Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00008811

Trial Description

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Title

PARABO - Pain Evaluation in Radium-223 (Xofigo®) Treated mCRPC Patients With Bone Metastases - a Non-interventional Study in Nuclear Medicine Centers

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Trial Acronym

PARABO

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URL of the Trial

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Brief Summary in Lay Language

This observational prospective single arm cohort study is designed to assess pain and bone
pain related quality of life of metastatic Castration Resistant Prostate Cancer (mCRPC)
patients receiving Radium-223 in a real life nuclear medicine practice setting. In addition,
overall survival, time to next tumor treatment (TTNT), time to first symptomatic skeletal
event (SSE), course of blood counts, and safety will be assessed.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00008811
  •   2015/06/25
  •   2015/03/20
  •   no
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Secondary IDs

  •   NCT02398526  (ClinicalTrials.gov)
  •   17550  (Bayer)
  •   XF1412DE 
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Health Condition or Problem studied

  •   Castration-Resistant Prostatic Cancer
  •   C61 -  Malignant neoplasm of prostate
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Interventions/Observational Groups

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

  •   Non-interventional
  •   Observational study
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  •   N/A
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Primary Outcome

- Pain response; time frame: Up to 6 months; Determined by the worst pain item on the Brief Pain Inventory - Short Form (BPI-SF) patient questionnaire. A clinically meaningful pain response is defined as an improvement of two points from the baseline BPI-SF worst pain score at any post-baseline assessment.

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Secondary Outcome

- Change of pain over time; time frame: Up to 6 months from baseline; Determined by evaluating the worst pain item as well as the subscale scores for pain severity and pain interference as determined by patient responses on the BPI-SF questionnaire.
- Change in bone pain related quality of life; time frame: Up to 6 months from baseline; As determined by patient responses on the bone pain specific Functional Assessment of Cancer Therapy Quality of Life Measurement in patients with bone pain (FACT-BP) questionnaire
- Pain control rate; time frame: Up to 6 months; As determined by the worst pain item on the BPI-SF patient questionnaire. Pain control is defined as no increase by two points from the baseline BPI-SF worst pain score.
- Pain progression rate; time frame: Up to 6 months; As determined by the worst pain item on the BPI-SF patient questionnaire. Pain progression is defined as an increase by two points from the baseline BPI-SF worst pain score at any post baseline assessment.
- Time to first pain progression; time frame: Up to 6 months; Defined as the time between the first injection of Radium-223 until an increase in the BPI-SF worst pain item by at least two points
- Time to first opioid use; time frame: Up to 2.5 years
- Summary evaluation of covariates on pain response; time frame: Up to 6 months; The following covariates will be analyzed: opioid use, assessment of extent of bone metastases, location of bone metastases,level of alkaline phosphatase at baseline, PSA (Prostate Specific Antigen) level at baseline, WHO pain score at baseline, pretreatment with chemotherapy (yes/no), pretreatment with deep androgen ablation by treatment with abiraterone or enzalutamide (yes/no), extent of bone uptake in known lesions
- Relation between bone uptake in known lesions and pain palliation; time frame: Up to 6 months; Only in patients with bone scan prior to start of treatment and a second scan during or within 6 weeks after end of Radium-223 treatment
- Dosage of Radium-223; time frame: Up to 5 months
- Number of injections of Radium-223; time frame: Up to 5 months
- Course of blood count presented as percentage of patients below limit for further injections according to the local product information; time frame: Up to 5 months
- Number of participants with Treatment-emergent Adverse Events (TEAE); time frame: Up to 6 months
- Time to next tumor treatment(s) (TTNT); time frame: Up to 2.5 years; Defined as the time from the first application of Radium-223 until start of next mCRPC treatment including e.g. chemotherapy and/or hormonal treatment
- Time to first symptomatic skeletal event (SSE); time frame: Up to 2.5 years; Defined as the time between the first injection of Radium-223 until the occurrence of first SSE defined as the first use of external beam radiation therapy to relieve skeletal symptoms, new symptomatic pathological vertebral or non-vertebral bone fractures, spinal cord compression, or tumor-related orthopedic surgical intervention
- Overall survival; time frame: Up to 2.5 years; Defined as the time interval from the start of Radium-223 therapy to death, due to any cause. Patients alive at the end of the study will be censored at the last date known to be alive.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

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  •   2015/03/31
  •   300
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- Adult male patients diagnosed with CRPC with symptomatic bone metastases without
known visceral metastases

- Decision to initiate treatment with Radium-223 was made as per investigator's routine
treatment practice

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Exclusion Criteria

- Patients participating in an investigational program with interventions outside of
routine clinical practice or participating in another observational study with Xofigo

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Addresses

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    • Bayer
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    • Bayer
    • Bayer Study Director 
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    • Bayer Clinical Trials Contact 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   3
  •   2016/01/14


* This entry means the parameter is not applicable or has not been set.