relative frequencies) using the MedDRA coding system

  • Number of Adverse drug reactions as a measure of safety [ Time Frame: Up to 6 months ] [ Designated as safety issue: Yes ]
    Events will be summarized by frequency tables (e.g. absolute and relative frequencies) using the MedDRA coding system


Secondary Outcome Measures:
  • Change in laboratory findings (e.g. ALP, bone markers) [ Time Frame: From Baseline up to 6 month ] [ Designated as safety issue: No ]
  • Change in Analgesic use as a surrogate of pain status [ Time Frame: From Baseline up to 6 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: July 2016
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Xofigo / Cohort 1
Patients suffered from CRPC with bone metastases are enrolled after the physician's decision of Xofigo treatment under the routine clinical practice.
Drug: Radium-223 dichloride (Xofigo, BAY 88-8223)
Xofigo treatment will be performed according to the product label in Japan under the routine clinical practice.

Detailed Description:

This is a local, non-interventional, multi-center, single-cohort study using primary data of patients treated with Xofigo for the indication of castration resistant prostate cancer (CRPC) with bone metastases. A total of 300 patients (valid for safety analysis) are enrolled within 18 months.

During the observation period, safety and effectiveness information is collected. Since patient's visit occurs under the routine clinical practice, the study protocol does not define exact referral dates for those visits. The physician records patient data as defined in the protocol.

The outcome variables for the primary objective are Treatment Emergent Adverse Event (TEAEs) and Adverse Drug Reaction (ADRs). The outcome variables for secondary objectives include laboratory findings (e.g. Alkaline Phosphatase [ALP], bone markers if measured) and pain status (analgesic utility).

The results of this study have to be submitted to the Japanese regulatory authorities as a part of the re-examination package after the completion of the re-examination period (8 years). This study is conducted in accordance with Article 14-4 (re-examination) of the Pharmaceutical Affairs Law, and Good Post-marketing Surveillance Practice from a ministerial ordinance of Ministry of Health, Labor and Welfare in Japan.

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients suffered from castration resistant prostate cancer with bone metastases
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patients treated Xofigo previously
  • Patients participating in an investigational program with interventions outside of routine clinical practice
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02803437

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayer.com

Locations
Japan
Recruiting
Many locations, Japan
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02803437     History of Changes
Other Study ID Numbers: 18212 
Study First Received: June 14, 2016
Last Updated: September 1, 2016
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Bayer:
Castration-resistant prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Prostatic Neoplasms, Castration-Resistant
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Succinylcholine
Radium Ra 223 dichloride
Neuromuscular Depolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 28, 2016