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

NCT ID: NCT04256993

Last Updated: 2024-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1434 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-15

Study Completion Date

2021-06-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Metastatic Castration-Resistant Prostate Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Radium-223 dichloride (Xofigo, BAY88-8223)

Intervention Type DRUG

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.

Other standard care

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Radium-223 dichloride (Xofigo, BAY88-8223)

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

Intervention Type DRUG

Other standard care

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Database Study

Database Study, , Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Sweden

Related Links

Access external resources that provide additional context or updates about the study.

http://clinicaltrials.bayer.com/

Click here to find results for studies related to Bayer products

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

20437

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Radium 223 Following Intermittent ADT
NCT02656563 WITHDRAWN PHASE2