Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    xofigo parabo
Previous Study | Return to List | Next Study

Pain Evaluation in Radium-223 Treated Castration Resistant Prostate Cancer Patients With Bone Metastases (PARABO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02398526
Recruitment Status : Completed
First Posted : March 25, 2015
Last Update Posted : November 2, 2021
Sponsor:
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date March 20, 2015
First Posted Date March 25, 2015
Last Update Posted Date November 2, 2021
Actual Study Start Date March 19, 2015
Actual Primary Completion Date May 20, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 20, 2015)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: October 22, 2018)
  • 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 5.5 years ]
  • Summary description 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, BSI
  • 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 5.5 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 5.5 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 5.5 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.
  • Bone Scan Index (BSI) as Imaging Biomarker in metastatic castration-resistant prostate cancer (mCRPC) [ Time Frame: Up to 6 months ]
    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
  • Effect of concomitant drug treatment on pain, quality of life, and overall survival [ Time Frame: Up to 5.5 years ]
    Exploration of the influence of abiraterone, enzalutamide, opioids and denosumab on OS by number of injections (5-6 vs. 1-4)
  • Time from castration resistance to treatment with Radium-223 [ Time Frame: First treatment ]
    Time from verified castration resistance to first injection of Radium-223
  • Description of covariates on duration of therapy [ Time Frame: Up to 6 months ]
    Description of covariates on duration of therapy (to get ≥ 5 injections versus ≤ 4 injections) of mCRPC patients during treatment with Radium-223.
  • Factors positively influencing mCRPC patients to get ≥ 5 injections versus ≤ 4 injections [ Time Frame: Up to 6 months ]
    (e.g. concomitant use of antihormonal therapy, no pre-treatment of chemotherapy)
  • Incidence of pathological fractures, non-pathological fractures and bone associated events during treatment and follow up [ Time Frame: Up to 5.5 years ]
Original Secondary Outcome Measures
 (submitted: March 20, 2015)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Pain Evaluation in Radium-223 Treated Castration Resistant Prostate Cancer Patients With Bone Metastases
Official Title PARABO - Pain Evaluation in Radium-223 (Xofigo®) Treated mCRPC Patients With Bone Metastases - a Non-interventional Study in Nuclear Medicine Centers
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The study population will consist of castration resistant prostate cancer patients with bone metastases treated with Radium-223.
Condition Castration-Resistant Prostatic Cancer
Intervention Drug: Radium-223 dichloride, (Xofigo, BAY88-8223)
Dosage and treatment duration according to the decision of the treating physician
Study Groups/Cohorts Radium-223 dichloride
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.
Intervention: Drug: Radium-223 dichloride, (Xofigo, BAY88-8223)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 29, 2020)
363
Original Estimated Enrollment
 (submitted: March 20, 2015)
300
Actual Study Completion Date July 15, 2020
Actual Primary Completion Date May 20, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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

Exclusion Criteria:

  • Patients participating in an investigational program with interventions outside of routine clinical practice or participating in another observational study with Xofigo
Sex/Gender
Sexes Eligible for Study: Male
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT02398526
Other Study ID Numbers 17550
XF1412DE ( Other Identifier: Company internal )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Bayer
Study Sponsor Bayer
Collaborators Not Provided
Investigators
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date October 2021