Targeted and perilesional biopsy (TPLBx)Combined targeted and systematic biopsy (CTSBx)
Targeted and perilesional biopsy (TPLBx): The biopsy procedure is conducted by highly skilled and experienced urologists who specialize in performing prostate biopsies. A single dose of prophylactic antibiotics (usually cephalosporins) is routinely administered 30 min before the procedure. For each predefined MRI suspicious lesion, TBs are obtained within the ROI, followed by ring-distributed PB cores within a 10-15 mm radius around the ROI. The location of these cores depends on the shape and location of the suspicious lesion.
Combined targeted and systematic biopsy (CTSBx): The biopsy procedure is conducted by highly skilled and experienced urologists who specialize in performing prostate biopsies. A single dose of prophylactic antibiotics (usually cephalosporins) is routinely administered 30 min before the procedure. TBs are performed within each predefined MRI suspicious lesion, followed by SB.
Study summary
The goal of this randomized controlled trial (RCT) is to evaluate the efficacy of different prostate biopsy schemes in prostate cancer diagnosis among men with multiple MRI visible lesions, including combination of targeted and perilesional (PB) (TPLBx) and combination of systematic biopsy and targeted biopsy (CTSBx).
The main questions it aims to answer are:
Does TPLBx promote the accurate diagnosis of clinically significant prostate cancer (csPCa) among men with multiple MRI visible lesions? What's the value of TPLBx in improving the evaluation of prostate cancer when developing the treatment plan for patients with multiple MRI visible lesions? What's the value of TPLBx in avoiding the adverse pathological outcomes after the radical prostatectomy such as upgrade, upstage, and capsule invasion among patients with multiple MRI visible lesions? Researchers will compare the cancer detection rates of TPLBx and CTSBx to explore the efficacy of different prostate biopsy schemes.
Participants will:
Receive TPLBx or CTSBx.
Eligibility
Sex
MALE
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria:
* the age of the patient is between 18 and 85;
* no previous biopsy;
* presence of multiple MRI visible lesions;
* every MRI visible lesion is in accordance with the EAU guidelines for performing perilesional biopsy (PB) (PI-RADS ≥4 or PI-RADS =3, clinical suspicion of PCa);
* a verified prostate-specific antigen (PSA) less than 50 ng/ml;
* complete MRI data, and high MRI quality (Prostate Imaging Quality \[PI-QUAL\] V1.0 score ≥3);
* the time interval between prostate biopsy and prostate MRI examination should not exceed one month;
* patients with complete prostate biopsy pathological results;
* patients with complete clinical information.
Exclusion Criteria:
* contraindication for MRI examination (i.e., in acute attack period such as high fever, coma, epilepsy, prone to cardiac arrest, claustrophobia, presence of ferrous metallic implants, or claustrophobia);
* contraindication for prostate biopsy ((a) in the period of acute infection or fever; (b) hypertensive crisis; (c) in the decompensated stage of heart failure; (d) diseases with severe bleeding tendency; (e) poorly controlled complications of hypertension or diabetes; (f) patients with severe internal or external hemorrhoids, perianal or rectal lesions should not undergo transrectal biopsy);
* a history of radiotherapy, chemotherapy, androgen deprivation therapy, or surgery for PCa;
* patients with previous biopsy;
* the absence of MRI-visible prostate lesions or presence of single suspicious lesions;
* PI-RADS V2.1 \<3;
* unqualified or incomplete MRI data;
* the patient could not cooperate to complete the prostate biopsy;
* the patients or their family members refused to participate in this study;
* patients with incomplete clinical information.
Primary outcome measure(s)
The clinically significant prostate cancer (csPCa) detection rate for TPLBx and CTSBx schemes — One month after the biopsy procedure. The csPCa was defined as prostate cancer (PCa) with a grade group ≥2 or Gleason score (GS) ≥3+4. The reference standard was the pathological result.
Trial sites (1)
Facility
City
Region
Status
Peking University First Hospital
Beijing
Beijing Municipality
Recruiting
More Peking University First Hospital trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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