Non-Interventional Study to Establish Consensus on Manage... | NCT06452212

Studies
Non-Interventional Study to Establish Consensus on Management of Metastatic Hormone-Sensitive Prostate Cancer Patients

NCT06452212

Sponsor

Astellas Pharma Korea, Inc.

Status

Completed

Last Update Posted

Nov 21, 2024Actual

Enrollment

23Actual

Phase

Not provided

Conditions

Metastatic Hormone-Sensitive Prostate Cancer

Interventions

No Intervention

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 10, 2024Actual

Primary Completion Date

Jul 29, 2024Actual

Completion Date

Jul 29, 2024Actual

First Submitted Date

Jun 5, 2024

First Submission Date that Met QC Criteria

Jun 5, 2024

First Posted Date

Jun 11, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 19, 2024

Last Update Posted Date

Nov 21, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to establish an expert consensus recommendations on managing patients with mHSPC in South Korea, and to provide clinicians with a comprehensive guide to support their clinical decision making. There are no secondary objectives for this study.

Detailed Description

Data collection for this study will be conducted through 2 rounds of web-based surveys of health care professionals (HCPs). A meeting with the panelists will be held as a 3rd round if a consensus for pre determined key questions is not achieved after the 2 rounds of the survey.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

23Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Urologists		Health care professionals/panelist.	Other: No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No Intervention	Other	No investigational drug will be administered to participants in this study.	Urologists

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Treatment plans for patients with mHSPC	Treatment plans for patients with mHSPC within the local healthcare environment will be collected via online surveys and a consensus meeting will be held if required.	Up to 7 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Urologist from university hospitals in South Korea.
Has a minimum 10 years of practice experience (experience as a military or public health doctor could be considered practice experience)
Sees a minimum of 50 mHSPC patients in a year.
At least 10 publications in SCIE (Science Citation Index Expanded) journals in the past 5 years.

Exclusion Criteria:

Urologist in private practice.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Target recruitment of 25 urologists will be recruited with an acceptable goal of 20 as panelists from university hospitals in South Korea.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Medical Director	Astellas Pharma Korea, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
KR82001		Seoul			South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014571	Urologic Neoplasms

Ancestor Terms

ID	Term
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided