Prostate CancerCMNDPCNCT05947188
Circulating Tumor Cells and mpMRI for Non-invasive Diagnosis of Prostate Cancer(CMNDPC)
A study testing prostate cancer diagnosis in people with Prostate Cancer, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
This trial is a prospective, multicentre, diagnostic study. This study aims to evaluation the early diagnostic ability of circulating tumor cells plus multimodal MRI for prostate cancer. Read more about this study
- Who is it for?
- Ages 50 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- prostate cancer diagnosis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 808 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2023to Dec 2024
- Phase
- Interventional
- 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 50 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- No family history of prostate cancer;
- men ≥ 50 years；
- tPSA level of 4-10 ng/ml, and fPSA/tPSA<0.16;
- tPSA level of >10 ng/ml；
- With abnomal mpMRI、PET/CT、TRUS or DRE;
- fully understand the clinical trial protocol and sign the informed consent;
Who cannot join
- Not meet all of the inclusion criteria or any single inclusion criteria；
- previous diagnosis of prostate carcinoma ;
- symptomatic of acute prostatitis;
- local anesthetic allergy patients;
- cannot tolerate prostate biopsy or has contraindication to biopsy;
- patients judged by the investigator to be unsuitable to participate in the clinical trial;
Trial locations and contacts
1 site in 1 country.
liang liang contact
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an
yang gao, 0086-029-85323473, gaoyangxjtu@126.com
About this study
Official title: A Prospective Multicenter Cohort Study for Non-invasive Diagnosis of Prostate Cancer: In Vivo Isolation of Circulating Tumor Cells Plus Multimodal MRI
This trial is a prospective, multicentre, diagnostic study. This study aims to evaluation the early diagnostic ability of circulating tumor cells plus multimodal MRI for prostate cancer.
Read the detailed description
This trial is a prospective, multicentre, diagnostic study. This study aims to evaluation the early diagnostic ability of circulating tumor cells plus multimodal MRI for prostate cancer.
We will enroll 808 men with clinical suspicion of prostate cancer due to higher level PSA（>4ng/ml）or other examination abnormal. All the participants will receive prostate biopsy，the circulating tumor cells（CTCs）will be detected before biopsy.
This study will evaluate the diagnostic ability of CTCs+MRI and CTCs+MRI+PSA，including sensitivity, specificity, predictive values, diagnostic accuracy and receiver operating curves（ROC）.
- Conditions
- Prostate Cancer
- Being tested
- prostate cancer diagnosis
- Keywords
- Circulating Tumor Cells, multimodal MRI, Prostate Cancer, Diagnosis
- Medical subject headings
- Prostatic Neoplasms, Neoplastic Cells, Circulating, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prostate cancer diagnosisOther
prostate cancer diagnosis
| Study group | Role | What they receive |
|---|---|---|
| Sample for Circulating Tumoral Cells | Experimental | Sampling of Circulating Tumoral Cells will be done Receives: Other: prostate cancer diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive predictive value of CTCs counts for prostate cancer
Evaluation the diagnostic ability of CTCs counts in caner and non-cancer. All patients were confirmed by pathology.
Measured: 12 weeks
Secondary outcomes (2)
Correlation between CTCs counts and PIRADS score
Diagnostic value of CTCs
Measured: 12 weeks
combined PIRADS score for cancer and non-cancer
Diagnostic value of CTCs
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start1 Nov 2023
- Primary completionMar 2024 (estimated)
- Study completionDec 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.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 808 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Tianjin Medical University Second Hospital, The First Affiliated Hospital with Nanjing Medical University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Affiliated Hospital of Nantong University, Wujin People's Hospital, Seventh Medical Center of PLA Army General Hospital, The First Affiliated Hospital of Soochow University
- Responsible party
- Sponsor
- Investigators
- yang gao, Study chair, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05947188
- Sponsor's protocol ID
- XJTU1AF2022LSL-010
- Acronym
- CMNDPC
- Status last verified
- Jun 2023
- First submitted
- 27 Jun 2023
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Cohort Study for Non-invasive Diagnosis of Prostate Cancer: In Vivo Isolation of Circulating Tumor Cells Plus Multimodal MRI
- ClinicalTrials.gov ID
- NCT05947188
- Acronym / sponsor ID
- CMNDPC / XJTU1AF2022LSL-010
- Conditions
- Prostate Cancer
- Keywords
- Circulating Tumor Cells, multimodal MRI, Prostate Cancer, Diagnosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 808 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Collaborators
- Tianjin Medical University Second Hospital, The First Affiliated Hospital with Nanjing Medical University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Affiliated Hospital of Nantong University, Wujin People's Hospital, Seventh Medical Center of PLA Army General Hospital, The First Affiliated Hospital of Soochow University
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 17 Jul 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.
This trial is a prospective, multicentre, diagnostic study. This study aims to evaluation the early diagnostic ability of circulating tumor cells plus multimodal MRI for prostate cancer.
Detailed description
This trial is a prospective, multicentre, diagnostic study. This study aims to evaluation the early diagnostic ability of circulating tumor cells plus multimodal MRI for prostate cancer.
We will enroll 808 men with clinical suspicion of prostate cancer due to higher level PSA（>4ng/ml）or other examination abnormal. All the participants will receive prostate biopsy，the circulating tumor cells（CTCs）will be detected before biopsy.
This study will evaluate the diagnostic ability of CTCs+MRI and CTCs+MRI+PSA，including sensitivity, specificity, predictive values, diagnostic accuracy and receiver operating curves（ROC）.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sample for Circulating Tumoral Cells | Experimental | Other: prostate cancer diagnosisSampling of Circulating Tumoral Cells will be done |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- No family history of prostate cancer;
- men ≥ 50 years；
- tPSA level of 4-10 ng/ml, and fPSA/tPSA<0.16;
- tPSA level of >10 ng/ml；
- With abnomal mpMRI、PET/CT、TRUS or DRE;
Key exclusion criteria (6 listed)
- Not meet all of the inclusion criteria or any single inclusion criteria；
- previous diagnosis of prostate carcinoma ;
- symptomatic of acute prostatitis;
- local anesthetic allergy patients;
- cannot tolerate prostate biopsy or has contraindication to biopsy;
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 |
|---|---|---|
| prostate cancer diagnosisprostate cancer diagnosis | Other | Sample for Circulating Tumoral Cells |
Primary outcome
Positive predictive value of CTCs counts for prostate cancer
Time frame: 12 weeks
Evaluation the diagnostic ability of CTCs counts in caner and non-cancer. All patients were confirmed by pathology.
2 secondary outcomes
Correlation between CTCs counts and PIRADS score
Time frame: 12 weeks
combined PIRADS score for cancer and non-cancer
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
- Individual participant dataSharing planned: No
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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.
liang liang contact
yang gao study chair
First Affiliated Hospital Xi'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing prostate cancer diagnosis in people with Prostate Cancer, run by First Affiliated Hospital Xi'an Jiaotong University 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 6 inclusion and 6 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 5 Feb 2024. 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 yang gao (0086-029-85323473, gaoyangxjtu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive predictive value of CTCs counts for prostate cancer (time frame: 12 weeks). 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 5 Feb 2024.