Editor's Note: Prostate biopsy has long been regarded as the “gold standard” for diagnosing prostate cancer. Yet as MRI-guided biopsy has become increasingly routine, clinical decision-making has become more complex:- Should biparametric MRI or multiparametric MRI be used?
- How many targeted biopsy cores are sufficient?
- Which approach is preferable—transperineal or transrectal?
- Should the biopsy strategy differ depending on whether the results will guide surgery, radiotherapy, or focal therapy?
These long-standing clinical questions have now received an international expert consensus.
The ProBIOPSY International Consensus, recently published in European Urology, was developed by 34 leading experts from urology, radiology, radiation oncology, pathology, nuclear medicine, and other disciplines through three rounds of Delphi consultation. It establishes a systematic and clinically actionable standardized framework for prostate biopsy in the MRI era.
I. Background and Methodology of the Consensus
Prostate biopsy has entered an era of MRI-guided precision diagnosis, but clinical implementation remains complex. Considerable variation persists in MRI sequence selection, the number of targeted biopsy cores, biopsy approach, and the extent of sampling required for different treatment scenarios.
Whether a single biopsy strategy can simultaneously meet the decision-making requirements of surgery, radiotherapy, focal ablation, and other treatment approaches has remained an unresolved question.
To address these issues, the ProBIOPSY consensus group adopted an internationally recognized modified Delphi methodology. A multidisciplinary panel of 34 leading experts from urology, radiology, radiation oncology, pathology, nuclear medicine, and other specialties participated in the process.
The experts evaluated 96, 99, and 112 statements across three successive rounds. These statements were ultimately organized into 36 core thematic areas. After each round of voting, the statements were revised and refined based on expert feedback.
The consensus statements were then subject to a final determination using a modified RAND appropriateness assessment methodology.
This process ensured that the recommendations were grounded in the best available evidence while incorporating the practical experience of leading international experts, providing a scientifically rigorous yet clinically actionable framework for standardizing prostate biopsy in the MRI era.
II. Key Consensus Recommendations
Core Domain 1: Selection of MRI and Novel Imaging-Based Diagnostic Pathways
1. Biparametric MRI vs Multiparametric MRI
The consensus strongly recommends formally assessing MRI quality according to the Prostate Imaging Quality (PI-QUAL) Version 2 criteria.
When image quality is sufficient to support clinical decision-making, both multiparametric MRI (mpMRI) and biparametric MRI (bpMRI) can be recommended for MRI-guided prostate cancer diagnosis.
When MRI acquisition follows the recommended PI-RADS imaging protocol, bpMRI alone can provide sufficient information for prostate cancer diagnosis and can be used for both opportunistic screening and organized screening.
For both mpMRI and bpMRI, 1.5-T and 3-T MRI scanners are considered suitable for prostate cancer diagnosis, with no minimum magnetic-field strength specified.
ProBIOPSY International Consensus: Key Recommendations for MRI-Guided Prostate Biopsy
Core Domain 1: MRI and Advanced Imaging Pathways
(2) Additional assessment of indeterminate lesions
In the bpMRI setting: Contrast-enhanced sequences may be added for indeterminate lesions in the peripheral zone. PSA density (PSAD) was the only biomarker supported by consensus for further risk assessment. Active surveillance with clinical and imaging follow-up was also considered an acceptable strategy for selected indeterminate lesions.
In the mpMRI setting: PSAD or validated risk calculators may be used to help determine whether biopsy is indicated. Serum and urine biomarkers, however, did not receive consensus support.
(3) Role of novel imaging technologies
PSMA PET/CT and micro-ultrasound (micro-US) should not replace MRI for the initial diagnosis of prostate cancer.
For patients with a negative MRI but a high clinical suspicion of clinically significant prostate cancer (csPCa), PSMA PET/CT may be considered as an adjunctive examination.
When MRI is negative but clinical suspicion of csPCa remains high, systematic biopsy (SBx) should be performed using a 12-core template, with six cores obtained from each side of the prostate.
AI-based algorithms may also be used as radiological decision-support tools to assist in the pre-identification of suspicious lesions on MRI.
Core Domain 2: Biopsy Strategy
(1) Number of targeted biopsy cores
There is currently no consensus on whether the optimal number of targeted biopsy (TBx) cores should be adjusted according to PI-RADS or Likert scores.
There was also no unanimous agreement regarding the minimum number of cores for MRI-visible lesions or PI-RADS 4–5 lesions. However, 66% and 68% of experts, respectively, favored obtaining at least three targeted cores.
(2) Perilesional biopsy
The expert panel reached consensus on the use of the term perilesional biopsy (PLBx) to describe additional cores obtained around the region of interest (ROI).
PLBx cores should be obtained within 10 mm of the ROI.
The number of PLBx cores should be adjusted according to lesion size. For lesions ≥10 mm in diameter, up to two additional cores may be obtained.
(3) Selection of biopsy strategy
For patients with a single unilateral lesion or multiple bilateral lesions, TBx combined with PLBx was considered the preferred biopsy strategy.
For patients with a digital rectal examination suggesting locally advanced disease (cT3) and PSA >50 ng/mL, or for patients who are not candidates for definitive treatment, the number of systematic biopsy cores should be limited to a maximum of six.
The following biopsy strategies did not receive consensus recommendation:
- Six-sector template biopsy: three cores per lobe
- Ginsburg template: ≥12 cores per lobe
- Saturation biopsy at 0.5-mm intervals
(4) Biopsy approach, anesthesia and antibiotic prophylaxis
The transperineal approach is recommended as the standard biopsy route.
For both transrectal and transperineal biopsy, periprostatic nerve block was considered a standard anesthesia technique.
For patients undergoing transperineal biopsy without infection risk factors, the expert panel agreed that prophylactic antibiotics may be omitted.
Potential infection risk factors include:
- Antibiotic use within the previous 6 months
- Recent international travel
- Recent hospitalization
- Non-sterile urine culture
- Urinary tract infection within the previous 6 months
- Poorly controlled diabetes
Core Domain 3: Treatment Planning
(1) Assessment for focal therapy
For patients being evaluated for focal therapy, TBx + PLBx combined with contralateral systematic biopsy (SBx) is considered necessary.
This approach aims not only to adequately characterize the MRI-visible target but also to exclude clinically significant cancer elsewhere in the prostate, particularly on the contralateral side.
(2) Nerve-sparing radical prostatectomy
For patients with a single MRI-visible lesion, TBx + PLBx provides sufficient information for surgical decision-making, and additional systematic or contralateral biopsy is not required.
For patients with bilateral MRI-visible lesions, TBx alone is considered sufficient to support surgical decision-making, allowing contralateral SBx to be omitted.
(3) Lymph-node dissection
For patients with bilateral MRI-visible lesions, TBx ± PLBx provides sufficient information to support decision-making regarding lymph-node dissection.
However, for patients with a single MRI-visible lesion, there is currently no consensus on whether TBx ± PLBx alone provides sufficient information to guide lymph-node dissection.
(4) Whole-gland radiotherapy and/or focal boost radiotherapy
Regardless of whether MRI-visible lesions are unilateral or bilateral, TBx + PLBx provides sufficient information for planning whole-gland radiotherapy and/or focal boost radiotherapy.
(5) ADT duration in patients receiving radiotherapy
For patients undergoing radiotherapy, the pathological information obtained from TBx ± PLBx is considered sufficient to guide decisions regarding the duration of androgen-deprivation therapy (ADT).
Key Takeaway
One of the most important messages from the ProBIOPSY consensus is that prostate biopsy should no longer be viewed as a one-size-fits-all procedure.
Instead, biopsy should be tailored according to:
MRI quality → risk stratification → targeted biopsy → selective addition of PLBx/SBx → treatment-specific biopsy planning.
In other words, standardization does not mean performing the same biopsy in every patient. Rather, it means establishing a standardized framework for determining which biopsy strategy is appropriate for each clinical scenario.
For clearly defined MRI-visible lesions, TBx + PLBx may provide sufficient diagnostic information, whereas patients being considered for focal therapy may require additional contralateral systematic sampling to exclude clinically significant disease elsewhere.
Ultimately, ProBIOPSY represents a shift from “standardized biopsy” toward “treatment-oriented precision biopsy,” aligning the extent and strategy of prostate biopsy with the patient’s individual risk profile, imaging findings, and intended treatment.
【Expert Commentary】
Professor Xingkang Jiang:
This consensus directly addresses many of the controversies surrounding the standardization of prostate biopsy in clinical practice. At first glance, seeking standardization in an era of individualized biopsy may appear contradictory. In reality, however, standardization helps resolve the variability introduced by individualized approaches—using consensus to correct discrepancies and standardized protocols to reduce unwarranted variation.
From an imaging perspective, the consensus places MRI quality at the center of the initial diagnostic pathway. It strongly recommends formal quality assessment of all MRI sequences, with PI-QUAL v2 prioritized as the standard for image-quality evaluation. At the same time, the consensus takes a cautious approach to emerging technologies. Although PSMA PET/CT and micro-ultrasound (micro-US) have demonstrated potential in clinical research, MRI should remain the cornerstone of initial diagnosis until these technologies achieve greater reproducibility, accessibility, and standardization.
From a biopsy-procedure perspective, this is the first international expert consensus to clearly define the terminology of perilesional biopsy (PLBx), its spatial boundary (within 10 mm of the lesion) and a lesion-size-based strategy for determining the number of additional cores. These recommendations help address the substantial procedural heterogeneity that has existed in clinical practice. Given the lower infection risk, shorter hospitalization and better access to anterior prostate lesions associated with the transperineal approach, the consensus establishes transperineal biopsy as the standard route. For patients without infection risk factors undergoing transperineal biopsy, antibiotic prophylaxis may be omitted.
From a treatment-planning perspective, the consensus conveys a particularly important clinical message: there is no one-size-fits-all biopsy strategy. TBx + PLBx can provide sufficient information for most treatment scenarios. However, focal therapy places particularly stringent requirements on comprehensive lesion characterization, making contralateral systematic biopsy essential in this setting. This highlights an important principle for clinicians: biopsy strategy should be determined according to the intended treatment pathway. Clinicians should first clarify whether the patient is likely to undergo surgery, radiotherapy or focal therapy, and then determine the appropriate biopsy extent, rather than applying a uniform “diagnostic package” to every patient.
Looking further, the ProBIOPSY consensus establishes a comprehensive prostate biopsy framework spanning the entire pathway of “initial imaging assessment → biopsy selection → treatment optimization.” By standardizing key clinical decision points, it aims to reduce unnecessary variation and overcome the limited benefits of decision-making based on isolated parameters.
A practical framework can therefore be summarized as:
PI-QUAL v2 to ensure MRI quality → MRI and PI-RADS to accurately characterize lesion burden and distribution → TBx + PLBx as the diagnostic baseline → expansion to systematic biopsy according to the specific treatment scenario.
Within this standardized framework, urologists can then incorporate their clinical expertise, the patient’s overall characteristics and preferences, as well as institutional resources, to refine the biopsy strategy and achieve genuinely individualized decision-making.
For institutions that already perform prostate biopsies, this consensus provides an “operational benchmark” for calibrating existing clinical practice. For centers preparing to establish prostate biopsy services, it serves as a “blueprint” for building a high-quality diagnostic system.
At a time when greater standardization and consistency in prostate cancer care are increasingly needed, the true value of the ProBIOPSY consensus lies in helping bring a standardized pathway for precision prostate biopsy into routine clinical practice, ultimately benefiting a broader population of patients.
Professor Gang Song:
As one of the core experts involved in developing the Panjiayuan Consensus on Prostate Targeted Biopsy, my team and I have long been committed to promoting the standardization and precision of prostate targeted biopsy. The ProBIOPSY consensus aligns closely with the previously published Panjiayuan Consensus on Prostate Targeted Biopsy. One is grounded in an international perspective, while the other focuses on clinical practice in China. Together, they provide a “coordinate system” for standardizing prostate biopsy in the MRI era.
The Panjiayuan Consensus was among the first in China to address key practical questions surrounding targeted biopsy, such as “How many cores should be obtained from a single target?” and “How can the biopsy approach be optimized?” The ProBIOPSY consensus further systematizes these issues at the international level, while extending upstream to imaging quality control and downstream to biopsy strategies tailored to different treatment scenarios, thereby establishing a comprehensive framework spanning “initial imaging assessment → biopsy selection → treatment optimization.”
Of particular importance, the ProBIOPSY consensus clearly emphasizes that “there is no one-size-fits-all biopsy strategy.” Biopsy planning should be determined according to the patient’s intended treatment goal. This principle is closely aligned with the philosophy emphasized in the Panjiayuan Consensus: standardization should guide clinical practice.
The two consensus documents therefore complement each other. The Panjiayuan Consensus addresses “how to perform targeted biopsy in a standardized manner,” while ProBIOPSY further answers the question of “how extensive the biopsy needs to be for different treatment objectives.”
At a time when greater consistency and standardization in prostate cancer care are increasingly needed, the publication of the ProBIOPSY consensus marks an important transition in prostate biopsy worldwide—from “experience-driven” practice toward “standards-driven” practice.
It is also worth noting that a prospective randomized controlled study led by Professor Jiang Xingkang from China was cited as high-level evidence in the consensus. I hope our colleagues across China will actively learn from and apply the key principles of this international consensus while adapting them to the realities of clinical practice in China. In this way, we can help ensure that standardized precision biopsy pathways ultimately benefit more patients.
Conclusion
From MRI quality control to biopsy technique, and from treatment goals back to biopsy planning, the ProBIOPSY consensus establishes a comprehensive and reproducible framework for precision prostate biopsy.
It ensures that “individualization” does not become synonymous with “arbitrariness,” and that “standardization” does not mean “one-size-fits-all.”
Professor Xingkang Jiang
Professor Gang Song
