Prostate CancerNCT04983706
Optimization of the Core Number and Location for Targeted Prostate Biopsy
A study testing MRI/Ultrasound Fusion Saturation Biopsy in people with Prostate Cancer, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial summary
This study aims to investigate the effect of core number and location optimization for targeted prostate biopsy on pathological accuracy. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- MRI/Ultrasound Fusion Saturation Biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 5 Jul 2021to May 2022
- 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 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men more than 18 years old with clinical suspicion of prostate cancer;
- Serum PSA ≤ 20 ng/ml within the previous 3 months;
- No evidence of PSA increase by noncancerous factors, such as catheterization, bladder stones, or urinary tract infection including bacterial prostatitis;
- mpMRI PI-RADS V2.1 score ≥4, diameter of ≤2.5 cm；
- Able to provide written informed consent.
Who cannot join
- Prior prostate biopsy or prostate surgery;
- Prior treatment for prostate cancer;
- Contraindication to MRI (e.g. claustrophobia, pacemaker);
- Contraindication to prostate biopsy;
- Men in whom artifact would reduce the quality of the MRI.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210000
Hongqian Guo, MD, 8613605171690, dr.ghq@nju.edu.cn
Qun Lu, MD, 8615195856020, luqun_1989@126.com
About this study
Official title: An Exploratory Study of Optimizing the Core Number and Location for MRI/Ultrasound Fusion Targeted Prostate Biopsy
This study aims to investigate the effect of core number and location optimization for targeted prostate biopsy on pathological accuracy.
Read the detailed description
This is a single-center prospective study. The investigators perform MRI/US image fusion targeted saturation biopsy on prostate lesions with PI-RADS score 4, to investigate the effect of core number and location optimization for targeted prostate biopsy on pathological accuracy.
- Conditions
- Prostate Cancer
- Being tested
- MRI/Ultrasound Fusion Saturation Biopsy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI/Ultrasound Fusion Saturation BiopsyProcedure or surgery
MRI/Ultrasound fusion saturation biopsy: the core number and location are designed according to the lession condition.
| Study group | Role | What they receive |
|---|---|---|
| MRI/Ultrasound Fusion Saturation Biopsy | Experimental | Not described Receives: Procedure: MRI/Ultrasound Fusion Saturation Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The significant prostate cancer detection rate with different combinations of core number and location in the targeted saturated biopsy area
Measured: When histology results available, at an expected average of 3 days post-biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2021
- Study start5 Jul 2021
- Primary completionNov 2021 (estimated)
- Study completionMay 2022 (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 The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe 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
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongqian Guo, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04983706
- Sponsor's protocol ID
- IUNU-PC-110
- Status last verified
- Jul 2021
- First submitted
- 1 Jul 2021
- Last updated
- 30 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of Optimizing the Core Number and Location for MRI/Ultrasound Fusion Targeted Prostate Biopsy
- ClinicalTrials.gov ID
- NCT04983706
- Acronym / sponsor ID
- IUNU-PC-110
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 5 Jul 2021 (actual)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 30 Jul 2021 (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 study aims to investigate the effect of core number and location optimization for targeted prostate biopsy on pathological accuracy.
Detailed description
This is a single-center prospective study. The investigators perform MRI/US image fusion targeted saturation biopsy on prostate lesions with PI-RADS score 4, to investigate the effect of core number and location optimization for targeted prostate biopsy on pathological accuracy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI/Ultrasound Fusion Saturation Biopsy | Experimental | Procedure: MRI/Ultrasound Fusion Saturation Biopsy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men more than 18 years old with clinical suspicion of prostate cancer;
- Serum PSA ≤ 20 ng/ml within the previous 3 months;
- No evidence of PSA increase by noncancerous factors, such as catheterization, bladder stones, or urinary tract infection including bacterial prostatitis;
- mpMRI PI-RADS V2.1 score ≥4, diameter of ≤2.5 cm；
- Able to provide written informed consent.
Key exclusion criteria (5 listed)
- Prior prostate biopsy or prostate surgery;
- Prior treatment for prostate cancer;
- Contraindication to MRI (e.g. claustrophobia, pacemaker);
- Contraindication to prostate biopsy;
- Men in whom artifact would reduce the quality of the MRI.
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 |
|---|---|---|
| MRI/Ultrasound Fusion Saturation BiopsyMRI/Ultrasound fusion saturation biopsy: the core number and location are designed according to the lession condition. | Procedure or surgery | MRI/Ultrasound Fusion Saturation Biopsy |
Primary outcome
The significant prostate cancer detection rate with different combinations of core number and location in the targeted saturated biopsy area
Time frame: When histology results available, at an expected average of 3 days post-biopsy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI/Ultrasound Fusion Saturation Biopsy in people with Prostate Cancer, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School 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 30 Jul 2021. 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 Hongqian Guo (8613605171690, dr.ghq@nju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The significant prostate cancer detection rate with different combinations of core number and location in the targeted saturated biopsy area (time frame: When histology results available, at an expected average of 3 days post-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 30 Jul 2021.