Non-inferiority Randomized Controlled Trial of Cognitive Targeted Biopsy Versus Software Targeted Biopsy

Launched by SHANGHAI EAST HOSPITAL · Feb 13, 2020

Keywords

ClinConnect Summary

**Clinical Trial Summary: Targeting Prostate Cancer Detection**

This clinical trial is comparing two methods of detecting significant prostate cancer in men who might have the disease. One method uses a cognitive approach, where doctors use their experience and knowledge to guide biopsies, while the other relies on software that helps pinpoint where to take samples. The goal is to see if both methods are equally effective in finding clinically significant cancer, which means cancer that could impact a man's health.

Men aged 18 and older who have a prostate-specific antigen (PSA) level between 4 to 20 ng/ml or an abnormal digital rectal exam (DRE) may be eligible to participate. Participants will need to sign an informed consent form, which means they agree to take part in the trial after being fully informed about it. Those with certain conditions, like prostatitis (inflammation of the prostate) or who cannot undergo a biopsy or MRI, won't be able to join. If you decide to participate, you’ll help researchers understand which biopsy approach is better, potentially improving prostate cancer detection for others in the future.

Gender

MALE

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