NCT05737004

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 21, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

April 13, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

April 19, 2023

Status Verified

April 1, 2023

Enrollment Period

10 months

First QC Date

February 12, 2023

Last Update Submit

April 16, 2023

Conditions

Prostate Cancer

Keywords

prostate cancerfunctional magnetic resonance imaging(fMRI)Brain function

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Assessment of anxiety status

    Within 1 week before biopsy

  • Assessment of depressive status

    Within 1 week before biopsy

Study Arms (2)

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

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

Interventions

functional magnetic resonance imaging examination、Zung Self Rating Anxiety Scale and Beck Depression Inventory-IIDIAGNOSTIC_TEST

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 groupProstate cancer group

Eligibility Criteria

Age18 Years - 80 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Between the ages of 18 and 80
  • Patients with prostate biopsy;
  • No history of other malignant tumors;
  • Exclude other malignant tumors;
  • Fully understand the clinical trial protocol and sign informed consent;

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai East Hospital, Tongji University School of Medicine

Shanghai, Shanghai Municipality, 200120, China

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Haifeng Wang

    Shanghai East Hospital,Tongji University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shuaidong Wang

CONTACT

15102100859wangshuaidong_wsd@163.com

Haifeng Wang

CONTACT

13681750891446720864@qq.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2023

First Posted

February 21, 2023

Study Start

April 13, 2023

Primary Completion

February 12, 2024

Study Completion

April 1, 2024

Last Updated

April 19, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Data will become available after publication with no end date

Locations

CN(1)