Effects of Prostate Cancer on Brain Function

Prostate Cancer Clinical Trial

Official title:

The Effects of Prostate Cancer on Brain Function: a Prospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05737004
• Other study ID #: EF2023-01
• Status: Recruiting
• Start date: April 13, 2023
• Est. completion date: April 1, 2024

Study information

• Verified date: April 2023
• Source: Shanghai East Hospital
• Contact: Shuaidong Wang
• Phone: 15102100859
• Email: wangshuaidong_wsd[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: April 1, 2024
• Est. primary completion date: February 12, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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;

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Diagnostic Test:
• functional magnetic resonance imaging examination?Zung Self Rating Anxiety Scale and Beck Depression Inventory-II
fMRI examination ?Zung Self Rating Anxiety Scale and Beck Depression Inventory-II were performed in these patients within 1 week before biopsy .

Locations

Country	Name	City	State
China	Shanghai East Hospital, Tongji University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai East Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The evaluation of Magnetic Resonance(MR)	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.	Within 1 week before biopsy
Secondary	Assessment of anxiety status	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.	Within 1 week before biopsy
Secondary	Assessment of depressive status	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.	Within 1 week before biopsy