Trial Condition(s):
Prostate Cancer, Castration resistant
Multi-academic center study of Xofigo patients
Bayer Identifier:
19863
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
The study will be conducted from a real-world perspective to describe treatment sequences involving radium-223 and chemotherapy in patients with metastatic castrate resistant prostate cancer (mCRPC) and assess overall survival (OS) associated with treatment sequences involving radium-223 and chemotherapy. While clinical trials of radium-223 has demonstrated a survival benefit in the treatment of mCRPC, both pre and post- docetaxel, study lacked exposure to second generation androgens and hence could not assess outcomes pre or post abiraterone or enzalutamide.
The specific objective of this study is to describe and compare the clinical outcomes between treatment sequences for patients with mCRPC where 1) radium-223 is used (alone or in combination with abiraterone or enzalutamide) prior to chemotherapy versus 2) radium-223 used after chemotherapy in the treatment of mCRPC. The secondary objectives are to describe the safety patterns of docetaxel use among mCRPC patients who received chemotherapy post radium-223.
Inclusion Criteria
- Received at least one dose of radium-223 after mCRPC diagnosis - Received at least one prescription or dose of chemotherapy for treatment of mCRPC
Exclusion Criteria
- No documented visceral metastasis at initiation of radium-223
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Bayer US Whippany, United States, 07981 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Trial Design
A Retrospective, Longitudinal Multi-Center Study of Radium-223 in Patients with Metastatic Castration-Resistant Prostate Cancer
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
2
Primary Outcome
- Overall survivalSurvival will be measured from initiation of first line therapy after mCRPC diagnosis until the date of death (from any cause).Timeframe: Up to 30 months
- Time to symtomatic skeletal event(SSE)Measured as the time from initiation of first-line therapy after mCRPC diagnosis until first SSE; for the exploratory analysis, measured as the time from initiation of radium-223 until first SSE. SSE will be identified based on the ALSYMPCA trial definition: first use of external-beam radiation therapy (EBRT) to relieve skeletal symptoms, new symptomatic pathologic vertebral or non-vertebral bone fractures, spinal cord compression, or tumor-related orthopedic surgical interventionTimeframe: Up to 30 months
- Reasons for treatment discontinuationdata for treatment discontinuation for each mCRPC therapy will be collectedTimeframe: Up to 30 months
Secondary Outcome
- Laboratory-based outcomes collected by questionnaireData will be collected as available from initiation of docetaxel until 3 months following last dose of docetaxelTimeframe: Up to 30 months
- Treatments receivedmeasured as Yes/NoTimeframe: Up to 30 months
- Number of hospitalizationsalong with the discharge diagnosis, as recorded in medical charts or discharge summariesTimeframe: Up to 30 months
- PSA PFSdefined as death or an increase above PSA nadir by ≥25% and ≥2 ng/mL (PCWG 2008 definition for Prostate specific antigen(PSA) Progression-free survival(PFS))Timeframe: Up to 30 months
- Non-laboratory based clinically relevant safety outcomesdocumented in medical recordsTimeframe: Up to 30 months
- hospital length of stayTimeframe: Up to 30 months
Additional Information
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