Effects of Prostate Cancer on Brain Function

Recruiting

• Conditions: Prostate Cancer
• Interventions: Diagnostic Test: functional magnetic resonance imaging examination、Zung Self Rating Anxiety Scale and Beck Depression Inventory-II

• Registration Number: NCT05737004
• Lead Sponsor: Shanghai East Hospital

Brief Summary

To explore whether the patients with prostate cancer have functional changes in specific brain areas and changes in psychological and mental characteristics compared with the patients without prostate cancer.

Detailed Description

This study was intended to observe the functional changes of brain fMRI in patients with and without prostate cancer enrolled in the cohort of patients who planned to undergo prostate biopsy, in an attempt to discover specific brain region changes in patients with prostate cancer, and lay a foundation for further clarifying the relationship and mechanism between brain region function changes and prostate cancer.

Study Timeline

• Study First Submitted: 2023-02-12
• Study First Submitted QC: 2023-02-12
• Study First Posted: 2023-02-21
• Status Verified: 2023-04
• Study Start: 2023-04-13
• Last Update Submitted: 2023-04-16
• Last Update Posted: 2023-04-19
• Primary Completion: 2024-02-12
• Study Completion: 2024-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 250

Inclusion Criteria

1. Between the ages of 18 and 80
2. Patients with prostate biopsy;
3. No history of other malignant tumors;
4. Exclude other malignant tumors;
5. Fully understand the clinical trial protocol and sign informed consent;

Exclusion Criteria

1. magnetic resonance contraindications;
2. symptomatic acute or chronic inflammation of the prostate;
3. Patients with brain trauma or brain disease;
4. Patients who have died of other malignancies in the past or are currently suffering from other malignancies;
5. Patients judged by the investigator to be unfit to participate in the clinical trial;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prostate cancer group	functional magnetic resonance imaging examination、Zung Self Rating Anxiety Scale and Beck Depression Inventory-II	Prostate cancer was confirmed by biopsy, and fMRI examination 、Zung Self Rating Anxiety Scale and Beck Depression Inventory-II were performed in these patients within 1 week before biopsy .
Non-Prostate cancer group	functional magnetic resonance imaging examination、Zung Self Rating Anxiety Scale and Beck Depression Inventory-II	Non-Prostate cancer was confirmed by biopsy, and fMRI examination 、 Zung Self Rating Anxiety Scale and Beck Depression Inventory-II were performed in these patients within 1 week before biopsy .

Primary Outcome Measures

Name	Time	Method
The evaluation of Magnetic Resonance(MR)	Within 1 week before biopsy	To compare the differences in rs-fMRI measures (Amplitude of low frequency fluctuations , Regional Homogeneity and Functional Connectivity ) between prostate cancer group and Non-prostate cancer group.

Secondary Outcome Measures

Name	Time	Method
Assessment of depressive status	Within 1 week before biopsy	Beck Depression Inventory-II was used to assess depressive status.By comparing the final scores, a score of 50 or less is considered healthy and a score of 50 or more is considered abnormal.
Assessment of anxiety status	Within 1 week before biopsy	Zung Self Rating Anxiety Scale was used to assess anxiety status.By comparing the final score, less than or equal to 10 is considered healthy, and more than 10 is considered abnormal.

Trial Locations

Locations (1)

Shanghai East Hospital, Tongji University School of Medicine; 🇨🇳 Shanghai, Shanghai, China