Single Center Registration Study on HER2 Expression and Clinical Pathological Characteristics in Prostate Cancer

Recruiting

• Conditions: HER2 Expression and Clinical Pathological Characteristics in Prostate Cancer
• Interventions: Diagnostic Test: Collect HER2 expression in prostate cancer patients

• Registration Number: NCT06146114
• Lead Sponsor: Qilu Hospital of Shandong University

Brief Summary

This study is a single center, non-interference, retrospective registration study: HER2 testing and disease information collection were conducted on patients diagnosed with prostate cancer and able to obtain tumor tissue in our hospital from January 2018 to July 2023. Statistical analysis was conducted on the collected information to analyze the expression of HER2 in Chinese prostate patients and the correlation between HER2 and disease type.

Detailed Description

1. To explore the expression of HER2 protein in prostate cancer patients admitted to Qilu Hospital of Shandong University, especially the expression rate of HER2 protein under different pathological characteristics (age, TNM grade, primary and metastasis), and to explore the correlation between HER2 protein expression level, efficacy, and prognosis based on patient clinical information.

2. (1) Main Purpose

Analyze the expression of HER2 in prostate cancer patients admitted to Qilu Hospital of Shandong University.

(2) Secondary purpose

The expression of HER2 protein under different clinical and pathological characteristics (age, TNM grade, primary, and metastasis).

3.Main indicators:

The expression of HER2 in prostate cancer patients.

Secondary indicators:

1. The correlation between HER2 expression (IHC0/1+/2+/3+) and disease characteristics in locally advanced or metastatic prostate cancer patients;

2. The distribution of HER2 expression in different ages, different parts, different degrees of differentiation, and different TNM stages; Evaluate the expression of primary and metastatic lesions in patients with metastasis

Study Timeline

• Study Start: 2023-07-01
• Status Verified: 2023-11
• Study First Submitted: 2023-11-17
• Study First Submitted QC: 2023-11-17
• Last Update Submitted: 2023-11-17
• Study First Posted: 2023-11-24
• Last Update Posted: 2023-11-24
• Primary Completion: 2024-05-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 100

Inclusion Criteria

• 1. Prostate cancer patients confirmed by histopathology in our hospital from January 2018 to July 2023;

  2. Men aged ≥ 18 years old;

  3. The expected survival time is greater than 12 weeks;

  4. The KPS functional status score is greater than 60, and the ECOG status score is 0-2 points;

  5. The subjects voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up.

Exclusion Criteria

• 1. Those who have been diagnosed with tumors in other parts, such as lung cancer, liver cancer, stomach cancer, colorectal cancer, breast cancer, etc. (except for cancer in situ or non melanoma skin cancer, or combined tumors with low recurrence probability within a few years);

2. According to the researcher's judgment, there are other patients who are not suitable for inclusion.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
experimental group	Collect HER2 expression in prostate cancer patients	1. Prostate cancer patients confirmed by histopathology in our hospital from January 2018 to July 2023; 2. Men aged ≥ 18 years old; 3. The expected survival time is greater than 12 weeks; 4. The KPS functional status score is greater than 60, and the ECOG status score is 0-2 points; 5. The subjects voluntarily joined this study, signed an informed consent form, had good compliance, and cooperated with follow-up.

Primary Outcome Measures

Name	Time	Method
HER2 expression in prostate cancer patients	18 months	HER2 test results

Secondary Outcome Measures

Name	Time	Method
Correlation between HER2 expression (IHC0/1+/2+/3+) and disease characteristics in locally advanced or metastatic prostate cancer patients	18 months
The distribution of HER2 expression in different ages, different parts, different degrees of differentiation, and different TNM stages;	18 months

Trial Locations

Locations (1)

Qilu hospital; 🇨🇳 Jinan, Shandong, China