Effects of Prostate Cancer on Brain Function

Sponsor
Shanghai East Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05737004
Collaborator
(none)
250
1
13.6
18.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: functional magnetic resonance imaging examination and functional assessment of cancer therapy-prostate(FACT--P) questionnaire

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 Design

Study Type:
Observational
Anticipated Enrollment :
250 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Effects of Prostate Cancer on Brain Function: a Prospective Cohort Study
Anticipated Study Start Date :
Feb 13, 2023
Anticipated Primary Completion Date :
Feb 12, 2024
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Prostate cancer group

Prostate cancer was confirmed by biopsy, and fMRI examination and functional assessment of cancer therapy-prostate(FACT--P) questionnaire evaluation were performed in these patients within 1 week before biopsy and at 1, 3 months after biopsy.

Diagnostic Test: functional magnetic resonance imaging examination and functional assessment of cancer therapy-prostate(FACT--P) questionnaire
fMRI examination and functional assessment of cancer therapy-prostate(FACT--P) questionnaire were performed in these patients within 1 week before biopsy and at 1, 3 months after biopsy.

Non-Prostate cancer group

Non-Prostate cancer was confirmed by biopsy, and fMRI examination and functional assessment of cancer therapy-prostate(FACT--P)questionnaire evaluation were performed in these patients within 1 week before biopsy and at 1, 3 months after biopsy.

Diagnostic Test: functional magnetic resonance imaging examination and functional assessment of cancer therapy-prostate(FACT--P) questionnaire
fMRI examination and functional assessment of cancer therapy-prostate(FACT--P) questionnaire were performed in these patients within 1 week before biopsy and at 1, 3 months after biopsy.

Outcome Measures

Primary Outcome Measures

  1. The evaluation of Magnetic Resonance(MR) [Within 1 week before biopsy and at 1, 3months after 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

  1. Assessment of anxiety status [Within 1 week before biopsy and at 1, 3months after biopsy]

    Zung Self Rating Anxiety Scale was used to assess anxiety status.

  2. Assessment of depressive status [Within 1 week before biopsy and at 1, 3months after biopsy]

    Beck Depression Inventory-II was used to assess depressive status.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
Male
Accepts 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;

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shanghai East Hospital, Tongji University School of Medicine Shanghai Shanghai China 200120

Sponsors and Collaborators

  • Shanghai East Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shanghai East Hospital
ClinicalTrials.gov Identifier:
NCT05737004
Other Study ID Numbers:
  • EF2023-01
First Posted:
Feb 21, 2023
Last Update Posted:
Feb 21, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Shanghai East Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 21, 2023