Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2026-02-26 @ 3:16 AM
Study NCT ID:
NCT03315260
Status:
COMPLETED
Last Update Posted:
2024-02-08
First Post:
2017-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment Satisfaction With Ra-223 in Japan
Sponsor:
Bayer
Organization:
Study Overview
Official Title:
Treatment Satisfaction With Ra-223 Among Japanese Castration Resistant Prostate Cancer (CRPC) Patients
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to answer the research question: Are Japanese bone metastatic CRPC patients satisfied with their Ra-223 treatment, and what factors drive such satisfaction? It also aims to determine patient anxiety regarding prostate cancer while on treatment with Ra-223, and assess the effect on quality of life.
Detailed Description:
This is a local, Japanese, prospective, longitudinal, observational, company-sponsored, multi-center, single arm study that will describe treatment satisfaction with Ra-223 in 150 bone metastatic CRPC patients on 1st to 3rd line CRPC therapy. All outcomes will be obtained using PRO questionnaires at 4 time points: before treatment, during treatment, and at 1-month after the last treatment cycle.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: