Prostate CancerNCT05737004
Effects of Prostate Cancer on Brain Function
An observational study of Prostate Cancer, run by Shanghai East Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- functional magnetic resonance imaging examination、Zung Self Rating Anxiety Scale and Beck Depression Inventory-II
- How many people
- 250 participants
- Where
- 1 siteChina
- Study dates
- 13 Apr 2023to 1 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The patient coming to our hospital for prostate biopsy and fully understand the clinical trial protocol and sign informed consent
Who may be able to join
- 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;
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai East Hospital, Tongji University School of Medicine
Shanghai, Shanghai Municipality, 200120
Shuaidong Wang, Master, 15102100859, wangshuaidong_wsd@163.com
Haifeng Wang, MD, 8613681750891, 446720864@qq.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- functional magnetic resonance imaging examination、Zung Self Rating Anxiety Scale and Beck Depression Inventory-II
- Keywords
- prostate cancer, functional magnetic resonance imaging(fMRI), Brain function
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 .
| Study group | Role | What they receive |
|---|---|---|
| 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 . Receives: 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 . Receives: Diagnostic Test: functional magnetic resonance imaging examination、Zung Self Rating Anxiety Scale and Beck Depression Inventory-II |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 1 week before biopsy
Secondary outcomes (2)
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.
Measured: Within 1 week before biopsy
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.
Measured: Within 1 week before biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start13 Apr 2023 (estimated)
- Primary completion12 Feb 2024 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai East Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Haifeng Wang, Principal investigator, Shanghai East Hospital of Tongji University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05737004
- Sponsor's protocol ID
- EF2023-01
- Status last verified
- Apr 2023
- First submitted
- 12 Feb 2023
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Prostate Cancer on Brain Function: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05737004
- Acronym / sponsor ID
- EF2023-01
- Conditions
- Prostate Cancer
- Keywords
- prostate cancer, functional magnetic resonance imaging(fMRI), Brain function
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Shanghai East HospitalUniversity, hospital or other
- Study start
- 13 Apr 2023 (estimated)
- Primary completion
- 12 Feb 2024 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 21 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prostate cancer group | – | Diagnostic Test: functional magnetic resonance imaging examination、Zung Self Rating Anxiety Scale and Beck Depression Inventory-IIProstate 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 . |
| Non-Prostate cancer group | – | Diagnostic Test: functional magnetic resonance imaging examination、Zung Self Rating Anxiety Scale and Beck Depression Inventory-IINon-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 . |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The patient coming to our hospital for prostate biopsy and fully understand the clinical trial protocol and sign informed consent
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (5 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| functional magnetic resonance imaging examination、Zung Self Rating Anxiety Scale and Beck Depression Inventory-IIfMRI examination 、Zung Self Rating Anxiety Scale and Beck Depression Inventory-II were performed in these patients within 1 week before biopsy . | Diagnostic test | Non-Prostate cancer group, Prostate cancer group |
Primary outcome
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.
2 secondary outcomes
Assessment of anxiety status
Time frame: Within 1 week before biopsy
Assessment of depressive status
Time frame: Within 1 week before biopsy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
- Individual participant dataSharing planned: Yes. 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.
Related trials for Prostate Cancer
RecruitingPhase 2
The COSMYC Trial (COmbined Suppression of MYC)
Metastatic Castration-resistant Prostate Cancer
Not yet recruitingPhase 3
A Study of JNJ-101556143 With Best Supportive Care in Participants With Metastatic Prostate Cancer
Prostatic Neoplasms
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingObservational study
PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan
Metastatic Prostate Cancer
RecruitingPhase 2
Relugolix and Enzalutamide in Combination With Radiation Therapy for the Treatment of Very High Risk Prostate Cancer, OPTIMAL Trial
Prostate Adenocarcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haifeng Wang principal investigator
Shanghai East Hospital of Tongji University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Shanghai East Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shuaidong Wang (15102100859, wangshuaidong_wsd@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The evaluation of Magnetic Resonance(MR) (time frame: Within 1 week before biopsy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2023.