figure 1. introduction: the following schemes are the …pi‐rads v2 employs thirty‐nine regions:...
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FIGURE 1. INTRODUCTION: The following schemes are the 2015 updated synopsis derived from the updated ITALIAN PROSTATE BIOPSIES GROUP’S GUIDELINES, rated through the GRADE SYSTEM. They have been designed to guide the Physicians through the prostate biopsy/re-biopsy “decision making” process and to aid them during the same procedure. HOW TO READ THE GUIDELINES’ COMPENDIUM: For each “Critical Hotpoint” the weight of every factor to consider will be represented by three different arrows:
ADVISABLE: All the FACTORS/ACTIONS we suggest to evaluate and/or carry out
OPTIONAL: All the FACTORS/ACTIONS we consider optional to evaluate and/or carry out
MODULATING FACTORS: Aspects that might influence the FACTORS/ACTIONS during the clinical practice
Comorbidities Fragilities
Quality of Life Improvements
FIGURE 2. 1st BIOPSY
1. INDICATION TO 1st BIOPSY
* Multiparametric MRI (mpMRI) not recommended in biopsy naïve patients
Prostate Nomograms Free PSA /total PSA < 10%
Prostate Health Index PHI® > 40 PCA3 Score > 35
PSA Velocity > 0.7 ng/ml/yr PSA Density > 0.20
PSA Doubling time < 3yr Positive mpMRI* PIRADS 3
TRUS + Familiar History +
High Risk Populations Pre-BPH Surgery
Any PSA raise from Nadir in 5ARI intake
Digital Rectal Exam (DRE) +
Confirmed Total PSA value > 10 ng/mL
Positive mpMRI* PIRADS 4
1st
B I O P S Y
PSA < 10 ng/mL PSA > 10 ng/mL REPEAT DOSAGE TO CONFIRM VALUE
(if reasonable, subsequent to medical therapy)
FIGURE 3. 1st BIOPSY
2. TRUS-GUIDED BIOPSY TECHNIQUES
TRANSRECTAL TRANSPERINEAL 1st
B I O P S Y
FIGURE 4. 1st BIOPSY
3. NUMBER OF SAMPLED CORES
SAMPLED CORES ≥ 12
PROSTATE VOLUME
AGE >75yr COMORBIDITIES FRAGILITIES
TARGETED CORES: Positive DRE Suspicious Imaging Areas
FIGURE 5. 1st BIOPSY
4. SAMPLED AREAS
* In candidates for BPH Surgery (i.e., laser vaporization)
PERIPHERAL ZONE
ANTERIOR ZONE* SUSPECT AREAS FROM
DRE/TRUS/MRI
1st
B I O P S Y
Comorbidities Fragilities
Quality of Life Improvements
FIGURE 6. RE-BIOPSY
1. INDICATION
Inadequate First Biopsy Set
ASAP Finding
Positive mpMRI PIRADS 4
PSA rising above 10 ng/mL
Active Surveillance Program
DRE Finding modifications
Adverse PSA Kinetics values
Persisted Elevated total PSA
Free PSA / total PSA < 10%
Prostate Health Index (PHI®)
Positive mpMRI PIRADS =3 PCA3 Score > 35
Multifocal HGPIN (> 3 cores)
TRUS +
PSA Density > 0.20
R E B I O P S Y
FIGURE 7. RE-BIOPSY
2. NUMBER OF SAMPLED CORES
3. SAMPLED AREAS
R E B I O P S Y
>12 CORES Anterior zone
included
SATURATION BIOPSY ( > 20 CORES)
MRI-GUIDED BIOPSY (Fusion/In-Bore/cognitive)
SUSPICIOUS TRUS AREA (Targeted Biopsy)
A R E A S
PERIPHERAL ZONE + ANTERIOR ZONE
TARGETED AREAS FROM SUSPICIOUS DRE/TRUS/MRI
(Fusion/In-Bore/cognitive)
FIGURE 8. RE-BIOPSY
4. REBIOPSY TIMING
5. BIOPSY TECHNIQUE
TRANSRECTAL BIOPSY
TRANSPERINEAL BIOPSY
MRI-GUIDED BIOPSY (Fusion/In-Bore/cognitive)
TEMPLATE BIOPSY (Transperineal)
R E B I O P S Y
R E B I O P S Y
NOT BEFORE 3 MONTHS
If negative DRE and/or imaging not strongly suspicious (i.e. PIRADS < 3):
BIOPSY REPEATED UP TO 3 TIMES
(Except for Patients in AS programs)
B I O P S Y
FIGURE 9. PROSTATE BIOPSY: PREPARATION
* Based on patient-adjusted risk **Except for patients contraindications or choice
Viral Markers
Coagulation screening panel
Urine culture
Antibiotic Therapy ≥ 3 Days
Ansiolitic and/or Analgesic administration
General Anesthesia
Providing informed consent
Co-medication History
Anticoagulant or Antiaggregant withdrawal*
(excluding ASA < 100mg/die)
Switching from Antiacoagulant to LMWH*
Antibiotic Prophylaxis
Endocarditis Prophylaxis (where required)
Cleansing Enema
Local Anesthesia** (infiltration +/- anesthetic jelly)
FIGURE 10. PROSTATE BIOPSY: REQUIRED MATERIALS
B I O P S Y
BIOPTIC GUN
TRANSRECTAL Ultrasound probe
16 / 18 Gauge Core Biopsy Needles
Disposable Automatic Core Biopsy Needles
FIGURE 11. Strategies for TRUS-guided prostate biopsy in order to prevent sepsis episodes
Risk Factors
Recurrent Bacterial Prostatitis At least 3 previous antibiotics intake within the last 6
months Previous several TRUS-guided prostate biopsies Active surveillance Recent hospital admission (within last 3 months) Inflammatory chronic bowel disease Immunodeficiency conditions
Stool culture (+ Antiobiogram)
Switching to transperineal biopsy
Urine culture (+ Antibiogram)
Double Antibiotic intake (p.o. Antibiotic + aminoglycosides)
Antibacterical enema
FIGURE 12. Multiparametric prostate MRI, indications, contraindications, technical requirements and reporting system
1. CLINICAL INDICATIONS FIRST BIOPSY: not indicated PREVIOUS NEGATIVE BIOPSY: clinical suspicion of PCa DETECTION mpMRI and
then TRUS or MRI GUIDED BIOPSY (Fusion/In-Bore/cognitive) POSITIVE BIOPSY FOR PCa
ACTIVE SURVEILLANCE: Staging mpMRI to confirm grade and etent CURATIVE INTENT: Staging mpMRI with bone and node in high risk
( From: Barentsz et al. ESUR prostate MR guidelines 2012. Eur Radiol 2012; 22: 746-757)
2. CONTRAINDICATIONS General contraindications to perform an MRI exam (obesity, claustrophobia, pace-makers etc.)
3. LIMITATIONS Possible limitations in case of hip prosthesis
m p
M R I
FIGURE 13. TECHINICAL REQUIREMENTS Barentsz et al. ESUR prostate MR guidelines 2012. Eur Radiol 2012; 22: 746-757 ESUR guidelines. Prostate MRI. http://www.esur.org/esur-guidelines/prostate-mri/
4-6 weeks after biopsy
Scanner 3T with or without endorectal coil Scanner 1.5T with endorectal coil or
≥16-channel pelvic phased array
High resolution T2 weighted sequences
DWI weighted sequence with high b-value (≥1000 s/mm2) and ADC map calculation
DCE-MRI (temporal resolution ≤15s; acquisition for 5 minutes to detect washout;
unenhanced images to detect post-biopsy haematomas
Axial T1 weighted sequences of pelvis for
nodes and bones evaluation
Antiperistaltic drugs (buscopan®, glucagon®)
MRSI
DWI:Diffusionweightedimaging DCE-MRI:Dynamiccontrast-enhancedmagneticresonanceimaging MRSI:Magneticresonancespectroscopicimaging
FIGURE 14. REPORTING SYSTEM
Barentsz et al. ESUR prostate MR guidelines 2012. Eur Radiol 2012; 22: 746-757 ESUR guidelines. Prostate MRI. http://www.esur.org/esur-guidelines/prostate-mri/
Detection and measurement of all prostatic abnormal lesions, with the identification of the index lesion
Localisation scheme
PI-RADS v2 score
Probability of extra-prostatic disease (EPE/SVI)
Incidental findings
EPE:extraprostaticextension SVI:seminalvesiclesinvasion
FIGURE 15. LOCALISATION SCHEME PI‐RADS v2 employs thirty‐nine regions: thirty‐six for the prostate, two for the seminal vesicles and one for the external urethral sphincter. Each lobe (right/left) is diveded in the following regions
APEX
PERIPHERAL ZONE (PZ)
anterior (a) / lateral posterior (pl) / medial posterior (mp)
TRANSITION ZONE (TZ) anterior (a) / posterior (p)
ANTERIOR FIBROMUSCOLAR STROMA (AS)
MIDGLAND PERIPHERAL ZONE (PZ)
anterior (a) / lateral posterior (pl) / medial posterior (mp)
TRANSITION ZONE anterior (a) / posterior (p) ANTERIOR FIBROMUSCOLAR STROMA (AS)
BASE
PERIPHERAL ZONE (PZ)
anterior (a) / lateral posterior (pl)
TRANSITION ZONE (TZ)
anterior (a) / posterior (p)
CENTRAL ZONE (CZ) ANTERIOR FIBROMUSCOLAR STROMA (AS)
SEMINAL VESCICLES EXTERNAL URETHRAL SPHINCTER
(from: ESUR guidelines. Prostate MRI. http://www.esur.org/esur-guidelines/prostate-mri/)
FIGURE 16. PI-RADS v2 SCORE
ESUR guidelines. Prostate MRI. http://www.esur.org/esur-guidelines/prostate-mri/
FIGURE 17. PROSTATE BIOPSY: PREPARATION OF THE SAMPLED SPECIMENS
SAMPLED CORES LENGTH > 10 mm
SEPARATION AND IDENTIFICATION OF
EACH CORE
FORMALDEHYDE FIXATION
EACH SPECIMEN INCLUDED IN A
SINGLE PLASTIC CAGE
SPECIMEN INKING FOR ITS CORRECT
ORIENTATION
SPECIMEN TO
PATHOLOGIST
B I O P S Y
R E P O R T
C L I N I C A L
C L I N I C A L
H I S T O L O G I C A L
H I S T O L O G I C A L
FIGURE 18. PROSTATE BIOPSY: REPORT PREPARATION
Eventual early and late adverse events
Eventual Pharmacological Therapy
Informative Paper (Possible Comorbidities and Side
Effects) Personal records and
clinical data
Number of Positive Cores / Number of Total Cores
Length of Each sampled cores % of Prostate cancer for each
positive core GS Grading for each positive core
(ISUP 2014) % of Gleason Pattern 4
(in GS 3+4 or 4+3) ASAP findings
HGPIN findings Perineural Invasion
Extracapsular Invasion Intraductal Spreading
Presence of Atrofic / Inflammatory findings Explanation for ASAP
classifying Length of Cancer for each
positive core
Immunohistochemical Staining
Seriated Biopsy Evaluation of more Layers of
Biopsy Presence of Neuroendocrine
Differentiation
FIGURE 19. PROSTATE BIOPSY: HISTOLOGICAL REVISION
HISTOLOGY FROM
ANOTHER HOSPITAL FACILITY
ASAP AND/OR FROM ANOTHER HOSPITAL
FACILITY
> 3 CORES WITH MULTIFOCAL HGPIN
PREVIOUS ASAP
PATIENT INCLUDED IN AN ACTIVE
SURVEILLANCE PROGRAM
HISTOLOGICAL REVISION
ANY CASE WHERE HYSTOLOGY MIGHT
CHANGE THERAPEUTIC STRATEGIES
APPENDIX 1: Histological definition of GLEASON GRADE, based on ISUP 2014, and PROGNOSTIC GROUPS, based on WHO 2016
1. INNOVATIONS FROM 2014 ISUP CONSENSUS CONFERENCE
Gleason pattern 3 is limited to discrete glands, either simple or branched, well-formed and divisible from each others Presence of cribriform glands or groups of poorly-formed glands is included in Gleason pattern 4 Occasional/seemingly poorly formed or fused glands between well-formed glands is insufficient for a diagnosis of pattern 4 Glomeruloid glands should be assigned a Gleason pattern 4, regardless of morphology In cases with borderline morphology between Gleason pattern 3 and pattern 4 and crush artifacts, the lower grade should be favored Grading of mucinous carcinoma of the prostate should be based on its underlying growth pattern despite from mucinous presence Gleason Pattern 4 is attributed to ductal carcinoma Small solid cylinders, solid medium to large nests with rosette-like spaces, presence of comedonecrosis, even if focal, should be unequivocal
considered to represent Gleason pattern 5 Gleason Grade should not be assigned to small cell carcinoma Introduction of intraductal carcinoma with presence of large acini and prostatic ducts, preservation of basal cell, solid or dense cribriform
pattern, or loose cribriform or micropapillary pattern plus either nuclear atypia or necrosis. If intraductal carcinoma is found, even without invasive carcinoma, Gleason Grade should not be assigned and a comment either to its invariable association with aggressive prostate cancer end the need of a radical treatment, should be made.
Percentage of Gleason Grade 4 is only limited to Gleason Score 3+4 or 4+3 References:
Epstein JI, Egevad L, Amin MB, Delahunt B, Srigley JR, Humphrey PA; and the Grading Committee. The 2014 International Society of Urological Pathology (ISUP) Consensus Conference on Gleason Grading of Prostatic Carcinoma: Definition of Grading Patterns and Proposal for a New Grading System. Am J Surg Pathol. 2015 Oct 21
World Health Organization for the 2016 edition of pathology and Genetics: Tumours of the Urinary System and Male Genital Organs.
APPENDIX 2. HYSTOLOGICAL DEFINITIONS OF NEW PROGNOSTIC GRADE GROUPS BASED ON WHO 2016
GRADE GROUP 1 (Gleason Score 6): only individual discrete well-formed glands and divisible from each others GRADE GROUP 2 (Gleason Score 3+4 = 7): predominantly well-formed glands with lesser component of poorly- formed/fused/cribriform glands GRADE GROUP 3 (Gleason Score 4+3 = 7): predominantly poorly- formed/fused/cribriform glands with lesser component of well-formed glands GRADE GROUP 4 (Gleason Score 4+4 = 8; 3+5 = 8; 5+3 = 8): only poorly- formed/fused/cribriform glands GRADE GROUP 5 (Gleason Score 9-10): lacks gland formation (or with necrosis) with or without poorly- formed/fused/cribriform glands
The new system based on the GRADE GROUP should be used in the immediate future simultaneously with the Gleason Score. References:
Epstein JI, Egevad L, Amin MB, Delahunt B, Srigley JR, Humphrey PA; and the Grading Committee. The 2014 International Society of Urological Pathology (ISUP) Consensus Conference on Gleason Grading of Prostatic Carcinoma: Definition of Grading Patterns and Proposal for a New Grading System. Am J Surg Pathol. 2015 Oct 21
World Health Organization for the 2016 edition of pathology and Genetics: Tumours of the Urinary System and Male Genital Organs.
APPENDIX 3. HISTOLOGICAL EXAMPLES
APPENDIX 4. EXAMPLE OF A CORRECT HYSTOLOGICAL PROSTATE BIOPSY REPORT
EXAMPLE OF A CORRECT HYSTOLOGICAL PROSTATE BIOPSY REPORT USING BOTH GLEASON SCORE (ISUP 2014) AND PROGNOSTIC GRADE GROUPS 1. Right apex Prostate Cancer Gleason Score 3+3=6 (ISUP 2014); Grade Group 1 (WHO 2016) 10% of biopsy core; tumoral extension 1 mm 2. Lateral right midgland Benign prostate tissue 3. Right base Prostate Cancer Gleason Score Gleason score 4+3=7 (ISUP 2014); Grade Group 3 (WHO 2016) 30% of biopsy core; tumoral extension 5 mm; Gleason Grade 4 70%. 4……. 5……. Comment Singles Gleason Score can be grouped in different Prognostic Grade Groups, from 1 (less aggressive) to 5 (most aggressive), (Eur Urol. 2015 Jul 9. BJU Int. 2013; 111:753-60)
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