last updated at 22.08.2019

REASSURE

Radium-223 Alpha Emitter Agent in Non-intervention Safety Study in mCRPC popUlation for Long-teRm Evaluation

Status: Aktiv (Rekrutierung geschlossen)

ISRCTN EudraCT Clinicaltrials.gov DRKS
NCT02141438

Diagnose

  • Prostatakarzinom

Studienziel / Fragestellung

Primäres Prüfziel
    • 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.
Sekundäre Prüfziele
    • 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 ]

Patientenmerkmale

Alter

18-99

Ausschlusskriterien

     

  • 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
  •  

Einschlusskriterien

     

  • 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
  •  

Studiendesign

  • Einarmig
  • Multizentrisch
  • Open Label
  • Phase IV
  • Prospektiv

Intervention


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

Dokumente (passwortgeschützt)

Zuständigkeiten Gesamtstudie

Sponsor

  • Bayer HealthCare AG

Prüfzentrum 1

 

  • Klinik für Urologie

Studienbüro

  • Klinik für Urologie

Prüfer (Hauptprüfer im Zentrum)

Prof.Dr.med Anja Lorch

Studienkontakt im Prüfzentrum

  • Prof.Dr.med Anja Lorch

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