Evaluation of Perilesional Biopsy in Diagnosis of Prostate Cancer
ConditionProstate Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age45-85
SponsorPeking University First Hospital
About this trial
The goal of this multicenter randomized controlled trial (RCT) is to evaluate the efficacy of different prostate biopsy schemes, including perilesional biopsy (PB) and combination of systematic biopsy and targeted biopsy (TB+SB).
The main questions it aims to answer are:
Does PB promote the accurate diagnosis of clinically significant prostate cancer? What's the value of PB in improving the safety of prostate biopsy? Researchers will compare the cancer detection rates of PB and TB+SB to explore the efficacy of different prostate biopsy schemes.
Participants will:
Receive TB+PB or TB+SB.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The age of the patient is between 45 and 85.
No previous biopsy.
Patients with single suspicious lesion, complete MRI 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 MRI data was unqualified or incomplete.
Patients had received radiotherapy, chemotherapy, androgen deprivation therapy, or surgery treatment before prostate MRI examination or prostate biopsy.
Patients with previous biopsy.
Patients with PI-RADS V2.1 of < 4.
Trial design
Design model
Parallel
Treatments tested in this trial
TB+PB
Procedure/SurgeryThe biopsy procedure was conducted by highly skilled and experienced urologists who specializes in performing prostate biopsies. Prophylactic antibiotics were routinely used both before and one day prior to scheduled surgery. For each predefined MRI suspicious lesion, TB cores were obtained within each predefined MRI suspicious lesion (region of interest, ROI), followed by ring-distributed PB cores within a 10-15 mm radius around the ROI. The location of these cores depended on the shape and location of the suspicious lesion.
TB+SB
Procedure/SurgeryThe biopsy procedure was conducted by highly skilled and experienced urologists who specializes in performing prostate biopsies. Prophylactic antibiotics were routinely used both before and one day prior to scheduled surgery. TB cores were obtained from the lesion, followed by 12-core SB.
Treatment groups
640 Participants
are divided into 2 treatment groupsGroup A: TB+PB groupExperimental treatment 1 intervention
Group B: TB+SB groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The clinically significant prostate cancer (csPCa) detection rate for TB+PB and TB+SB
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+SB.
Time frame
One month after the biopsy procedure.2
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.3
The clinically insignificant PCa (ciPCa) detection rate
The ciPCa was defined as PCa with a grade group \<2 or GS \<3+4. 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 (GS) 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. The minimum and maximum of GS are 3 and 5. The higher GS means the higher pathological grade.
Time frame
One month after the biopsy procedure.Other outcomes
1
The self-reported quality of life after the prostate biopsy
The self-reported levels of pain and discomfort after the prostate biopsy was measured through visual analogue scale (VAS). The minimum and maximum values of VAS are 0 and 10. The higher VAS means the higher level of pain and discomfort.
Time frame
One month after the biopsy procedure.2
The Gleason score (GS) of radical prostatectomy (RP) specimens
For the RP specimens, the Gleason score (GS) 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. The minimum and maximum of GS are 3 and 5. The higher GS means the higher pathological grade.
Time frame
One month after the biopsy procedure.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Peking University First Hospital
Lead sponsor
Beijing Hospital
Collaborator
Shanghai East Hospital
Collaborator
Beijing Friendship Hospital
Collaborator
Chinese People's Liberation Army (PLA) General Hospital
Collaborator
Zhejiang Cancer Hospital
Collaborator
First Affiliated Hospital of Chongqing Medical University
Collaborator
Tianjin Medical University Cancer Institute and Hospital
Collaborator
Source ClinicalTrials.gov