Pain Evaluation in Radium-223 Treated Castration Resistant Prostate Cancer Patients With Bone Metastases
- Conditions
- Castration-Resistant Prostatic Cancer
- Interventions
- Registration Number
- NCT02398526
- Lead Sponsor
- Bayer
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 363
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Radium-223 dichloride Radium-223 dichloride, (Xofigo, BAY88-8223) 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.
- Primary Outcome Measures
Name Time Method Pain response 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
Name Time Method Time to first pain progression 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
Summary description of covariates on pain response 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
Number of participants with Treatment-emergent Adverse Events (TEAE) Up to 6 months Overall survival 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) 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
Change in bone pain related quality of life 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 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 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.
Incidence of pathological fractures, non-pathological fractures and bone associated events during treatment and follow up Up to 5.5 years Time to first opioid use Up to 5.5 years Relation between bone uptake in known lesions and pain palliation 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
Course of blood count presented as percentage of patients below limit for further injections according to the local product information Up to 5 months Change of pain over time 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.
Dosage of Radium-223 Up to 5 months Number of injections of Radium-223 Up to 5 months Time to next tumor treatment(s) (TTNT) 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) 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
Time from castration resistance to treatment with Radium-223 First treatment Time from verified castration resistance to first injection of Radium-223
Effect of concomitant drug treatment on pain, quality of life, and overall survival 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)
Description of covariates on duration of therapy 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 Up to 6 months (e.g. concomitant use of antihormonal therapy, no pre-treatment of chemotherapy)