Trial Condition(s):
Metastatic castration-resistant prostate cancer
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)
Bayer Identifier:
20437
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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).
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations database study database study, Sweden | Status Completed | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
A randomized, controlled, partial-blind, parallel-group study evaluating the effect of oral administration of BAY 1834845 and BAY 1830839 twice daily for 7 consecutive days on local and systemic IRAK4 pathway-related challenges in healthy male participants
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
2
Primary Outcome
- Bone fractures requiring admission to a hospital or treated in an outpatient setting, as recorded or captured in the PCBaSePCBaSe: Prostate Cancer data Base SwedenTimeframe: Retrospectively analysis from November 2013 to December 2018
Secondary Outcome
- Death due to all causesTimeframe: Retrospectively analysis from November 2013 to December 2018
- Death due to prostate cancerTimeframe: Retrospectively analysis from November 2013 to December 2018
Additional Information
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