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.
Study Type
OBSERVATIONAL
Enrollment
363
Dosage and treatment duration according to the decision of the treating physician
Unnamed facility
Multiple Locations, Germany
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.
Time frame: Up to 6 months
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.
Time frame: Up to 6 months from baseline
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
Time frame: Up to 6 months from baseline
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.
Time frame: Up to 6 months
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.
Time frame: Up to 6 months
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
Time frame: Up to 6 months
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Time to first opioid use
Time frame: Up to 5.5 years
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
Time frame: Up to 6 months
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
Time frame: Up to 6 months
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)
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 frame: Up to 5.5 years
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
Time frame: Up to 5.5 years
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.
Time frame: Up to 5.5 years
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
Time frame: Up to 6 months
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)
Time 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
Time 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.
Time 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)
Time frame: Up to 6 months
Incidence of pathological fractures, non-pathological fractures and bone associated events during treatment and follow up
Time frame: Up to 5.5 years