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

Castration-Resistant Prostatic Cancer Clinical Trial

— PARABO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02398526
• Other study ID #: 17550
• Secondary ID: XF1412DE
• Status: Completed
• Start date: March 19, 2015
• Est. completion date: July 15, 2020

Study information

• Verified date: October 2021
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 363
• Est. completion date: July 15, 2020
• Est. primary completion date: May 20, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Castration-Resistant Prostatic Cancer
• Neoplasm Metastasis
• Prostatic Neoplasms
• Prostatic Neoplasms, Castration-Resistant

Intervention

Drug:
• Radium-223 dichloride, (Xofigo, BAY88-8223)
Dosage and treatment duration according to the decision of the treating physician

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to 6 months
Secondary	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.	Up to 6 months from baseline
Secondary	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	Up to 6 months from baseline
Secondary	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.	Up to 6 months
Secondary	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.	Up to 6 months
Secondary	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	Up to 6 months
Secondary	Time to first opioid use		Up to 5.5 years
Secondary	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	Up to 6 months
Secondary	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	Up to 6 months
Secondary	Dosage of Radium-223		Up to 5 months
Secondary	Number of injections of Radium-223		Up to 5 months
Secondary	Course of blood count presented as percentage of patients below limit for further injections according to the local product information		Up to 5 months
Secondary	Number of participants with Treatment-emergent Adverse Events (TEAE)		Up to 6 months
Secondary	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	Up to 5.5 years
Secondary	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	Up to 5.5 years
Secondary	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.	Up to 5.5 years
Secondary	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	Up to 6 months
Secondary	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)	Up to 5.5 years
Secondary	Time from castration resistance to treatment with Radium-223	Time from verified castration resistance to first injection of Radium-223	First treatment
Secondary	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.	Up to 6 months
Secondary	Factors positively influencing mCRPC patients to get = 5 injections versus = 4 injections	(e.g. concomitant use of antihormonal therapy, no pre-treatment of chemotherapy)	Up to 6 months
Secondary	Incidence of pathological fractures, non-pathological fractures and bone associated events during treatment and follow up		Up to 5.5 years

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