Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
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 : December 24, 2020
Sponsor:
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date May 15, 2014
First Posted Date May 19, 2014
Last Update Posted Date December 24, 2020
Actual Study Start Date August 20, 2014
Estimated Primary Completion Date December 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 26, 2018)
  • Incidence of developing second primary malignancies [ Time Frame: From study start to 7 years post last dose of Radium-223 ]
  • Incidence of treatment-emergent SAEs [ Time Frame: From study start up to 30 days after the last administration of Radium-223 ]
  • Incidence of drug-related treatment-emergent adverse events [ Time Frame: From study start up to 30 days after the last administration of Radium-223 ]
  • Incidence of drug-related SAEs [ Time Frame: From study start to 7 years post last dose of Radium-223 ]
  • 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.
Original Primary Outcome Measures
 (submitted: May 15, 2014)
  • Incidence of developing second primary malignancies [ Time Frame: From study start to 7 years post last dose of Radium-223 ]
  • Incidence of treatment-emergent SAEs [ Time Frame: From study start up to 30 days after the last administration of Radium-223 ]
  • Incidence of drug-related treatment-emergent adverse events [ Time Frame: From study start up to 30 days after the last administration of Radium-223 ]
  • Incidence of drug-related SAEs [ Time Frame: From study start to 7 years post last dose of Radium-223 ]
  • Bone marrow suppression [ Time Frame: From study start to 7 years 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.
Change History
Current Secondary Outcome Measures
 (submitted: September 26, 2018)
  • Overall survival [ Time Frame: From study start to 7 years post last dose of Radium-223 ]
  • 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 ]
  • Incidence of bone fractures [ Time Frame: From study start to 7 years post last dose of Radium-223 ]
  • The number of bone associated events [ Time Frame: From study start to 7 years post last dose of Radium-223 ]
    e.g. osteoporosis
Original Secondary Outcome Measures
 (submitted: May 15, 2014)
  • Overall survival [ Time Frame: From study start to 7 years post last dose of Radium-223 ]
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Metastatic Castration-resistant Prostate Cancer
Intervention 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.
Study Groups/Cohorts Radium-223 dichloride (Xofigo, BAY88-8223)
Single-arm cohort observational study with CRPC patients with bone metastasis treated with Radium-223.
Intervention: Drug: Radium-223 dichloride (Xofigo, BAY88-8223)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: August 28, 2019)
1474
Original Estimated Enrollment
 (submitted: May 15, 2014)
1334
Estimated Study Completion Date February 28, 2025
Estimated Primary Completion Date December 31, 2024   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Argentina,   Austria,   Belgium,   Canada,   Colombia,   Czechia,   Denmark,   France,   Germany,   Greece,   Israel,   Italy,   Luxembourg,   Mexico,   Netherlands,   Portugal,   Spain,   Sweden,   United Kingdom,   United States
Removed Location Countries Brazil,   Czech Republic,   Norway,   Singapore,   Taiwan
 
Administrative Information
NCT Number NCT02141438
Other Study ID Numbers 16913
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Bayer
Study Sponsor Bayer
Collaborators Not Provided
Investigators
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date December 2020