stop_circleTerminated/Withdrawn
Prostatic Neoplasms, Castration-Resistant
Bayer Identifier:
19706
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Outcomes of mCRPC patients treated with Ra-223 concomitant with abiraterone or enzalutamide- A chart review study
Trial purpose
There are no real-world data that describes how Radium-223 (Ra-223) is being used in combination with abiraterone/enzalutamide (abi/enza) or evidence describing outcomes of this combination usage for the treatment of metastatic castration resistant prostate cancer (mCRPC). To address these data gaps a cohort of mCRPC patients will be chosen who received Ra-223 concomitant with abi/enza in first line therapy to assess the treatment patterns following first line and clinical outcomes from initiation of first line treatment. For the purpose of this study concomitant use will be defined as Ra-223 initiated after at least 6 months from the start of first line abi/enza. The specific objectives of the study are to describe the outcomes, treatment patterns, patient and provider characteristics of mCRPC patients treated with Ra-223 concomittantly with abi/enza in first line treatment.
Key Participants Requirements
Sex
MaleAge
40 - N/ATrial summary
Enrollment Goal
0Trial Dates
October 2017 - September 2018Phase
N/ACould I Receive a placebo
NoProducts
Xofigo (Radium-223 dichloride, BAY88-8223)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Withdrawn | Many Locations | Whippany, 07981, United States |
Primary Outcome
- Survival ratesSurvival will be defined as time from initiation of first line therapy until death. Survival will be measured as the proportion of study subjects that are alive at the data cut-off or median time for survival of at least 50% of study subjectsdate_rangeTime Frame:Up to 1 year
Secondary Outcome
- Disease progressionDisease progression will be defined as either of the below: PSA (Prostate Specific Antigen) progression ALP (Alkaline Phosphatase) progression Symptomatic progression Radiographic progressiondate_rangeTime Frame:Up to 1 year
- Skeletal related events (SRE)SRE will be defined as: a pathologic fracture, spinal cord compression, necessity for radiation to bone for pain or impending fracture and/or surgery to bonedate_rangeTime Frame:Up to 1 year
- Symptomatic Skeletal Events (SSE)SSE defined as external beam radiation therapy (EBRT) to relieve skeletal symptoms, new symptomatic pathologic bone fracture, occurrence of spinal cord compression, or tumor-related orthopedic surgical interventiondate_rangeTime Frame:Up to 1 year
- Time to deathdate_rangeTime Frame:Up to 1 year
- Sequence of treatment regimensdate_rangeTime Frame:Up to 1 year
- Dose scheduledate_rangeTime Frame:Up to 1 year
- Duration of therapydate_rangeTime Frame:Up to 1 year
- Time to first visceral metastasisdate_rangeTime Frame:Up to 1 year
- Proportion of patients developing visceral metastasisdate_rangeTime Frame:Up to 1 year
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A