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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
TB+PB
Procedure/SurgeryThe biopsy procedure was conducted by a highly skilled and experienced urologist who specializes in performing prostate biopsies. Prophylactic antibiotics were routinely used both before and one day prior to scheduled surgery. Each patient was placed in the left lateral position or lithotomy position. The ultrasound equipment used included a color Doppler ultrasound diagnostic instrument (Hitachi HiVision, Philips Epiq 7), transrectal probes, and corresponding puncture needle guns. Color Doppler examination was performed from the base to the apex. For patients in the TB+PB group, three-core TB was obtained within the predefined MRI suspicious lesion (ROI), followed by ring-distributed 6-core PB within a 10 to 15 mm radius around the ROI. The location of these nine cores depended on the shape and location of the suspicious lesion. Each core was placed in an individual container and reported separately in accordance with the Ginsburg scheme.
TB+6SB
Procedure/SurgeryThe biopsy procedure was conducted by a highly skilled and experienced urologist who specializes in performing prostate biopsies. Prophylactic antibiotics were routinely used both before and one day prior to scheduled surgery. Each patient was placed in the left lateral position or lithotomy position. The ultrasound equipment used included a color Doppler ultrasound diagnostic instrument (Hitachi HiVision, Philips Epiq 7), transrectal probes, and corresponding puncture needle guns. Color Doppler examination was performed from the base to the apex. For patients in the TB+6SB group, three-core TB within the predefined mpMRI index lesion (ROI) was firstly performed. Then patients received six-core sextant-SB bilaterally with each side two cores in the peripheral zone and one core in the transitional zone. Each core was placed in an individual container and reported separately in accordance with the Ginsburg scheme.
Treatment groups
592 Participants
are divided into 2 treatment groupsGroup A: TB+PB groupExperimental treatment 1 intervention
Group B: TB+6SB groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The clinically significant prostate cancer (csPCa) detection rate for TB+PB and TB+6SB.
csPCa was defined as PCa with a grade group ≥ 2 or GS ≥ 7. The reference standard was the pathological result.
Time frame
One month after the biopsy procedure.Secondary outcomes
1
The PCa detection rate
The PCa detection rate for TB+PB and TB+6SB.
Time frame
One month after the biopsy procedure.2
The clinically insignificant PCa (ciPCa) detection rate
The clinically insignificant PCa (ciPCa) was defined as PCa with a grade group \< 2 or GS \< 7. The reference standard was the pathological result.
Time frame
One month after the biopsy procedure.3
The high-grade PCa detection rate
The high-grade PCa was defined as PCa with a grade group ≥ 3 or GS ≥ 4+3. The reference standard was the pathological result.
Time frame
One month after the biopsy procedure.4
The Gleason score (GS) of the biopsy sample
The Gleason score was reported by senior uropathologists according to the Standards of Reporting for MRI Targeted Biopsy Studies (START) criteria and interpreted according to the recommendations of the International Society of Urological Pathology (ISUP) Grade Group.
Time frame
One month after the biopsy procedure.Sponsors and contacts
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Source ClinicalTrials.gov