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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2017 by Bayer
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT02398526
First received: March 20, 2015
Last updated: February 16, 2017
Last verified: February 2017
  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.

Condition Intervention
Castration-Resistant Prostatic Cancer
Drug: Radium-223 dichloride, (Xofigo, BAY88-8223)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: PARABO - Pain Evaluation in Radium-223 (Xofigo®) Treated mCRPC Patients With Bone Metastases - a Non-interventional Study in Nuclear Medicine Centers

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.

  • BSI as Imaging Biomarker in 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


Estimated Enrollment: 300
Study Start Date: March 2015
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Drug: Radium-223 dichloride, (Xofigo, BAY88-8223)
Dosage and treatment duration according to the decision of the treating physician

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02398526

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com

Locations
Germany
Recruiting
Many locations, Germany
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02398526     History of Changes
Other Study ID Numbers: 17550
XF1412DE ( Other Identifier: Company internal )
Study First Received: March 20, 2015
Last Updated: February 16, 2017

Keywords provided by Bayer:
Observational study
Bone metastases
Hormone Refractory Prostatic Cancer
Xofigo
Radium-223

Additional relevant MeSH terms:
Radium Ra 223 dichloride
Neoplasm Metastasis
Prostatic Neoplasms
Prostatic Neoplasms, Castration-Resistant
Neoplastic Processes
Neoplasms
Pathologic Processes
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Succinylcholine
Neuromuscular Depolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antineoplastic Agents

ClinicalTrials.gov processed this record on March 23, 2017