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NCT04256993 Clinical Trial

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

Metastatic Castration-Resistant Prostate Cancer Clinical Trial

— PRECISE  

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04256993
Other study ID # 20437
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 15, 2020
Est. completion date June 1, 2021

Study information
Verified date January 2024
Source Bayer
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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).

Recruitment information / eligibility
Status Completed
Enrollment 1434
Est. completion date June 1, 2021
Est. primary completion date June 1, 2021
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Sweden Database Study Database Study

Sponsors (1)
Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Death due to all causes Retrospectively analysis from November 2013 to December 2018
Secondary Death due to prostate cancer Retrospectively analysis from November 2013 to December 2018
See also
  Status Clinical Trial Phase
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Recruiting NCT05489211 - Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03) Phase 2
Terminated NCT05489991 - A Study of TmPSMA-02 Chimeric Antigen Receptor (CAR) T-cells in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC) Phase 1/Phase 2
Active, not recruiting NCT05521412 - EValuation of radIOLigand Treatment in mEn With Metastatic Castration-resistant Prostate Cancer With [161Tb]Tb-PSMA-I&T Phase 1/Phase 2
Terminated NCT04556617 - PLX2853 in Combination With Abiraterone Acetate and Prednisone and in Combination With Olaparib in Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC) Phase 1/Phase 2
Completed NCT02125357 - Sequencing Abiraterone and Enzalutamide in mCRPC Phase 2
Recruiting NCT06052306 - A Study to Learn How Safe the Study Treatment Actinium-225-macropa-pelgifatamab (BAY3546828) is, How it Affects the Body, How it Moves Into, Through and Out of the Body, and About Its Anticancer Activity in Men With Advanced Metastatic Castration-resistant Prostate Cancer (mCRPC) Phase 1
Recruiting NCT05917470 - A Clinical Study of ONCT-534 in Subjects With Metastatic Castration-resistant Prostate Cancer. Phase 1/Phase 2
Recruiting NCT05519449 - Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01) Phase 1
Terminated NCT05301062 - A Research Called CREDIT Studies How Safe the Study Treatment Radium-223 is and How Well it Works in Chinese Men With Advanced Prostate Cancer That Has Spread to the Bones and Does Not Respond to Treatments for Lowering Testosterone Levels
Recruiting NCT05383079 - Combination of Radium-223 and Lutetium-177 PSMA-I&T in Men With Metastatic Castration-Resistant Prostate Cancer Phase 1/Phase 2
Active, not recruiting NCT04060394 - Dose-Escalation and Efficacy Study of LAE001/Prednisone Plus Afuresertib Patients With m-CRPC Phase 1/Phase 2
Completed NCT01942837 - Study of Enzalutamide in Patients With Castration-resistant Prostate Cancer Phase 2
Recruiting NCT05458544 - [Lu-177]Ludotadipep in Castration-resistant Prostate Cancer(CRPC): Investigation of Drug and Application Phase 1/Phase 2
Withdrawn NCT04879589 - Phase 1 Study of ATRS-2002 in Healthy Male Adults Phase 1
Recruiting NCT03230734 - Sequencing of Radium-223 and Docetaxel in Symptomatic Bone-only Metastatic Castration-resistant Prostate Cancer Phase 2
Recruiting NCT05116579 - Circulating Tumor DNA (ctDNA) Monitoring in the Assessment and Prediction of the Efficacy of PARP Inhibitors (PARPi)
Active, not recruiting NCT03732820 - Study on Olaparib Plus Abiraterone as First-line Therapy in Men With Metastatic Castration-resistant Prostate Cancer Phase 3
Recruiting NCT05005728 - XmAb®20717 (Vudalimab) Alone or in Combination With Chemotherapy or Targeted Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer Phase 2
Recruiting NCT05762536 - Docetaxel or Cabazitaxel With or Without Darolutamide in mCRPC Phase 2

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