Protocol
applies to all carcinomas of the prostate gland.
Procedures
·
Transurethral Prostatic Resection
·
Suprapubic or Retropubic Enucleation (subtotal
prostatectomy)
This protocol is intended to assist pathologists
in providing clinically useful and relevant information as a result of the
examination of surgical specimens. Use of this protocol is intended to be
entirely voluntary. If equally valid protocols or similar documents are
applicable, the pathologist is, of course, free to follow those authorities.
Indeed, the ultimate judgment regarding the propriety of any specific procedure
must be made by the physician in light of the individual circumstances
presented by a specific patient or specimen.
It should be understood that adherence to this
protocol will not guarantee a successful result. Nevertheless, pathologists are
urged to familiarize themselves with the document. Where a physician chooses to
deviate from the protocol based on the circumstances of a particular patient or
specimen, the physician is advised to make a contemporaneous written notation
of the reason for the procedure followed.
The College recognizes that this document may be
used by hospitals, attorneys, managed care organizations, insurance carriers,
and other payers. However, the document was developed solely as a tool to
assist pathologists in the diagnostic process by providing information that
reflects the state of relevant medical knowledge at the time the protocol was
first published. It was not developed for credentialing, litigation, or
reimbursement purposes. The College cautions that any uses of the protocol for
these purposes involve considerations that are beyond the scope of this
document.
I. Needle biopsy back Top Main Page
A. CLINICAL INFORMATION
1. Patient identification
a. Name
b. Identification number
c. Age (birth date)
2. Responsible physician(s)
3. Date of procedure
4. Other clinical information
a. Relevant history (e.g. urinary obstruction)
b. Relevant findings (e.g. digital rectal exam,
PSA, ultrasound, MRI)
c. Clinical diagnosis (e.g. carcinoma)
d. Procedure (e.g. thick core [14 gauge]
transrectal or transperineal biopsy, thin core [18 gauge] image-guided gun
biopsies [sextant, octant, etc]
e. Specific site of needle biopsy (e.g.
peripheral zone, transition zone, apex, base, etc.)
a. Number of
pieces
b. Unfixed/fixed
(specify fixative)
c.
Dimensions
d.
Orientation (if designated by surgeon)
e. Results
of intraoperative consultation
a.
Histologic type (Note A)
b. Gleason
score with primary and secondary grades (Note B)
c.
Quantitation of tumor (e.g. proportion (%) of prostatic tissue involved
by neoplasm) (Note C)
d. Local
invasion [Note D]
(1)
periprostatic fat
(2) seminal
vesicle
e.
Perineural invasion (Note E)
f.
Blood/lymphatic vessel invasion
a. High
grade prostatic intraepithelial neoplasia (PIN) (Note F)
b.
Therapy-related changes
c. Other
a.
Correlation with intraoperative consultation, as appropriate
b.
Correlation with other specimens, as appropriate
c. Correlation with clinical information, as
appropriate
II. Transurethral
prostatic resection back
Top Main
Page
1.
A. CLINICAL INFORMATION
2.
1. Patient identification
a. Name
b.
Identification number
c. Age
(birth date)
3.
4. Other clinical information
a. Relevant
history (e.g. urinary obstruction)
b. Relevant
findings (e.g. digital rectal exam, PSA, ultrasound, MRI)
c. Clinical
diagnosis (e.g. carcinoma)
d. Operative
procedure (transurethral resection: TURP)
e. Operative
findings
4.
1.
Specimen
a.
Organ(s)/tissues(s) included
b.
Unfixed/fixed (specify fixative)
c. Weight
d.
Descriptive features
e. Results
of intraoperative consultation
a. All
grossly suspicious chips (Note G)
b. Specimen
= 12 grams, submit entirely*
c. Specimen
> 12 grams, submit at least 12 grams (about 6-8 cassettes)*
d. Frozen
section tissue fragment(s) (unless saved for special studies)
*Note: If an unsuspected carcinoma is found in
tissue submitted and it involves 5% or less of the tissue examined, all
remaining tissue should be submitted for microscopic examination.
5.
3. Special studies (specify)
6.
7.
C. MICROSCOPIC EVALUATION
8.
1. Tumor
a.
Histologic type (Note A)
b. Gleason
score with primary and secondary grades (Note B)
c.
Quantitation of tumor (Note C)
d. Local
invasion (Note D)
(1) periprostatic fat
(2) seminal
vesicle
e.
Perineural invasion (Note E)
f. Blood/lymphatic vessel invasion
a.
Prostatic intraepithelial neoplasia (PIN) (Note F)
b. Atypical
adenomatous hyperplasia
c.
Therapy-related changes
d. Other(s)
a.
Correlation with intraoperative consultation, as appropriate
b.
Correlation with other specimens, as appropriate
c.
Correlation with clinical information, as appropriate
III. Suprapubic or retropubic
enucleation back Top Main Page
A.
CLINICAL INFORMATION
1. Patient identification
a. Name
b. Identification number
c. Age
(birth date)
a. Relevant
history (e.g. urinary obstruction)
b. Relevant
findings (e.g. palpable mass, elevated PSA, imaging)
c. Clinical
diagnosis
d. Procedure
(e.g. enucleation)
e. Operative
findings
9.
B. MACROSCOPIC EXAMINATION
10.
1. Specimen
a.
Tissue(s)/organ(s) received
b.
Unfixed/fixed (specify fixative)
c. Size
(three dimensions)
d. Weight
e.
Descriptive features (e.g. necrosis, nodular hyperplasia)
f.
Orientation (if indicated by surgeon)
g.
Identification of margins
h. Results
of intraoperative consultation
a.
Location(s)
b. Size(s)
c.
Descriptive features
d. Extent
of invasion (Note H)
a. Tumor or
areas suspicious for tumor
b. Other
representative blocks (approximately 8 cassettes)*
c. Frozen
section tissue fragment(s) (unless saved for special studies)
*Note: If an unsuspected carcinoma is found in
tissue submitted and it involves 5% or less of the tissue examined, additional blocks should be
submitted for microscopic analysis.
11.
C. MICROSCOPIC EVALUATION
1. Tumor
a.
Histologic type (Note A)
b. Gleason score
with primary and secondary grades (Note B)
c.
Quantitation of tumor
(1) size of
tumor(s) two or more dimension(s)
(2)
proportion(%) of specimen involved by tumor
d. Location
of tumor(s)
e. Local
invasion (Note H)
f. Perineural invasion (Note E)
g.
Blood/lymphatic vessel invasion
2. Margins
(Note I)
3. Additional
pathologic findings, if present
a. High
grade prostatic intraepithelial neoplasia (PIN) ( Note E)
b. Atypical
adenomatous hyperplasia.
c. Therapy
related changes
d. Other(s)
4. Results/status
of special studies (specify)
5. Comments
a.
Correlation
with intraoperative consultation, as appropriate
b.
Correlation
with other specimens, as appropriate
c.
Correlation
with clinical information, as appropriate
IV. Radical prostatectomy back Top Main Page
A. CLINICAL
INFORMATION
1. Patient
identification
a. Name
b. Identification number
c. Age (birth date)
2. Responsible physician(s)
3. Date of procedure
4. Clinical
information
a. Relevant history (previous diagnosis,
treatment, includes PSA, imaging)
b. Relevant findings
c. Procedure
(1) perineal procedure
(2) retropubic procedure
i. nerve
sparing
ii. standard
radical
d. Operative findings
e. Anatomic site(s) of specimen(s)
1. Specimen
a.
Organ(s)/tissues included
b. Unfixed/fixed (specify fixative)
c. Opened/unopened
d. Orientation (if indicated by surgeon)
e. Structures included in specimen
(1) prostate
(2) seminal vesicles
(3) segments of vasa deferentia
(4) bladder neck
(5) urethra
(6) other(s) (specify)
f. Size (three dimensions)
g. Weight (prostate separately)
h. Obstruction of urethra (partial/complete)
i. Descriptive features (e.g. necrosis, nodular hyperplasia)
j. Results of intraoperative consultation
2. Tumor (if identified)
a. Location(s)
b. Size(s)
c. Descriptive features
d. Extent of local invasion
3. Regional lymph nodes
a. Location
b. Number (each location, if possible)
4. Blocks submitted for microscopic evaluation (include diagrams, if
appropriate) (Note G)
a. Tumor(s) (each grossly recognizable tumor)
b. Blocks from other anatomic locations within the prostate (to
evaluate for multicentricity)
c. Blocks to determine extent of invasion (Note H)
(1) prostatic capsule and periprostatic tissue
adjacent to each tumor including inked margins
(2) seminal vesicles
(3) periprostatic tissue at bases of seminal
vesicles
d. Apex (Note I)
e. Vesical
neck margin
f. All
lymph nodes
g. Frozen
section tissue fragment(s)(unless saved for special studies)
h. Other
tissues (specify)
5.Special studies (specify) (e.g. immunohistochemistry,
ploidy analysis, S phase fraction)
1. Tumor
a.
Histologic type (Note A)
b. Gleason score with primary and secondary
grades (Note B)
c.
Location(s)
d.
Extent of local invasion (Note H)
(1) Extraprostatic extension
(2) Seminal vesicle involvement
2. Margins (location and extent of margins
involved with tumor) (see Note I)
3. Regional
lymph nodes
a. Number (specify
location)
b. Number involved by tumor
(1) specify location, if possible
(2) size of metastatic deposit (i.e. if <2 mm =
micrometastasis)
(3) extracapsular extension, if present
4. Additional
pathologic findings, if present
a. High grade intraepithelial neoplasia (PIN)
b. Therapy-related changes
c. Other(s)
5. Metastasis
to other organ(s) or structure(s) (specific sites)
6. Other
tissue(s)/organ(s)
7. Results/status
of special studies (specify)
8. Comments
a.
Correlation with intraoperative consultation, as appropriate
b.
Correlation with other specimens, as appropriate
c.
Correlation with clinical information, as appropriate
EXPLANATORY NOTES
A.
Histologic Type back Top Main Page
This
protocol applies only to carcinomas of the prostate gland. The histologic
classification of prostate carcinoma is recommended and shown below.(1)
However, this protocol does not preclude the use of other systems of
classification or histologic types. Mixtures of different histologic types
should be indicated.
Histologic Classification of Carcinoma of the
Prostate
·
Adenocarcinoma (conventional, not otherwise
specified)
·
Special variants of adenocarcinoma and other
carcinomas
-
Prostatic duct adenocarcinoma
- Mucinous (colloid) adenocarcinoma
- Signet ring cell carcinoma
- Adenosquamous carcinoma
- Squamous cell carcinoma
- Basaloid and adenoid cystic carcinoma
- Transitional cell carcinoma
- Small cell carcinoma
- Sarcomatoid carcinoma
- Lymphoepithelioma-like carcinoma
- Undifferentiated carcinoma, not otherwise
specified
The
Gleason grading system is recommended for use in all prostatic cancer
specimens.(2-6) The Gleason score is the sum of the primary (most predominant)
Gleason grade and the secondary (second most predominant) Gleason grade. Where
no secondary Gleason grade exists, the primary Gleason grade is doubled to
arrive at a Gleason score. The primary and secondary grades should be reported
in parenthesis after the Gleason score, i.e. Gleason score 7(3,4) or 7(3+4). In
needle biopsy specimens when there are more than two patterns present and the
worst grade is neither the predominant nor the secondary grade, the predominant
and the highest grade should be chosen to arrive at a score (e.g. 60% grade 3,
30% grade 2, 10% grade 4 = score 3+4 = 7). When multiple needle biopsy
specimens are submitted and they have differing Gleason scores, an overall
(composite) Gleason score for the case should be clearly reported in a note.
In
radical prostatectomy specimens, where more than one separate tumor is
identified, the Gleason scores of the individual tumors may be reported
separately or at the very least the Gleason score of the most significant
lesion should be recorded. For instance if there is a large Gleason score 5
transition zone cancer and a separate smaller Gleason score 7 peripheral zone
cancer, both scores or at least the latter score should be reported rather than
the scores being averaged.
Another
grading system may be used according to institutional preference (e.g. WHO, MD
Anderson) but the Gleason score must be included to facilitate comparison of
data.
Gleason Grades (Patterns):
·
Grade 1- single, separate, closely packed acini
·
Grade 2-single acini, more loosely arranged,
less uniform
·
Grade 3-single acini of variable size, and
separation, cribriform and papillary patterns
·
Grade 4-irregular masses of acini and fused
epithelium, can show clear cells
·
Grade 5-anaplastic carcinoma
Gleason
scores may be grouped into differentiation (prognostic) categories:
2-4 Well
differentiated
5-6 Moderately
well differentiated
7 Moderately
poorly differentiated
8-10 Poorly differentiated or
2-6 Well
differentiated
7 Moderately
differentiated
8-10
Poorly differentiated
There
are many methods of estimating the amount of tumor in prostatic
specimens.(7-16) In core biopsies, the absolute number and/or percentage of cores
involved, the linear extent of involvement in millimeters and the proportion
(percent)of surface area of prostatic tissue involved may be used. In
transurethral resectates, the proportion (percent) of tissue involved by
carcinoma and the number of positive chips (foci) may be used. In subtotal and
radical prostatectomy specimens, the percentage of tissue involved by tumor can
also be “eyeballed”. Additionally, in these latter specimens it may be possible
to measure a dominant tumor nodule in at least two dimensions and to indicate
the number of blocks involved by tumor over the total number of prostatic
blocks submitted.
For
the purpose of this protocol, it is recommended that at the very least, the
proportion (percentage) of prostatic tissue involved by tumor be included for
all specimens.
D. Local Invasion in Needle
Biopsies back Top Main Page
Occasionally
in needle biopsies, periprostatic fat is present and involved by tumor.(7-9)
This observation should be noted since it indicates that the tumor is at least
stage pT3a. Furthermore, if seminal vesicle tissue is present [either
serendipitously or intentially as in a directed biopsy] and involved by tumor,
this should be reported since it indicates that the tumor is at least pT3b.
Seminal vesicle invasion is defined by involvement of the muscular
wall.(7-9,17) At times, especially in needle biopsy specimens, it is difficult
to distinguish between seminal vesicle and ejaculatory duct-type tissue. It is
important not to over-interpret ejaculatory duct as seminal vesicle-type
tissue. Ejaculatory duct epithelium is generally surrounded by loose fibrous
connective tissue with abundant blood vessels, whereas the seminal vesicle
epithelium is surrounded by smooth muscle bundles constituting its wall.
E. Perineural Invasion back
Top Main
Page
Perineural
invasion on core needle biopsies has been associated with a high risk of
extraprostatic extension in some studies although the exact prognostic
significance remains to be determined.(18-21) Perineural invasion has also been
found to be an independent risk factor for predicting an adverse outcome in
patients treated with external beam radiation. The value of perineural invasion
as an independent prognostic factor, however, has been questioned in a
multi-variate analysis.(22)
F. Prostatic Intraepithelial
Neoplasia (PIN) back
Top Main
Page
The
diagnostic term PIN (prostatic intraepithelial neoplasia), unless qualified,
refers to high grade PIN.(23) Low grade PIN is not reported. The presence of
PIN should be reported in all biopsy specimens including those with
carcinoma.(9) High grade PIN in a biopsy without evidence of carcinoma is a
significant risk factor for the presence of carcinoma on subsequent
biopsies.(24,25) The reporting of high grade PIN in prostatectomy specimens is
optional.
G. Submission of Tissue for
Microscopic Evaluation in Transurethral Resection and Radical Prostatectomy
Specimens.back Top Main Page
Specimens
weighing (<=12 grams should be submitted in their entirety, usually in 6-8
cassettes.(26,27) For specimens > 12 grams, the initial 12 grams are submitted
(6-8 cassettes) and one cassette for every additional 5 grams may be submitted.
In
general, random chips are submitted, however, if some chips are firmer or have
a yellow or orange-yellow appearance, they should be preferentially submitted.
In
radical prostatectomy specimens with no grossly visible tumor, the specimen may
be submitted in its entirety or partially sampled in a systematic fashion. One
method of partial sampling involves submitting the entire apical segment and
bladder neck along with alternating posterior transverse sections. Two or three
random blocks demonstrating the anterior surface are also submitted along with
samples of each seminal vesicle including their juncture with prostate proper.
H. Extraprostatic Extension back Top Main Page
Extraprostatic
extension(EPE)is the preferred term for the presence of tumor beyond the
confines of the prostate gland.(8,28) Tumor abutting on or admixed with fat
constitutes extraprostatic extension. EPE may also be reported when tumor
involves perineural spaces in the neurovascular bundles, even in the absence of
periprostatic fat involvement. In certain locations, such as the anterior
prostate and bladder neck regions, there is a paucity of fat and in these
locations, EPE is determined when the tumor extends beyond the confines of the
normal glandular prostate. Sometimes there is a distinct bulging tumor nodule
which may be associated with a desmoplastic stromal reaction.
The
entire surface of the prostate should be inked to evaluate the surgical
margins.(29-36) Usually, surgical margins should be designated as “negative” if
tumor is not present at the inked margin and is “positive” if tumor cells touch
the ink at the margin. Positive surgical margins should not be interpreted as
extra-prostatic extension. If the surgical margin is positive, the pathologist
should state this explicitly, although this finding is not relied upon for
pathologic staging. The specific locations of the positive margins should be
documented and there should be some indication (e.g. number of positive blocks,
linear extent in millimeters) of the extent of margin positivity.
The
apex should be closely examined because of its unusual susceptibility to
positive margins.(29-31) At the apex, tumor admixed with skeletal muscle
elements does not constitute extraprostatic extension. The apical and bladder
neck surgical margins should be sectioned entirely, preferably with a
perpendicular orientation. Microscopic involvement of bladder neck muscle fibers
in radical prostatectomy specimens should not be equated with a pT4
designation. The latter generally requires gross involvement of the bladder
neck.
The
protocol recommends the use of the TNM Staging System for carcinoma of the
prostate of the American Joint Committee on Cancer (AJCC) and the International
Union Against Cancer (UICC) as shown below.(37,38)
By
AJCC/UICC convention, the designation “T” of the TNM classification refers
exclusively to the first resection of a primary tumor. The prefix symbol “p”
refers to the pathologic classification of the TNM (pTNM), as opposed to the
clinical classification. Pathologic classification is based on gross and microscopic
examination. Therefore, pT entails a resection of the primary tumor or biopsy
adequate to evaluate the highest pT category; pN entails removal of nodes
adequate to validate lymph node metastasis; and pM implies microscopic
examination of distant lesions. Clinical classification (cTNM) is usually
carried out by the referring physician before treatment during initial
evaluation of the patient or when pathologic classification is not possible.
Primary Tumor, Clinical (cT)
TX Primary
tumor cannot be assessed
T0 No
evidence of primary tumor
T1 Clinically
inapparent tumor not palpable or visible by imaging
T1a Tumor incidental histologic
finding in 5% or less of tissue resected
T1b Tumor incidental histologic
finding in more than 5% of tissue resected
T1c Tumor identified by needle biopsy
(e.g. because of elevated PSA)
T2 Tumor
confined within the prostate*
T2a Tumor involves one lobe
T2b Tumor involves both lobes
T3 Tumor
extends through the prostatic capsule**
T3a Extracapsular extension
(unilateral or bilateral)
T3b Tumor invades the seminal vesicle(s)
T4 Tumor
is fixed or invades adjacent structures other than the seminal vesicles,
bladder neck, external sphincter, rectum, levator muscles and/or pelvic
wall
12.
*
Tumor found in one or both lobes by needle biopsy, but not palpable or visible
by imaging, is classified as T1c.
**
Invasion into the prostatic apex or into (but not beyond) the prostatic capsule
is not classified as T3, but as T2. Tumor extension into periprostatic soft
tissue, as opposed to organ confined cancer (T2), is T3.
Primary Tumor, Pathologic (pT)
pT2*** Organ
confined
pT2a Unilateral
pT2b Bilateral
pT3 Extraprostatic
extension
pT3a Extraprostatic
extension
pT3b Seminal
vesicle extension
pT4**** Invasion
of bladder, rectum
***
There is no pathologic T1 category.
****
Invasion of bladder indicates direct spread into the wall of the urinary
bladder. The basal prostatic stroma blends imperceptively into the bladder
neck musculature and in most instances
involvement of the bladder neck margin in a radical prostatectomy does not
indicate that the tumor is pT4.
Regional Lymph Nodes (N)
NX Regional
lymph nodes cannot be assessed
N0 No
regional lymph node metastasis
N1 Metastasis
in regional lymph node or nodes
Distant Metastasis† (M)
MX Distant
metastasis cannot be assessed
M0 No
distant metastasis
M1 Distant
Metastasis
M1a - non-regional lymph node(s)
M1b - bone(s)
M1c - other site(s)
† When more than one site of
metastasis is present, the most advanced category (pM1c) is used.
Stage
Groupings (TNM)
Grade
Stage I T1a N0 M0 G1
Stage II T1a
N0 M0
G2, G3-4
T1b N0 M0 Any G
T1c N0 M0
Any G
T1 N0
M0 Any
G
T2 N0 M0
Any G
Stage III T3
N0 M0
Any G
Stage IV T4
N0 M0
Any G
Any T N1 M0
Any G
Any T Any N M1
Any G
Residual Tumor in the
Patient
Tumor
remaining in a patient after therapy with curative intent (e.g., surgical
resection) is categorized by a system known as R classification, shown below.
This classification may be used by the surgeon to indicate the known or assumed
status of the completeness of the surgical resection. For the pathologist, the R
classification is relevant only to the margins of surgical resection specimens;
patients with tumor involving the resection margins on pathologic examination
may be assumed to have residual tumor. Such patients may be classified as to
whether the involvement is macroscopic or microscopic.
RX Presence
of residual tumor cannot be assessed
R0 No
residual tumor
R1 Microscopic
residual tumor
R2 Macroscopic
residual tumor.
Residual Tumor in a Specimen
Tumor
remaining in a resection specimen following previous (neoadjuvant) treatment of
any type (radiation therapy alone, chemotherapy therapy alone, or any combined
modality treatment) is codified by the TNM using a prescript “y” to indicate
the post-treatment status of the tumor (e.g., ypT1). The classification of
residual disease may be a predictor of postoperative outcome. In addition, the
ypTNM classification provides a standardized framework for the collection of
data needed to accurately evaluate new neoadjuvant therapies.
Locally Recurrent Tumor
Tumor
that is locally recurrent after a documented disease-free interval following
surgical resection is classified according to the TNM categories but modified
with the prefix “r” (e.g., rpT1).
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