Prostate NeoplasmNCT04376008

A Prospective Study Of Free-Hand Transperineal Image Fusion Targeted Biopsies Under Local Anesthesia

A study testing Standard prostate biopsy and Targeted and standard prostate biopsy in people with Prostate Neoplasm, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This trial aims to prospectively assess the feasibility, complications and functional results of free-hand transperineal image fusion targeted biopsies under local anesthesia in a large group of patients. Read more about this study

Who is it for?: Ages 18 to 80 years, men only
Conditions the study is for: Prostate Neoplasm
What is being tested?: Standard prostate biopsy and Targeted and standard prostate biopsy
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,050 participants
Where: 1 siteChina
Study dates: 1 May 2018to 1 Jun 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;
Suspected stage ≤ T2 on rectal examination (organ-confined prostate cancer) 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;
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, estimated glomerular filtration rate ≤ 50mls/min);
Contraindication to prostate biopsy.

Trial locations and contacts

1 site in 1 country.

China1 site

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210000

Other trials in China

About this study

Official title: Evaluation of Feasibility, Complications And Functional Results Of Free-Hand Transperineal Image Fusion Targeted Biopsies Under Local Anesthesia: A Prospective Study

Read the detailed description

12-core transrectal ultrasound (TRUS) biopsy is one of the most performed urological procedures and remains the standard method for prostate cancer (PCa) histological diagnosis according to the most recent Guidelines. During the last decade, the transperineal prostate biopsy has attracted renewed interest. However, only a few studies and no large prospective studies investigated complications of the transperineal approaches.

Image fusion of Multi-parameter MRI (mpMRI) and TRUS guided prostate targeted biopsy had equivalent results with standard 12-core biopsy. Combination of targeted and standard biopsy was recommended in recent Guidelines. Image fusion targeted biopsy needs satisfactory anesthetic effect, and no prospective studies investigated feasibility in this approach under local anesthesia.

The scientific urological community is focusing on detection rate and concordance with final pathology of the radical prostatectomy specimen, which remain the cornerstones to assess the accuracy of a prostate biopsy technique. In this study, the investigators will additionally assess the functional results of erectile function and urinary function.

Together, the investigators will perform free-hand image fusion targeted biopsies plus standard biopsies under local anesthesia in patients recruited in this study. Then, Feasibility, such as peri-procedural pain, changes in patients quality of life; complications, such as infection rate and bleeding rate; functional results, such as erectile function and urinary function; and concordance with final pathology will be evaluated.

Conditions: Prostate Neoplasm
Being tested: Standard prostate biopsy, Targeted and standard prostate 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.

Standard prostate biopsyProcedure or surgery
Transperineal TRUS guided standard prostate biopsy (SB).
Targeted and standard prostate biopsyProcedure or surgery
Transperineal Image fusion-guided targeted and standard prostate biopsy (TB+SB).

Study groups in NCT04376008
Study group	Role	What they receive
PI-RADS 1-2	Experimental	Standard prostate biopsy Receives: Procedure: Standard prostate biopsy
PI-RADS 3-5	Experimental	Targeted and standard prostate biopsy Receives: Procedure: Targeted and standard prostate biopsy

What is being measured

The primary outcome is the main question the study is designed to answer.

Biopsy unfinished rates
The proportion of patients who failed to complete the biopsy due to various reasons during the biopsy
Measured: 1 days
Pain score
Numerical pain scale score during biopsy, the minimum to maximum value is 0 to 10, and higher scores mean a worse outcome
Measured: 3 days peri-biopsy
Hospitalization rate due to biopsy
The proportion of subjects requiring hospitalization for various reasons within 7 days after puncture
Measured: 7 days post biopsy

Secondary outcomes (7)

Detection rates of clinically significant PCa
Clinically significant prostate cancer is considered as: biopsy Gleason score ≥3+4 or maximum cancer core length ≥5 mm.
Measured: 30 days post biopsy
Detection rates of PCa
Prostate cancer is considered as: biopsy Gleason score ≥3+3
Measured: 30 days post biopsy
Biopsy-related complication rates
Measured: 30 days post biopsy
Biopsy time
How much time is used during biopsy
Measured: 1 days
Consistency rate with final pathology
Concordance rate between biopsy and final pathology
Measured: 30 days post biopsy
international index of erectile function-5 (IIEF-5) score
pre- and post-procedural erectile function score, the minimum to maximum value is 0 to 25, and higher scores mean a better outcome
Measured: 30 days post biopsy
International prostate symptom score (IPSS)
pre- and post-procedural urinary function score, the minimum to maximum value is 0 to 35, and higher scores mean a worse outcome
Measured: 30 days post biopsy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 20181 Jun 2022

First posted6 May 2020
Study start1 May 2018
Primary completion1 May 2021
Study completion1 Jun 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Prostate NeoplasmStudies 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 1,050 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04376008
Sponsor's protocol ID: IUNU-PC-104
Status last verified: Oct 2022
First submitted: 1 May 2020
Last updated: 24 Oct 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Prostate Neoplasm trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Feasibility, Complications And Functional Results Of Free-Hand Transperineal Image Fusion Targeted Biopsies Under Local Anesthesia: A Prospective Study
ClinicalTrials.gov ID: NCT04376008
Acronym / sponsor ID: IUNU-PC-104
Conditions: Prostate Neoplasm
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,050 participants (actual)
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
Study start: 1 May 2018 (actual)
Primary completion: 1 May 2021 (actual)
Study completion: 1 Jun 2022 (actual)
First posted: 6 May 2020 (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.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
PI-RADS 1-2	Experimental	Procedure: Standard prostate biopsyStandard prostate biopsy
PI-RADS 3-5	Experimental	Procedure: Targeted and standard prostate biopsyTargeted and standard prostate 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;
Suspected stage ≤ T2 on rectal examination (organ-confined prostate cancer) 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;
Able to provide written informed consent.

Key exclusion criteria (4 listed)

Prior prostate biopsy or prostate surgery;
Prior treatment for prostate cancer;
Contraindication to MRI (e.g. claustrophobia, pacemaker, estimated glomerular filtration rate ≤ 50mls/min);
Contraindication to prostate 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
Standard prostate biopsyTransperineal TRUS guided standard prostate biopsy (SB).	Procedure or surgery	PI-RADS 1-2
Targeted and standard prostate biopsyTransperineal Image fusion-guided targeted and standard prostate biopsy (TB+SB).	Procedure or surgery	PI-RADS 3-5

Primary outcome

Biopsy unfinished rates
Time frame: 1 days
The proportion of patients who failed to complete the biopsy due to various reasons during the biopsy
Pain score
Time frame: 3 days peri-biopsy
Numerical pain scale score during biopsy, the minimum to maximum value is 0 to 10, and higher scores mean a worse outcome
Hospitalization rate due to biopsy
Time frame: 7 days post biopsy
The proportion of subjects requiring hospitalization for various reasons within 7 days after puncture

7 secondary outcomes

Detection rates of clinically significant PCa
Time frame: 30 days post biopsy
Detection rates of PCa
Time frame: 30 days post biopsy
Biopsy-related complication rates
Time frame: 30 days post biopsy
Biopsy time
Time frame: 1 days
Consistency rate with final pathology
Time frame: 30 days post biopsy
international index of erectile function-5 (IIEF-5) score
Time frame: 30 days post biopsy
International prostate symptom score (IPSS)
Time frame: 30 days post biopsy

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2022.

Related trials for Prostate Neoplasm

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 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: finished, as of the sponsor's last update on 24 Oct 2022. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Biopsy unfinished rates (time frame: 1 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04376008.

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 24 Oct 2022.