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

Metastatic Hormone-Sensitive Prostate Cancer Clinical Trial

Official title:

A Non-Interventional, Modified Delphi Study to Establish Consensus Recommendations on the Optimal Management of Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) Patients in South Korea

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06452212
• Other study ID #: 9785-MA-3541
• Status: Not yet recruiting
• Start date: July 31, 2024
• Est. completion date: September 30, 2024

Study information

• Verified date: June 2024
• Source: Astellas Pharma Inc
• Contact: Astellas Pharma Korea, Inc.
• Phone: +82 -2-3448-0504
• Email: Astellas.registration[@]astellas.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypersensitivity
• Metastatic Hormone-Sensitive Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• No Intervention
No investigational drug will be administered to participants in this study.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Korea, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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