Clinical trial NCT02141438: Observational Study for the Evaluation of Long-term Safety of Radium-223 Used for the Treatment of Metastatic Castration Resistant Prostate Cancer
Official title: Radium-223 Alpha Emitter Agent in Non-intervention Safety Study in mCRPC popUlation for Long-teRm Evaluation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Castration-resistant Prostate Cancer
Keywords: Radium-223
CRPC
Phase IV
Safety study
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2014-05-19
Enrollment: 1474
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: Incidence of developing second primary malignancies
timeFrame: From study start to 7 years post last dose of Radium-223
measure: Incidence of treatment-emergent SAEs
timeFrame: From study start up to 30 days after the last administration of Radium-223
measure: Incidence of drug-related treatment-emergent adverse events
timeFrame: From study start up to 30 days after the last administration of Radium-223
measure: Incidence of drug-related SAEs
timeFrame: From study start to 7 years post last dose of Radium-223
measure: Bone marrow suppression
timeFrame: From study start to 6 months post last dose of Radium-223
Secondary outcomes:
measure: Overall survival
timeFrame: From study start to 7 years post last dose of Radium-223
measure: 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
timeFrame: From study start to 6 months post last dose of Radium-223
measure: Incidence of bone fractures
timeFrame: From study start to 7 years post last dose of Radium-223
measure: The number of bone associated events
timeFrame: From study start to 7 years post last dose of Radium-223
Other outcomes:
Locations:
city: Anchorage
country: United States
state: Alaska
city: Scottsdale
country: United States
state: Arizona
city: Daly City
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Diego
country: United States
state: California
city: Colorado Springs
country: United States
state: Colorado
city: Boca Raton
country: United States
state: Florida
city: Fort Myers
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Lakewood Ranch
country: United States
state: Florida
city: Plantation
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Decatur
country: United States
state: Georgia
city: Honolulu
country: United States
state: Hawaii
city: Evanston
country: United States
state: Illinois
city: Warrenville
country: United States
state: Illinois
city: Wichita
country: United States
state: Kansas
city: Ashland
country: United States
state: Kentucky
city: New Orleans
country: United States
state: Louisiana
city: Baltimore
country: United States
state: Maryland
city: Rockville
country: United States
state: Maryland
city: Towson
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Troy
country: United States
state: Michigan
city: Saint Louis
country: United States
state: Missouri
city: Billings
country: United States
state: Montana
city: Omaha
country: United States
state: Nebraska
city: Lebanon
country: United States
state: New Hampshire
city: Neptune
country: United States
state: New Jersey
city: Township
country: United States
state: New Jersey
city: Buffalo
country: United States
state: New York
city: East Setauket
country: United States
state: New York
city: Lake Success
country: United States
state: New York
city: Winston-Salem
country: United States
state: North Carolina
city: Middleburg Heights
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Springfield
country: United States
state: Oregon
city: Abington
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Myrtle Beach
country: United States
state: South Carolina
city: Nashville
country: United States
state: Tennessee
city: Houston
country: United States
state: Texas
city: Lubbock
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Temple
country: United States
state: Texas
city: Charlottesville
country: United States
state: Virginia
city: Virginia Beach
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Multiple Locations
country: Argentina
city: Multiple Locations
country: Austria
city: Multiple Locations
country: Belgium
city: Multiple Locations
country: Canada
city: Multiple Locations
country: Colombia
city: Multiple Locations
country: Czechia
city: Multiple Locations
country: Denmark
city: Multiple Locations
country: France
city: Multiple Locations
country: Germany
city: Multiple Locations
country: Greece
city: Multiple Locations
country: Israel
city: Multiple Locations
country: Italy
city: Multiple Locations
country: Luxembourg
city: Multiple Locations
country: Mexico
city: Multiple Locations
country: Netherlands
city: Multiple Locations
country: Portugal
city: Multiple Locations
country: Spain
city: Multiple Locations
country: Sweden
city: Multiple Locations
country: United Kingdom
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Sartor O, Fougere C, Essler M, Ezziddin S, Kramer G, Ellinger J, Nordquist L, Sylvester J, Paganelli G, Peer A, Bogemann M, Meltzer J, Sandstrom P, Verholen F, Song DY. 177Lu-Prostate-Specific Membrane Antigen Ligand After 223Ra Treatment in Men with Bone-Metastatic Castration-Resistant Prostate Cancer: Real-World Clinical Experience. J Nucl Med. 2022 Mar;63(3):410-414. doi: 10.2967/jnumed.121.262240. Epub 2021 Jun 24.