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Trial record 1 of 1 for:    reassure radium 223 alpha emitter agent in safety study in mCRPC
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Observational Study for the Evaluation of Long-term Safety of Radium-223 Used for the Treatment of Metastatic Castration Resistant Prostate Cancer (REASSURE)

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ClinicalTrials.gov Identifier: NCT02141438
Recruitment Status : Active, not recruiting
First Posted : May 19, 2014
Last Update Posted : June 15, 2018
Sponsor:
Information provided by (Responsible Party):
Bayer

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
Prostatic Neoplasms Drug: Radium-223 dichloride (Xofigo, BAY88-8223)

Study Type : Observational
Actual Enrollment : 1482 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 : September 30, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Group/Cohort Intervention/treatment
Cohort 1
Single-arm cohort study
Drug: Radium-223 dichloride (Xofigo, BAY88-8223)
An alpha particle-emitting radioactive therapeutic agent indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease




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 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.


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 ]


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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

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


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Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02141438     History of Changes
Other Study ID Numbers: 16913
First Posted: May 19, 2014    Key Record Dates
Last Update Posted: June 15, 2018
Last Verified: June 2018

Keywords provided by Bayer:
Radium-223
Metastatic castration-resistant prostate cancer
CRPC
Phase IV
Safety study

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Radium Ra 223 dichloride
Antineoplastic Agents