Non-inferiority Randomized Controlled Trial of Cognitive Targeted Biopsy Versus Software Targeted Biopsy
Recruiting
N/A
Interventional Study
Prostate Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 18 and older
- Sex
- Male
- Study type
- Interventional
- Purpose
- Diagnostic
- Participants needed
- 626 (estimated)
- Sponsor
- Shanghai East Hospital · Other
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About This Trial
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Age \> 18
2. PSA increase to 4-20 ng/ml and/or abnormal DRE;
3. Sign the informed consent
Exclusion Criteria:
1. Have acute or chronic prostatitis
2. Contraindications to prostate biopsy
3. Contraindications to MRI
4. Other reasons that not suitable for this trial
Contacts