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 (PRECISE)

Rates of Bone Fractures and Survival in Metastatic Castration-resistant PRostate Cancer (mCRPC) 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).

Study Overview

• Status: Completed
• Conditions: Metastatic Castration-Resistant Prostate Cancer
• Intervention / Treatment: Drug: Radium-223 dichloride (Xofigo, BAY88-8223); Drug: Other standard care

• Study Type: Observational
• Enrollment (Actual): 1434

Contacts and Locations

Study Locations

• Sweden
  • Database Study, Sweden
    • Database Study

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population comprises men with mCRPC in the PPC (Patient-overview Prostate Cancer) PCBaSe data set during the study time frame, with the potential addition of men with mCRPC in the Karolinska Institutet data sets.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ra-223 initiators; Patients diagnosed with mCRPC (Metastatic Castration-Resistant Prostate Cancer) who start treatment with Ra-223. Patients will be identified from the "Patient-overview Prostate Cancer" (PPC), a sub-registry of the Prostate Cancer data Base Sweden (PCBaSe) data set.	Drug: Radium-223 dichloride (Xofigo, BAY88-8223); Follow the physician's prescription in routine clinical practice. This study does not involve prescription of the drugs.
Initiators of other standard of care; The comparator cohort will be patients using standard of care other than Ra-223.	Drug: Other standard care; Docetaxel, cabazitaxel, enzalutamide, abiraterone and others standard of care following the physician's prescription in routine clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Retrospectively analysis from November 2013 to December 2018

Secondary Outcome Measures

Outcome Measure	Time Frame
Death due to all causes	Retrospectively analysis from November 2013 to December 2018
Death due to prostate cancer	Retrospectively analysis from November 2013 to December 2018

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here to find results for studies related to Bayer products

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2020
• Primary Completion (Actual): June 1, 2021
• Study Completion (Actual): June 1, 2021

Study Registration Dates

• First Submitted: February 4, 2020
• First Submitted That Met QC Criteria: February 4, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Estimated): January 15, 2024
• Last Update Submitted That Met QC Criteria: January 12, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Prostate cancer; Overall survival; Bone fractures; Prostate cancer metastatic
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Wounds and Injuries; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms; Fractures, Bone; Antineoplastic Agents; Radium Ra 223 dichloride
• Other Study ID Numbers: 20437

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No