Non-inferiority Randomized Controlled Trial of Cognitive Targeted Biopsy Versus Software Targeted Biopsy
Recruiting · NCT04271527 · Interventional (participants receive a specific treatment) · Lead sponsor: Shanghai East Hospital
View the official record on ClinicalTrials.gov →Interventions studied
cognitive fusion targeted biopsy
What this trial is about
This is a randomized controlled and non-inferiority trial in comparison of the cognitive fusion targeted biopsy between the software-based fusion targeted biopsy in the detection rate of clinically significant cancer in men suspected to have a PCa.
Who can take part
Age range
18 Years and older
Sex
Male
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Age \> 18
- PSA increase to 4-20 ng/ml and/or abnormal DRE;
- Sign the informed consent
Exclusion criteria
- Have acute or chronic prostatitis
- Contraindications to prostate biopsy
- Contraindications to MRI
- Other reasons that not suitable for this trial
Where it is running
1 location listed.
- Shanghai East Hospital, Tongji University School of Medicine - Shanghai, Shanghai Municipality, China