We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Observational Study for the Evaluation of Long-term Safety of Radium-223 Used for the Treatment of Metastatic Castration Resistant Prostate Cancer (REASSURE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02141438
Recruitment Status : Active, not recruiting
First Posted : May 19, 2014
Last Update Posted : March 8, 2023
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
Observational study in the routine clinical practice setting to evaluate the short and long term safety profile of Radium-223 in metastatic castration resistant prostate cancer patients and to evaluate the risk of developing second primary cancers.

Condition or disease Intervention/treatment
Metastatic Castration-resistant Prostate Cancer Drug: Radium-223 dichloride (Xofigo, BAY88-8223)

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 1474 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Radium-223 Alpha Emitter Agent in Non-intervention Safety Study in mCRPC popUlation for Long-teRm Evaluation
Actual Study Start Date : August 20, 2014
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : February 28, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Radium-223 dichloride (Xofigo, BAY88-8223)
Single-arm cohort observational study with CRPC patients with bone metastasis treated with Radium-223.
 Drug: Radium-223 dichloride (Xofigo, BAY88-8223)
This is a non-interventional study, the drug is used in its authorized indication from commercial supply. The decision to treat with Radium-223 will be agreed upon between the physician and the patient independently and prior to providing the patient study information. Treatment with Radium-223 should follow the approved local product information.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Incidence of developing second primary malignancies [ Time Frame: From study start to 7 years post last dose of Radium-223 ]
  2. Incidence of treatment-emergent SAEs [ Time Frame: From study start up to 30 days after the last administration of Radium-223 ]
  3. Incidence of drug-related treatment-emergent adverse events [ Time Frame: From study start up to 30 days after the last administration of Radium-223 ]
  4. Incidence of drug-related SAEs [ Time Frame: From study start to 7 years post last dose of Radium-223 ]
  5. Bone marrow suppression [ Time Frame: From study start to 6 months post last dose of Radium-223 ]
    Therapeutic/prevention measures/treatment modalities, Gr. 3/4 hematological toxicities (up to 6 months after last administration), platelet or WBC < lower limit of normal during treatment +30 days will be followed to resolution (up to 6 months after last administration), and febrile neutropenia and hemorrhage for patients who start subsequent chemotherapy will be assessed.


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: From study start to 7 years post last dose of Radium-223 ]
  2. The worst pain score and pain interference score over time as determined by patient responses on the "Brief pain inventory short form" (BPI-SF) questionnaire [ Time Frame: From study start to 6 months post last dose of Radium-223 ]
  3. Incidence of bone fractures [ Time Frame: From study start to 7 years post last dose of Radium-223 ]
  4. The number of bone associated events [ Time Frame: From study start to 7 years post last dose of Radium-223 ]
    e.g. osteoporosis


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with histologically or cytologically confirmed castration resistant adenocarcinoma of the prostate with bone metastases for whom the treatment decision to Radium-223 has been made independent from and before patient enrolment in the study.
Criteria

Inclusion Criteria:

  • Treatment decision to Radium-223 needs to be made independent from and before patient enrollment in the study
  • Histologically or cytologically confirmed castration resistant adenocarcinoma of the prostate with bone metastases
  • Signed informed consent

Exclusion Criteria:

  • Previously treated with Radium-223 for any reason
  • Currently treated in clinical trials including other Radium-223 studies
  • Planned for the systemic concomitant use of other radiopharmaceuticals for treatment of prostate cancer or for other use
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02141438


Locations
Show Show 72 study locations
Sponsors and Collaborators
Bayer
Investigators
Layout table for investigator information
Study Director: Bayer Study Director Bayer
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02141438    
Other Study ID Numbers: 16913
First Posted: May 19, 2014    Key Record Dates
Last Update Posted: March 8, 2023
Last Verified: March 2023
Keywords provided by Bayer:
Radium-223
CRPC
Phase IV
Safety study
Additional relevant MeSH terms:
Layout table for MeSH terms
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Prostatic Diseases
Radium Ra 223 dichloride
Antineoplastic Agents