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Which biopsy method to choose when men have abnormal PSA and/or DRE, a randomized study comparing current practice with innovative practice

A randomized controlled trial to assess and compare the outcomes of AI-US-CT-guided biopsy, transrectal ultrasound-guided 12-core systematic biopsy, and mpMRI-assisted 12-core systematic biopsy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN18033113
Enrollment
360
Registered
2016-12-28
Start date
2016-02-22
Completion date
Unknown
Last updated
2022-08-22

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

Conditions

Prostate cancer Cancer Prostate cancer

Interventions

Patients are randomly assigned in a 1:1:1 ratio to one of three groups using a computer-generated list of random numbers. Patients are allocated by an independent third party to ensure that the random

Sponsors

Science Technology Department of Zhejiang Province
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. Male 2. Under 85 years of age 3. Verified prostate-specific antigen (PSA) > 4 ng/ml and/or abnormal DRE 4. Provision of signed informed consent

Exclusion criteria

Exclusion criteria: 1. No signed informed consent 2. Patients who have been included in published cohorts

Design outcomes

Primary

MeasureTime frame
Prostate cancer detection rate is assessed through medical record review 1 week post-test.

Secondary

MeasureTime frame
1. The positive rate for biopsy cores is assessed through medical record review 1 week post-test 2. The number of biopsy cores needed to detect one prostate cancer is acquired through medical record review 1 week post-test 3. In mpMRI group, the prostate cancer detection rate for each PI-RADS category is acquired through medical record review 1 week post-test

Countries

China

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 14, 2026