Trial Condition(s):
Castration-Resistant Prostatic Cancer
Pain evaluation in Radium-223 treated castration resistant prostate cancer patients with bone metastases (PARABO)
Bayer Identifier:
17550
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study Completed
Trial 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.
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
Trial Summary
Enrollment Goal
363
Trial Dates
Phase
N/A
Could I receive a placebo?
No
Products
Xofigo (Radium-223 dichloride, BAY88-8223)
Accepts Healthy Volunteers
No
Where to Participate
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Locations
| Locations | |
|---|---|
Locations Investigative Site Many locations, Germany | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Trial Design
PARABO - Pain evaluation in Radium-223 (Xofigo®) treated mCRPC patients with bone metastases – a non-interventional study in nuclear medicine centers
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Pain responseDetermined 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.Timeframe: Up to 6 months
Secondary Outcome
- Change of pain over timeDetermined 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.Timeframe: Up to 6 months from baseline
- Change in bone pain related quality of lifeAs 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) questionnaireTimeframe: Up to 6 months from baseline
- Pain control rateAs 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.Timeframe: Up to 6 months
- Pain progression rateAs 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.Timeframe: Up to 6 months
- Time to first pain progressionDefined as the time between the first injection of Radium-223 until an increase in the BPI-SF worst pain item by at least two pointsTimeframe: Up to 6 months
- Time to first opioid useTimeframe: Up to 5.5 years
- Summary description of covariates on pain responseThe 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, BSITimeframe: Up to 6 months
- Relation between bone uptake in known lesions and pain palliationOnly in patients with bone scan prior to start of treatment and a second scan during or within 6 weeks after end of Radium-223 treatmentTimeframe: Up to 6 months
- Dosage of Radium-223Timeframe: Up to 5 months
- Number of injections of Radium-223Timeframe: Up to 5 months
- Course of blood count presented as percentage of patients below limit for further injections according to the local product informationTimeframe: Up to 5 months
- Number of participants with Treatment-emergent Adverse Events (TEAE)Timeframe: 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 treatmentTimeframe: 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 interventionTimeframe: Up to 5.5 years
- Overall survivalDefined 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.Timeframe: 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 OSTimeframe: Up to 6 months
- Effect of concomitant drug treatment on pain, quality of life, and overall survivalExploration of the influence of abiraterone, enzalutamide, opioids and denosumab on OS by number of injections (5-6 vs. 1-4)Timeframe: Up to 5.5 years
- Time from castration resistance to treatment with Radium-223Time from verified castration resistance to first injection of Radium-223Timeframe: First treatment
- Description of covariates on duration of therapyDescription of covariates on duration of therapy (to get ≥ 5 injections versus ≤ 4 injections) of mCRPC patients during treatment with Radium-223.Timeframe: 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)Timeframe: Up to 6 months
- Incidence of pathological fractures, non-pathological fractures and bone associated events during treatment and follow upTimeframe: Up to 5.5 years
Additional Information
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