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Prostate CancerNCT06841211

Optimizing Prostate Biopsy Schemes in Men With Multiple MRI Visible Lesions

A study testing Targeted and perilesional biopsy (TPLBx) and Combined targeted and systematic biopsy (CTSBx) in people with Prostate Cancer, run by Peking University First Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 85 years, men only
Conditions the study is for
Prostate Cancer
What is being tested?
Targeted and perilesional biopsy (TPLBx) and Combined targeted and systematic biopsy (CTSBx)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
572 participants
Where
1 siteChina
Study dates
1 Feb 2025to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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);
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  • 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting
  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

    Baowei Zhang, +86 83572466, bdyyll@126.com

    Recruiting

Other trials in China

About this study

Official title: 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

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:

Read more

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.

Read the detailed description

Prostate biopsies have been the cornerstone of prostate cancer (PCa) diagnosis, risk stratification, and treatment planning. The optimal biopsy scheme should achieve the highest csPCa detection rates with the most accurate core sites and the least biopsy-cores. The combined targeted and systematic biopsy (CTSBx) could effectively detect clinically significant PCa (csPCa) and was the standard scheme for patients with visible suspicious lesions on MRI in the past. However, some limitations existed in the CTSBx scheme, including the detection of clinically insignificant PCa (ciPCa), the risk of post-biopsy complications, and adverse pathological changes such as upgrade, upstage, capsule invasion, and positive surgical margin after the radical prostatectomy (RP). Therefore, more and more radiologists and urologists focused on the issue of optimization of prostate biopsy schemes. Recent studies demonstrated that the majority of csPCa were found within a band of 10-mm radius outside MRI lesions (the penumbra). Focusing biopsy cores within and around the region of interest (ROI), known as targeted and perilesional biopsy (TPLBx) scheme, is recommended by the latest EAU guideline for the diagnosis of patients with visible suspicious lesions on MRI.

Prostate cancer generally occurs multifocally. The incidence of multiple lesions among different cohorts in previous studies ranges between 20% and 50%. Though the CTSBx schemes are usually utilized for these patients, some previous studies suggested that additional systematic biopsy is of limited informative value in terms of overall csPCa detection. Therefore, the optimal prostate biopsy scheme for patients with multiple visible MRI suspicious lesions is still a matter of debate. Compared with the CTSBx scheme, the TPLBx changed the distribution of the biopsy-core according to the location of visible suspicious lesions. Many studies have preliminarily verified that the diagnostic efficacy of TPLBx was not inferior to that of CTSBx with the benefits of decreasing the detection of ciPCa and reducing biopsy cores. TPLBx scheme focuses biopsy cores within and around the ROI, which may evaluate the pathological characteristics of MRI visible suspicious lesions more accurately, benefiting for the treatment planning and reducing the occurrence rates of adverse pathological changes after the radical prostatectomy (RP). However, current data for TPLBx schemes are mostly retrospective, and few studies focused on the application of TPLBx for patients with multiple MRI visible lesions. Thus, this randomized controlled trial (RCT) aims to evaluate the efficacy of TPLBx and CTSBx schemes for patients with multiple MRI visible lesions, provide high-quality evidence for the optimization of prostate biopsy schemes.

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
Prostate Cancer
Being tested
Targeted and perilesional biopsy (TPLBx), Combined targeted and systematic biopsy (CTSBx)
Keywords
Prostate cancer, Randomized controlled trial, Targeted biopsy, Perilesional biopsy, Diagnosis
Medical subject headings
Prostatic Neoplasms, Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Targeted and perilesional biopsy (TPLBx)Procedure or surgery

    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)Procedure or surgery

    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 groups in NCT06841211
Study groupRoleWhat they receive
Targeted and perilesional biopsy (TPLBx)ExperimentalFor 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.
Receives: Procedure: Targeted and perilesional biopsy (TPLBx)
Combined targeted and systematic biopsy (CTSBx)ExperimentalFor patients in the CTSBx group, TBs were performed within each ROI, followed by a sextant systematic biopsy (SB).
Receives: Procedure: Combined targeted and systematic biopsy (CTSBx)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The clinically significant prostate cancer (csPCa) detection rate for TPLBx and CTSBx schemes

    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.

    Measured: One month after the biopsy procedure.

Secondary outcomes (6)
  1. The PCa detection rate

    The PCa detection rate for TPLBx and CTSBx schemes.

    Measured: One month after the biopsy procedure.

  2. 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.

    Measured: One month after the biopsy procedure.

  3. The high-grade PCa detection rate for TPLBx and CTSBx schemes

    The high-grade PCa was defined as PCa with a grade group ≥3 or GS≥4+3. The reference standard was the pathological result.

    Measured: 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.

    Measured: One month after the biopsy procedure.

  5. The GS of radical prostatectomy (RP) specimens

    The overall grade was assigned based on the part with the highest Gleason score according to the recommendations of the ISUP. For the RP specimens, the overall grade was assigned based on the part with the highest Gleason score according to the recommendations of the ISUP.

    Measured: One month after the RP.

  6. The adverse pathological outcomes of radical prostatectomy (RP) specimens

    The adverse pathological outcomes such as upgrading, upstaging, and capsule invasion were assessed and reported by the senior uropathologists based on RP specimens.

    Measured: One month after the RP.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2025
  2. Study start1 Feb 2025
  3. Primary completion31 Aug 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
572 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06841211
Sponsor's protocol ID
PB-03
Status last verified
Jun 2026
First submitted
18 Feb 2025
Last updated
11 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Targeted and perilesional biopsy (TPLBx) and Combined targeted and systematic biopsy (CTSBx) in people with Prostate Cancer, run by Peking University First Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yi LIU (+86 13611035261, liuyipkuhsc@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The clinically significant prostate cancer (csPCa) detection rate for TPLBx and CTSBx schemes (time frame: One month after the biopsy procedure.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.

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