check_circleStudy Completed
Prostate Cancer, Castration resistant
Bayer Identifier:
19863
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Multi-academic center study of Xofigo patients
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.
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.
Key Participants Requirements
Sex
MaleAge
18 - N/ATrial summary
Enrollment Goal
150Trial Dates
December 2018 - October 2019Phase
N/ACould I Receive a placebo
NoProducts
Xofigo (Radium-223 dichloride, BAY88-8223)Accepts Healthy Volunteer
NoWhere to participate
| Status | Institution | Location |
|---|---|---|
Completed | Bayer US | Whippany, 07981, United States |
Primary Outcome
- Overall survivalSurvival will be measured from initiation of first line therapy after mCRPC diagnosis until the date of death (from any cause).date_rangeTime Frame: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 interventiondate_rangeTime Frame:Up to 30 months
- Reasons for treatment discontinuationdata for treatment discontinuation for each mCRPC therapy will be collecteddate_rangeTime Frame: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 docetaxeldate_rangeTime Frame:Up to 30 months
- Treatments receivedmeasured as Yes/Nodate_rangeTime Frame:Up to 30 months
- Number of hospitalizationsalong with the discharge diagnosis, as recorded in medical charts or discharge summariesdate_rangeTime Frame: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))date_rangeTime Frame:Up to 30 months
- Non-laboratory based clinically relevant safety outcomesdocumented in medical recordsdate_rangeTime Frame:Up to 30 months
- hospital length of staydate_rangeTime Frame:Up to 30 months
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A