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Effects of Prostate Cancer on Brain Function

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05737004
Enrollment
250
Registered
2023-02-21
Start date
2023-04-13
Completion date
2024-04-01
Last updated
2023-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

prostate cancer, functional magnetic resonance imaging(fMRI), Brain function

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.

Interventions

DIAGNOSTIC_TESTfunctional 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 .

Sponsors

Shanghai East Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
Yes

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;

Design outcomes

Primary

MeasureTime frameDescription
The evaluation of Magnetic Resonance(MR)Within 1 week before biopsyTo 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

MeasureTime frameDescription
Assessment of anxiety statusWithin 1 week before biopsyZung 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.
Assessment of depressive statusWithin 1 week before biopsyBeck 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.

Countries

China

Contacts

Primary ContactShuaidong Wang
wangshuaidong_wsd@163.com15102100859
Backup ContactHaifeng Wang
446720864@qq.com13681750891

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026