check_circleStudy Completed

Metastatic Castration-Resistant Prostate Cancer

Bayer Identifier:

20437

ClinicalTrials.gov Identifier:

NCT04256993

EudraCT Number:

Not Available

EU CT Number:

Not Available
PRECISE, a study to gather more information about bone fractures and survival in castration-resistant PRostate cancer (CRPC) patiEnts treated with radium-223 in routine Clinical practIce in SwedEn

Trial purpose

In this observational study researchers want to gather more information about bone fractures and survival in castration-resistant prostate cancer (CRPC) patients treated with radium-223 in routine clinical practice in Sweden. The goal is to estimate the proportion of new cases (incidence) of symptomatic bone fractures and to estimate the proportion of death occurred in years of observation time per person (person years). Radium-223 (Ra-223) is an alpha particle-emitting radioactive agent approved for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC).

Key Participants Requirements

Sex

Male

Age

18 - N/A
  • - Histologically confirmed adenocarcinoma of the prostate, i.e., the patient is registered in the NPCR (histology other than adenocarcinomas are not registered in the NPCR).
    - Start of Ra-223 treatment for mCRPC as an n-th line of treatment, where "n" goes from 1 to 4.
    - ECOG performance status of 0-2 at treatment initiation. We will assume that patients starting any of the systemic therapies under study have a performance status of 0-2.
  • - Prior use of Ra-223
    - Patients that have participated in a Ra-223 RCT

Trial summary

Enrollment Goal
1434
Trial Dates
February 2020 - June 2021
Phase
Phase 4
Could I Receive a placebo
No
Products
Xofigo (Radium-223 dichloride, BAY88-8223)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
database studydatabase study, Sweden

Primary Outcome

  • Bone fractures requiring admission to a hospital or treated in an outpatient setting, as recorded or captured in the PCBaSe
    PCBaSe: Prostate Cancer data Base Sweden
    date_rangeTime Frame:
    Retrospectively analysis from November 2013 to December 2018

Secondary Outcome

  • Death due to all causes
    date_rangeTime Frame:
    Retrospectively analysis from November 2013 to December 2018
  • Death due to prostate cancer
    date_rangeTime Frame:
    Retrospectively analysis from November 2013 to December 2018

Trial design

Rates of bone fractures and survival in metastatic castration-resistant PRostate cancer (mCRPC) PatiEnts treated with Radium 223 in routine Clinical practIce in SwedEn
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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