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NCT Number: NCT04256993

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

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).

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Key information

Conditions

Metastatic Castration-resistant Prostate Cancer Fractures, Bone Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms Wounds and Injuries

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Database Study

Database Study, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Prior use of Ra-223
  • Patients that have participated in a Ra-223 RCT

Treatment and study plan

Radium-223 dichloride (Xofigo, BAY88-8223)

Drug

Follow the physician's prescription in routine clinical practice. This study does not involve prescription of the drugs.

Other standard care

Drug

Docetaxel, cabazitaxel, enzalutamide, abiraterone and others standard of care following the physician's prescription in routine clinical practice.

Primary outcomes

  1. Bone fractures requiring admission to a hospital or treated in an outpatient setting, as recorded or captured in the PCBaSe

    Time frame: Retrospectively analysis from November 2013 to December 2018

    PCBaSe: Prostate Cancer data Base Sweden

Secondary outcomes

  1. Death due to all causes

    Time frame: Retrospectively analysis from November 2013 to December 2018

  2. Death due to prostate cancer

    Time frame: Retrospectively analysis from November 2013 to December 2018

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Rates of Bone Fractures and Survival in Metastatic Castration-resistant PRostate Cancer (mCRPC) PatiEnts Treated With Radium 223 in Routine Clinical practIce in SwedEn

Acronym: PRECISE

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 5, 2020
Registry last updated
Jan 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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