Effects of Prostate Cancer on Brain Function

April 16, 2023 updated by: Shanghai East Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200120
        • Recruiting
        • Shanghai East Hospital, Tongji University School of Medicine
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The patient coming to our hospital for prostate biopsy and fully understand the clinical trial protocol and sign informed consent

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Prostate cancer group
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 .
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 .
Non-Prostate cancer group
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 .
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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The evaluation of Magnetic Resonance(MR)
Time Frame: 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.
Within 1 week before biopsy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of anxiety status
Time Frame: 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.
Within 1 week before biopsy
Assessment of depressive status
Time Frame: 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.
Within 1 week before biopsy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai East Hospital

Investigators

  • Principal Investigator: Haifeng Wang, Shanghai East Hospital,Tongji University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 13, 2023

Primary Completion (Anticipated)

February 12, 2024

Study Completion (Anticipated)

April 1, 2024

Study Registration Dates

First Submitted

February 12, 2023

First Submitted That Met QC Criteria

February 12, 2023

First Posted (Actual)

February 21, 2023

Study Record Updates

Last Update Posted (Actual)

April 19, 2023

Last Update Submitted That Met QC Criteria

April 16, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EF2023-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Once available, the results of this trial will be disseminated to an international peer-reviewed journal and presentations at international or national academic conferences. The data will be made available upon request to researchers a) who provide a methodologically sound proposal and b) whose proposed use of the data has been approved by an independent ethical review committee.

IPD Sharing Time Frame

Data will become available after publication with no end date

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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