stop_circleTerminated/Withdrawn

Prostatic Neoplasms, Castration-Resistant

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

Male

Age

40 - N/A

Trial summary

Enrollment Goal
0
Trial Dates
October 2017 - September 2018
Phase
N/A
Could I Receive a placebo
No
Products
Xofigo (Radium-223 dichloride, BAY88-8223)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Withdrawn
Many LocationsWhippany, 07981, United States

Primary Outcome

  • Survival rates
    Survival 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 subjects
    date_rangeTime Frame:
    Up to 1 year

Secondary Outcome

  • Disease progression
    Disease progression will be defined as either of the below: PSA (Prostate Specific Antigen) progression ALP (Alkaline Phosphatase) progression Symptomatic progression Radiographic progression
    date_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 bone
    date_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 intervention
    date_rangeTime Frame:
    Up to 1 year
  • Time to death
    date_rangeTime Frame:
    Up to 1 year
  • Sequence of treatment regimens
    date_rangeTime Frame:
    Up to 1 year
  • Dose schedule
    date_rangeTime Frame:
    Up to 1 year
  • Duration of therapy
    date_rangeTime Frame:
    Up to 1 year
  • Time to first visceral metastasis
    date_rangeTime Frame:
    Up to 1 year
  • Proportion of patients developing visceral metastasis
    date_rangeTime Frame:
    Up to 1 year

Trial design

Outcomes and Treatment Patterns of Metastatic Castration Resistant Prostate Cancer (mCRPC) patients treated with Radium-223 concomitantly with Abiraterone or Enzalutamide in first line setting : A retrospective chart abstraction study
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A