Comparison of TB+PB and TB+6SB for Prostate Cancer Diagnosis
ConditionProstate Cancer (Diagnosis)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-85
SponsorPeking University First Hospital
About this trial
The goal of this randomized controlled trial (RCT) is to evaluate the diagnostic efficacy of two novel prostate biopsy schemes, including targeted and perilesional biopsy (TB+PB) and combination of sextant-systematic biopsy and targeted biopsy (TB+6SB).
The main questions it aims to answer are:
Does TB+PB promote the accurate diagnosis of clinically significant prostate cancer (csPCa)? Could TB+6SB achieve the non-inferior diagnostic efficacy compared to TB+PB scheme? What's the value of TB+6SB in improving the detection of prostate cancer in the negative prostate lobe (contralateral to the index lesion)? In the era of MRI-targeted biopsy (TB), when TB and PB is effectively conducted and allows confident detection of the ROI, do we still need to perform SB? Researchers will compare the cancer detection rates of TB+PB and TB+SB to explore the efficacy of different prostate biopsy schemes. They will evaluate the diagnostic profile of different prostate biopsy schemes through the spatial analysis of the prostate.
Participants will:
Receive TB+PB or TB+6SB.
Eligibility criteria
Qualifiers
The age of the patient is between 18 and 85.
No previous biopsy.
Patients with single suspicious lesion, complete multiparametric magnetic resonance imaging (mpMRI) data, qualified image quality control, suspicious lesions, and Prostate Imaging Reporting and Data System version 2.1 (PI-RADS V2.1) of ≥ 3.
Patients were in accordance with the indication of prostate biopsy, including patients with suspicious prostate nodes found by digital rectal examination (DRE), the suspicious lesions found by transrectal ultrasound (TRUS) or MRI, total prostate-specific antigen (tPSA) >10ng/mL, tPSA 4-10ng/mL with free-to-total PSA ratio (f/tPSA) <0.16 or PSA density (PSAD) >0.15.
Disqualifiers
The mpMRI data was unqualified or incomplete.
Patients had received radiotherapy, chemotherapy, androgen deprivation therapy, or surgery treatment before prostate mpMRI examination or prostate biopsy.
Patients with previous biopsy.
Patients with PI-RADS V2.1 of < 3.
Trial design
Treatments tested in this trial
- TB+PB
- TB+6SB
Treatment groups
592 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov