Clinical trial · Interventional
Optimizing Prostate Biopsy Schemes in Men With Multiple MRI Visible Lesions
Optimizing Prostate Biopsy Schemes in Men With Multiple MRI Visible Lesions: a Randomized Controlled Trial Evaluating the Efficacy of Perilesional Biopsy in Prostate Cancer Diagnosis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Combined targeted and systematic biopsy (CTSBx) | Procedure | — | UNRESOLVED |
| Targeted and perilesional biopsy (TPLBx) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Targeted and perilesional biopsy (TPLBx)
- description
- For patients in the TPLBx group, targeted biopsies (TBs) were obtained within each predefined MRI suspicious lesion (region of interest, ROI), followed by ring-distributed perilesional biopsy (PB) cores within a 10-15 mm radius around the ROI. The location of these cores depended on the shape and location of the ROI.
- interventionNames
- Procedure: Targeted and perilesional biopsy (TPLBx)
- type
- EXPERIMENTAL
- label
- Combined targeted and systematic biopsy (CTSBx)
- description
- For patients in the CTSBx group, TBs were performed within each ROI, followed by a sextant systematic biopsy (SB).
- interventionNames
- Procedure: Combined targeted and systematic biopsy (CTSBx)
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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.
References
Publications (0)
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