Trial Condition(s):

Metastatic castration-resistant prostate cancer

Observational study for the evaluation of long-term safety of Radium-223 used for the treatment of metastatic castration resistant prostate cancer (REASSURE)

Bayer Identifier:

16913

ClinicalTrials.gov Identifier:

NCT02141438

EudraCT Number:

Not Available

EU CT Number:

Not Available

Recruitment Complete

Trial Purpose

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.

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

Trial Summary

Enrollment Goal
1474
Trial Dates
black-arrow
Phase
4
Could I receive a placebo?
No
Products
Xofigo (Radium-223 dichloride, BAY88-8223)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Omaha, United States

Status
Active, not recruiting
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Investigative Site

Many Locations, Germany

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Active, not recruiting
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Many Locations, United Kingdom

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Active, not recruiting
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Investigative Site

Many Locations, France

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Active, not recruiting
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Investigative Site

Many Locations, Italy

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Active, not recruiting
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Many Locations, Spain

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Active, not recruiting
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Investigative Site

Many Locations, Belgium

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Active, not recruiting
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Many Locations, Netherlands

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Active, not recruiting
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Many Locations, Sweden

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Active, not recruiting
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Many Locations, Denmark

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Active, not recruiting
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Many Locations, Czech Republic

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Active, not recruiting
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Many Locations, Israel

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Active, not recruiting
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Many Locations, Austria

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Active, not recruiting
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Many Locations, Luxembourg

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Active, not recruiting
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Many Locations, Greece

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Active, not recruiting
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Investigative Site

Many locations, Mexico

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Active, not recruiting
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Many Locations, Portugal

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Active, not recruiting
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Many Locations, Argentina

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Active, not recruiting
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Investigative Site

Lake Success, United States

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Active, not recruiting
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Anchorage, United States

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Active, not recruiting
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Homewood, United States

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Active, not recruiting
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Springfield, United States

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Active, not recruiting
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Plantation, United States

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Active, not recruiting
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Fort Myers, United States

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Active, not recruiting
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Scottsdale, United States

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Active, not recruiting
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Lakewood Ranch, United States

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Active, not recruiting
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Syracuse, United States

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Active, not recruiting
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Myrtle Beach, United States

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Active, not recruiting
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Troy, United States

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Active, not recruiting
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Nashville, United States

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Active, not recruiting
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Middleburg Heights, United States

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Active, not recruiting
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San Diego, United States

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Active, not recruiting
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New Orleans, United States

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Active, not recruiting
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Virginia Beach, United States

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Active, not recruiting
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Long Beach, United States

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Active, not recruiting
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Colorado Springs, United States

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Active, not recruiting
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Boston, United States

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Active, not recruiting
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Daly City, United States

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Active, not recruiting
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Billings, United States

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Active, not recruiting
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Warrenville, United States

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Active, not recruiting
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Boca Raton, United States

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Active, not recruiting
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Lubbock, United States

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Active, not recruiting
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Wichita, United States

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Active, not recruiting
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Temple, United States

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Active, not recruiting
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Oklahoma City, United States

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Active, not recruiting
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Baltimore, United States

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Active, not recruiting
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East Setauket, United States

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Active, not recruiting
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Houston, United States

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Active, not recruiting
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Seattle, United States

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Active, not recruiting
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Sacramento, United States

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Active, not recruiting
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Saint Louis, United States

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Active, not recruiting
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Urbana, United States

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Active, not recruiting
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San Antonio, United States

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Active, not recruiting
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Abington, United States

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Active, not recruiting
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Investigative Site

Many Locations, Canada

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Active, not recruiting
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Buffalo, United States

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Active, not recruiting
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Winston-Salem, United States

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Active, not recruiting
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Atlanta, United States

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Active, not recruiting
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Township, United States

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Active, not recruiting
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Charleston, United States

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Active, not recruiting
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Evanston, United States

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Active, not recruiting
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Honolulu, United States

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Active, not recruiting
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Charlottesville, United States

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Active, not recruiting
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St. Louis, United States

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Active, not recruiting
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Many Locations, Colombia

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Active, not recruiting
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Rockville, United States

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Active, not recruiting
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Neptune, United States

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Active, not recruiting
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Maywood, United States

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Active, not recruiting
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Decatur, United States

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Active, not recruiting
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Jacksonville, United States

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Active, not recruiting
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Towson, United States

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Active, not recruiting
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Investigative Site

Lebanon, United States

Status
Active, not recruiting
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Investigative Site

Ashland, United States

Status
Active, not recruiting

Trial Design