PARABO - Pain evaluation in Radium-223 (Xofigo®) treated mCRPC patients with bone metastases – a non-interventional study in nuclear medicine centers

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)
• Data collection methods:
  Combined primary and secondary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  100000157913

  radium (223Ra) dichloride
• Medical condition to be studied:
  Prostate cancer metastatic

Population studied

• Short description of the study population:
  Male patients with a diagnosis of CRPC with symptomatic bone metastases without known visceral metastases will be enrolled after the decision for treatment with Radium-223 has been made by the attending physician according to his/her medical practice.; ; Inclusion criterion/criteria;  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.;  Signed informed consent; ; Exclusion criterion/criteria;  Patients participating in an investigational program with interventions outside of routine clinical practice
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Prostate cancer patients
• Estimated number of subjects:
  350

Study design details

• Main study objective:
  The primary objective of this study is to evaluate pain response during Radium-223 treatment of mCRPC patients in a real life nuclear medicine practice setting.
• Outcomes:
  Pain response, Change of pain over time Change in bone pain related quality of life Pain control rate Pain progression rate Time to first pain progression Time to first opioid use Summary evaluation of covariates on pain response Relation between bone uptake in known lesions and pain palliation Dosage of Radium-223 Number of injections of Radium-223 Overall survival + 10 other secondary outcomes
• Data analysis plan:
  Statistical analyses will be primarily of explorative and descriptive nature. Patients receiving at least one dose of Radium-223 will be considered valid for safety analysis set. Analyses of pain or QoL will be performed for patients with evaluable patient questionnaires (BPI-SF, FACT-BP, respectively) at baseline and at least one post baseline visit. A clinically increase or decrease in opioid use will be taken into account. Further details will be defined in the SAP. Other analyses will be performed for the safety analysis set unless otherwise defined. Whenever reasonable, data will be stratified by subgroups (i.e. age, other baseline characteristics). All therapies documented will be coded using the World Health Organization – Drug Dictionary (WHO-DD). Medical history, any diseases and AEs will be coded using the latest MedicalDictionary for Regulatory Activities (MedDRA) version. It is planned to have one interim analysis at the time of 6 months after LPFV.

Documents

Study results

17750_EU PAS Abstract_2021-07-07

Study report

17550_Clinical Study Report_V1.0_20210601_redacted

17550_Clinical Study Report_V2.0_2021-06-28_redacted

Study, other information

17550_Clinical Study Report_V2.0_2021-06-28_redacted.pdf