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A prospective, muticenter, randomized clinical trial of transrectal prostate biopsy guided by the prostate biopsy system

A prospective, muticenter, randomized clinical trial of transrectal prostate biopsy guided by the prostate biopsy system

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000030061
Enrollment
Unknown
Registered
2020-02-22
Start date
2020-11-26
Completion date
Unknown
Last updated
2021-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

prostate cancer

Interventions

experimental group:MRI-TRUS software fusion was used to conduct perineal prostate puncture guided by experimental instruments
control group:MRI-TRUS cognitive fusion, ultrasound-guided transrectal puncture

Sponsors

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
No minimum to 80 Years

Inclusion criteria

Inclusion criteria: 1. Male, younger than 80 years old; 2. Meet any of the following criteria: 1) rectal examination (DRE) to find suspicious nodules of the prostate, any PSA value; 2) PSA>=10ug/L; 3) PSA 4ug/L to 10ug/L; f/t PSA= 2 points; 4. Prostate length <= 64mm; 5. Compliance is good and can communicate well with researchers; 6. Voluntarily participate in the study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1) Patients with prostate cancer or acute prostatitis have been diagnosed; 2) In the acute infection period, or, urinary tract infection,investigator believe that abnormal urine routine has clinical significance ; 3)Prostate puncture within 1 month; 4) Being in a decompensated period of cardiac insufficiency; 5) Those who have a serious bleeding tendency, or those who take anticoagulants for a long time can not stop the drug; 6) have severe internal hemorrhoids, external hemorrhoids, perianal or rectal lesions; 7) Patients with severe bone and joint disease cannot be placed in the left lateral position or the lithotomy position; 8) Have a high blood pressure crisis; 9) unable to perform anesthesia; 10) Those who have mental illness or mental disorders who do not understand the informed consent form; 11) Other surgical contraindications, or those considered by the investigator to be unsuitable for participation in the trial.

Design outcomes

Primary

MeasureTime frame
Positive detection rate;

Secondary

MeasureTime frame
Targeted puncture positive detection rate;Gleason>=7 detection rate;biospy time;blood;Postoperative FRS score;Ultrasonic image quality evaluation;Concordant rate of targeted puncture and MRI report;Device function evaluation;

Countries

China

Contacts

Public ContactJian Huang

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

hjgcp2017@163.com+86 13600054833

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026