check_circleStudy Completed

Castration-Resistant Prostatic Cancer

Bayer Identifier:

17550

ClinicalTrials.gov Identifier:

NCT02398526

EudraCT Number:

Not Available

EU CT Number:

Not Available
Pain evaluation in Radium-223 treated castration resistant prostate cancer patients with bone metastases

Trial purpose

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.

Key Participants Requirements

Sex

Male

Age

18 - N/A
  • - 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
  • - Patients participating in an investigational program with interventions outside of routine clinical practice or participating in another observational study with Xofigo

Trial summary

Enrollment Goal
363
Trial Dates
March 2015 - July 2020
Phase
N/A
Could I Receive a placebo
No
Products
Xofigo (Radium-223 dichloride, BAY88-8223)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many locations, Germany

Primary Outcome

  • Pain response
    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.
    date_rangeTime Frame:
    Up to 6 months
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Change of pain over time
    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.
    date_rangeTime Frame:
    Up to 6 months from baseline
    enhanced_encryption
    Safety Issue:
    No
  • Change in bone pain related quality of life
    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
    date_rangeTime Frame:
    Up to 6 months from baseline
    enhanced_encryption
    Safety Issue:
    No
  • Pain control rate
    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.
    date_rangeTime Frame:
    Up to 6 months
    enhanced_encryption
    Safety Issue:
    No
  • Pain progression rate
    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.
    date_rangeTime Frame:
    Up to 6 months
    enhanced_encryption
    Safety Issue:
    No
  • Time to first pain progression
    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
    date_rangeTime Frame:
    Up to 6 months
    enhanced_encryption
    Safety Issue:
    No
  • Time to first opioid use
    date_rangeTime Frame:
    Up to 5.5 years
    enhanced_encryption
    Safety Issue:
    No
  • Summary description of covariates on pain response
    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, BSI
    date_rangeTime Frame:
    Up to 6 months
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    Safety Issue:
    No
  • Relation between bone uptake in known lesions and pain palliation
    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
    date_rangeTime Frame:
    Up to 6 months
    enhanced_encryption
    Safety Issue:
    No
  • Dosage of Radium-223
    date_rangeTime Frame:
    Up to 5 months
    enhanced_encryption
    Safety Issue:
    No
  • Number of injections of Radium-223
    date_rangeTime Frame:
    Up to 5 months
    enhanced_encryption
    Safety Issue:
    No
  • Course of blood count presented as percentage of patients below limit for further injections according to the local product information
    date_rangeTime Frame:
    Up to 5 months
    enhanced_encryption
    Safety Issue:
    No
  • Number of participants with Treatment-emergent Adverse Events (TEAE)
    date_rangeTime Frame:
    Up to 6 months
    enhanced_encryption
    Safety Issue:
    Yes
  • Time to next tumor treatment(s) (TTNT)
    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
    date_rangeTime Frame:
    Up to 5.5 years
    enhanced_encryption
    Safety Issue:
    No
  • Time to first symptomatic skeletal event (SSE)
    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
    date_rangeTime Frame:
    Up to 5.5 years
    enhanced_encryption
    Safety Issue:
    No
  • Overall survival
    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.
    date_rangeTime Frame:
    Up to 5.5 years
    enhanced_encryption
    Safety Issue:
    No
  • Bone Scan Index (BSI) as Imaging Biomarker in metastatic castration-resistant prostate cancer (mCRPC)
    Evaluated by comparing BSI values before and after Radium-223 treatment as well as by investigating the association of BSI with other outcome parameters like OS
    date_rangeTime Frame:
    Up to 6 months
    enhanced_encryption
    Safety Issue:
    No
  • Effect of concomitant drug treatment on pain, quality of life, and overall survival
    Exploration of the influence of abiraterone, enzalutamide, opioids and denosumab on OS by number of injections (5-6 vs. 1-4)
    date_rangeTime Frame:
    Up to 5.5 years
  • Time from castration resistance to treatment with Radium-223
    Time from verified castration resistance to first injection of Radium-223
    date_rangeTime Frame:
    First treatment
  • Description of covariates on duration of therapy
    Description of covariates on duration of therapy (to get ≥ 5 injections versus ≤ 4 injections) of mCRPC patients during treatment with Radium-223.
    date_rangeTime Frame:
    Up to 6 months
  • Factors positively influencing mCRPC patients to get ≥ 5 injections versus ≤ 4 injections
    (e.g. concomitant use of antihormonal therapy, no pre-treatment of chemotherapy)
    date_rangeTime Frame:
    Up to 6 months
  • Incidence of pathological fractures, non-pathological fractures and bone associated events during treatment and follow up
    date_rangeTime Frame:
    Up to 5.5 years

Trial design

PARABO - Pain evaluation in Radium-223 (Xofigo®) treated mCRPC patients with bone metastases – a non-interventional study in nuclear medicine centers
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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