stop_circleTerminated/Withdrawn

Prostatic Neoplasms, Castration-Resistant

Bayer Identifier:

19706

ClinicalTrials.gov Identifier:

NCT03325127

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

Male

Age

40 - N/A
  • - Diagnosis of mCRPC and bone metastases
    - ≥ 40 years of age at diagnosis of mCRPC
    - Initiated first line treatment for mCRPC with abi/enza (use of sipuleucel-T prior to initiation of abi or enza is allowed)
    - Receipt of at least one cycle of radium-223 after 15 May 2013
    - First cycle of Ra-223 occurs while receiving first line treatment with abi/enza
    - Treated with abi/enza for at least 28 days (1 cycle) following initiation of Ra-223
    - Initiation of Ra-223 at least 6 months after the start of treatment with abi/enza
    - Completion of Ra-223 treatment prior to the receipt of any chemotherapy for mCRPC
    - At least 12 months of follow-up (or until death) from date of initiation of Ra-223
    - Known date of death (if patient deceased)
  • - Receipt of any prior chemotherapy during hormone sensitive disease or any time before mCPRC
    - Active participant in an interventional clinical trial for CRPC in first line
    - Presence of visceral metastases at initiation of Ra-223 treatment
    - Treated with abi/enza (with or without docetaxel) prior to the development of metastatic and/or castration resistant disease

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