Protocol for the Examination of Specimens From Patients With Carcinoma of the Prostate Gland

The College of American Pathologists offers these protocols to assist pathologists in providing clinically useful and relevant information when reporting results of surgical specimen examinations. The College regards the reporting elements in the “Surgical Pathology Cancer Case Summary (Checklist)” portion of the protocols as essential elements of the pathology report. However, the manner in which these elements are reported is at the discretion of each specific pathologist, taking into account clinician preferences, institutional policies, and individual practice.The College developed these protocols as an educational tool to assist pathologists in the useful reporting of relevant information. It did not issue the protocols for use in litigation, reimbursement, or other contexts. Nevertheless, the College recognizes that the protocols might be used by hospitals, attorneys, payers, and others. Indeed, effective January 1, 2004, the Commission on Cancer of the American College of Surgeons mandated the use of the checklist elements of the protocols as part of its Cancer Program Standards for Approved Cancer Programs. Therefore, it becomes even more important for pathologists to familiarize themselves with these documents. At the same time, the College cautions that use of the protocols other than for their intended educational purpose may involve additional considerations that are beyond the scope of this document.This protocol applies to invasive carcinomas of the prostate gland. The 7th edition TNM staging system for carcinoma of the prostate of the American Joint Committee on Cancer (AJCC) and the International Union Against Cancer (UICC) is recommended.Select a Single Response Unless Otherwise Indicated* Data elements with asterisks are not required. However, these elements may be clinically important but are not yet validated or regularly used in patient management.Note: The Gleason grade and score and the tumor extent measures should be documented for each positive specimen (container). The essential information in each specimen could be conveyed with a simple diagnostic line such as, “Adenocarcinoma, Gleason grade 3 + 4 = score of 7, in 1 of 2 cores, involving 20% of needle core tissue, and measuring 4 mm in length.” (See “Explanatory Notes.”)Histologic Type (note A)__ Adenocarcinoma (acinar, not otherwise specified)__ Other (specify): ____Histologic Grade (note B)Gleason Pattern(If 3 patterns present, use most predominant pattern and worst pattern of remaining 2)__ Not applicable__ Cannot be determinedPrimary (Predominant) Pattern__ Grade 1__ Grade 2__ Grade 3__ Grade 4__ Grade 5Secondary (Worst Remaining) Pattern__ Grade 1__ Grade 2__ Grade 3__ Grade 4__ Grade 5Total Gleason Score: __Tumor Quantitation (note C)Number cores positive: __Total number of cores: __ andProportion (percentage) of prostatic tissue involved by tumor: __orNumber cores positive: __Total number of cores: __ andTotal linear millimeters of carcinoma: __ mmTotal linear millimeters of needle core tissue: __ mmorNumber cores positive: __Total number of cores: __ andProportion (percentage) of prostatic tissue involved by tumor: __ andTotal linear millimeters of carcinoma: __ mmTotal linear millimeters of needle core tissue: __ mm*Proportion (percentage) of prostatic tissue involved by tumor for core with the greatest amount of tumor: __%Periprostatic Fat Invasion (document if identified) (note D)*__ Not identified__ PresentSeminal Vesicle Invasion (document if identified) (note D)*__ Not identified__ Present*Lymph-Vascular Invasion*__ Not identified*__ Present*__ Indeterminate*Perineural Invasion (note E)*__ Not identified*__ Present*Additional Pathologic Findings (select all that apply)*__ None identified*__ High-grade prostatic intraepithelial neoplasia (PIN) (note F)*__ Atypical adenomatous hyperplasia (adenosis)*__ Inflammation (specify type): ____*__ Other (specify): ____*Comment(s): ____Select a Single Response Unless Otherwise Indicated* Data elements with asterisks are not required. However, these elements may be clinically important but are not yet validated or regularly used in patient management.Procedure__ Transurethral prostatic resection (note G)__ Enucleation__ Other (specify): ______ Not specifiedSpecimen SizeWeight: __ gSize (enucleation specimens only): __ × __ × __ cmHistologic Type (note A)__ Adenocarcinoma (acinar, not otherwise specified)__ Other (specify): ____Histologic Grade (note B)Gleason Pattern(If 3 patterns present, use most predominant pattern and worst pattern of remaining 2)__ Not applicable__ Cannot be determinedPrimary (Predominant) Pattern__ Grade 1__ Grade 2__ Grade 3__ Grade 4__ Grade 5Secondary (Worst Remaining) Pattern__ Grade 1__ Grade 2__ Grade 3__ Grade 4__ Grade 5Total Gleason Score: __Tumor Quantitation: TUR Specimens (note C)Proportion (percentage) of prostatic tissue involved by tumor: __%__ Tumor incidental histologic finding in no more than 5% of tissue resected with Gleason score 2 to 6 (cT1a)__ Tumor incidental histologic finding in more than 5% of tissue resected or Gleason score 7 to 10 (cT1b)*Number of positive chips: __*Total number of chips: __Tumor Quantitation: Enucleation Specimens (note C)Proportion (percentage) of prostatic tissue involved by tumor: __*__ Tumor size (dominant nodule, if present): *Greatest dimension: __ cm *Additional dimensions: __ × __ cmPeriprostatic Fat Invasion (document if identified) (note D)*__ Not identified__ PresentSeminal Vesicle Invasion (document if identified) (note D)*__ Not identified__ Present*Lymph-Vascular Invasion*__ Not identified*__ Present*__ Indeterminate*Perineural Invasion (note E)*__ Not identified*__ Present*Additional Pathologic Findings (select all that apply)*__ None identified*__ High-grade prostatic intraepithelial neoplasia (PIN) (note F)*__ Atypical adenomatous hyperplasia (adenosis)*__ Nodular prostatic hyperplasia*__ Inflammation (specify type): ____*__ Other (specify): ____*Comment(s): ____Select a Single Response Unless Otherwise Indicated* Data elements with asterisks are not required. However, these elements may be clinically important but are not yet validated or regularly used in patient management.Procedure (note G)__ Radical prostatectomy__ Other (specify): ______ Not specifiedProstate Size (note G)Weight: __ gSize: __ × __ × __ cmLymph Node Sampling (note G)__ No lymph nodes present__ Pelvic lymph node dissectionHistologic Type (note A)__ Adenocarcinoma (acinar, not otherwise specified)__ Prostatic duct adenocarcinoma__ Mucinous (colloid) adenocarcinoma__ Signet-ring cell carcinoma__ Adenosquamous carcinoma__ Small cell carcinoma__ Sarcomatoid carcinoma__ Undifferentiated carcinoma, not otherwise specified__ Other (specify): ____Histologic Grade (note B)Gleason Pattern(If 3 patterns are present, record the most predominant and second-most common patterns; the tertiary pattern should be recorded if higher than the primary and secondary patterns, but it is not incorporated into the Gleason score)__ Not applicable__ Cannot be determinedPrimary Pattern__ Grade 1__ Grade 2__ Grade 3__ Grade 4__ Grade 5Secondary Pattern__ Grade 1__ Grade 2__ Grade 3__ Grade 4__ Grade 5Tertiary Pattern__ Grade 3__ Grade 4__ Grade 5__ Not applicableTotal Gleason Score: __Tumor Quantitation (note C)Proportion (percentage) of prostate involved by tumor: __%and/orTumor size (dominant nodule, if present): Greatest dimension: __ mm Additional dimensions: __ × __ mmExtraprostatic Extension (select all that apply) (note H)__ Not identified__ Present __ Focal *__ Specify site(s): ____ __ Nonfocal (established, extensive) *__ Specify site(s): ______ IndeterminateSeminal Vesicle Invasion (invasion of muscular wall required) (note D)__ Not identified__ Present__ No seminal vesicle presentMargins (select all that apply) (note I)__ Cannot be assessed*__ Benign glands at surgical margin__ Margins uninvolved by invasive carcinoma__ Margin(s) involved by invasive carcinoma *__ Unifocal *__ Multifocal __ Apical __ Bladder neck __ Anterior __ Lateral __ Posterolateral (neurovascular bundle) __ Posterior __ Other(s) (specify): ____Treatment Effect on Carcinoma (select all that apply)__ Not identified__ Radiation therapy effect present__ Hormonal therapy effect present__ Other therapy effect(s) present (specify): ____Lymph-Vascular Invasion__ Not identified__ Present__ Indeterminate*Perineural Invasion (note E)*__ Not identified*__ PresentPathologic Staging (pTNM) (note K)TNM Descriptors (required only if applicable) (select all that apply)__ m (multiple)__ r (recurrent)__ y (posttreatment)Primary Tumor (pT)__ Not identified__ pT2: Organ confined*__ pT2a: Unilateral, involving one-half of 1 side or less*__ pT2b: Unilateral, involving more than one-half of 1 side but not both sides*__ pT2c: Bilateral disease__ pT3: Extraprostatic extension__ pT3a: Extraprostatic extension or microscopic invasion of bladder neck__ pT3b: Seminal vesicle invasion__ pT4: Invasion of rectum, levator muscles and/or pelvic wall (note J)Note: There is no pathologic T1 classification. Subdivision of pT2 disease is problematic and has not proven to be of prognostic significance.Regional Lymph Nodes (pN)__ pNX: Cannot be assessed__ pN0: No regional lymph node metastasis__ pN1: Metastasis in regional lymph node or nodes Specify: Number examined: __ Number involved: __ Diameter of largest lymph node metastasis: __ (mm)Distant Metastasis (pM)__ Not applicable__ pM1: Distant metastasis__ pM1a: Nonregional lymph nodes(s)__ pM1b: Bone(s)__ pM1c: Other site(s) with or without bone diseaseNote: When more than 1 site of metastasis is present, the most advanced category is used. pM1c is most advanced.*Additional Pathologic Findings (select all that apply)*__ None identified*__ High-grade prostatic intraepithelial neoplasia (PIN) (note F)*__ Inflammation (specify type): ____*__ Atypical adenomatous hyperplasia (adenosis)*__ Nodular prostatic hyperplasia*__ Other (specify): ____*Ancillary Studies*Specify: ____*__ Not performed*Comment(s): ____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 ProstateAdenocarcinoma (conventional, acinar)Special variants of adenocarcinoma and other carcinomasProstatic duct adenocarcinomaMucinous (colloid) adenocarcinomaSignet-ring cell carcinomaAdenosquamous carcinomaSquamous cell carcinoma†Basaloid (basal cell) and adenoid cystic carcinoma†Urothelial (transitional cell) carcinoma†Small cell carcinomaSarcomatoid carcinomaLymphoepithelioma-like carcinoma†Undifferentiated carcinoma, not otherwise specified† This protocol does not apply to these carcinomas.The Gleason grading system is recommended for use in all prostatic specimens containing adenocarcinoma, with the exception of those showing treatment effects, usually in the setting of androgen withdrawal.23 Gleason score is an important parameter used in nomograms, such as the Kattan nomograms,45 and the Partin tables,6 which guide individual treatment decisions. Readers are referred to the recommendations of a recent consensus conference dealing with the contemporary usage of the Gleason system.7 The Gleason score is the sum of the primary (most predominant in terms of surface area of involvement) 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 addition to the Gleason score, that is, Gleason score 7 (3 + 4) or 7 (4 + 3).In needle biopsy specimens, it is recommended that Gleason scores be assigned for each specimen (container). Alternatively, a Gleason score may be given for each positive, intact core in a container.In needle biopsy specimens where there is a minor secondary component (<5% of tumor) and where the secondary component is of higher grade, the latter should be reported. For instance, a case showing more than 95% Gleason 3 and less than 5% Gleason 4 should be reported as Gleason score 7 (3 + 4). Conversely, if a minor secondary pattern is of lower grade, it need not be reported. For instance, where there is greater than 95% Gleason score 4 and less than 5% Gleason 3, the score should be reported as Gleason 8 (4 + 4).In needle biopsy specimens where more than 2 patterns are present, and the worst grade is neither the predominant nor the secondary grade, the predominant and highest grade should be chosen to arrive at a score (eg, 75%, grade 3; 20%–25%, grade 4; <5%, grade 5 is scored as 3 + 5 = 8). This approach has been validated in a large clinical series.8Rules of grading, similar to the above, apply to transurethral resection and enucleation (simple prostatectomy) specimens.Tertiary Gleason patterns are common in radical prostatectomy specimens. When Gleason pattern 5 is present as a tertiary pattern, its presence should be recognized in the report. For instance, in a situation where the primary Gleason grade is 3, the secondary is 4, and there is less than 5% Gleason 5, the report should indicate a Gleason score of 7 (3 + 4) with tertiary Gleason pattern 5.For radical prostatectomy specimens, Gleason score should be assigned to the dominant nodule(s), if present. Where more than one separate tumor is clearly identified, the Gleason scores of individual tumors can be recorded separately, or, at the very least, a Gleason score of the dominant or most significant lesion should be recorded. For instance, if there is a large Gleason score 4 (2 + 2) transition zone tumor and a separate, smaller Gleason score 8 (4 + 4), peripheral zone cancer, both scores should be reported, or, at the very least, the latter score should be reported rather than these scores being averaged.There are many methods of estimating the amount of tumor in prostatic specimens.9–17 For needle core biopsy specimens, it is suggested that the number of positive cores out of the total number of cores always be reported, except in situations where fragmentation precludes accurate counting. The estimated proportion (percentage) of prostatic tissue involved by tumor and/or the linear millimeters of the tumor should also be reported. Reporting of the positive core with the greatest percentage of tumor is an option. In transurethral resections, the proportion (percentage) of tissue involved by carcinoma should always be reported, in addition to the number of positive chips and the ratio or percentage of positive chips to total chips. In subtotal and radical prostatectomy specimens, the percentage of tissue involved by tumor can also be eyeballed by simple visual inspection. Additionally, in these latter specimens, it may be possible to measure a dominant tumor nodule in at least 2 dimensions and/or to indicate the number of blocks involved by tumor out of the total number of prostatic blocks submitted.Occasionally, in needle biopsies, periprostatic fat is present and involved by tumor.9 This observation should be noted because it indicates that the tumor is at least pT3a in the TNM system. Furthermore, if seminal vesicle tissue is present (either unintentionally or intentionally, as in a directed biopsy) and involved by tumor, this should be reported because it indicates that the tumor is at least pT3b. Seminal vesicle invasion is defined by involvement of the muscular wall.918 At times, especially in needle biopsy specimens, it is difficult to distinguish between seminal vesicle and ejaculatory duct tissue. It is important not to overinterpret the ejaculatory duct as the seminal vesicle because involvement of the former by tumor does not constitute pT3b disease. If there is doubt as to whether the involved tissue represents the seminal vesicle or the ejaculatory duct, then invasion of the seminal vesicle should not be definitively diagnosed.Perineural invasion in needle core biopsies has been associated with extraprostatic extension in some correlative radical prostatectomy studies, although its exact prognostic significance remains to be determined.91419–22 Perineural invasion has also been found to be an independent risk factor, in some studies, for predicting an adverse outcome in patients treated with external beam radiation19 but not for patients treated with brachytherapy or radical prostatectomy.20 The value of perineural invasion as an independent prognostic factor has been questioned in a multivariate analysis.22The diagnostic term prostatic intraepithelial neoplasia (PIN), unless qualified, refers to high-grade PIN. Low-grade PIN is not reported. The presence of an isolated PIN (PIN in the absence of carcinoma) should be reported in all biopsy specimens.9 The reporting of PIN in biopsies with carcinoma is considered optional. High-grade PIN in a biopsy without evidence of carcinoma has, in the past, been a risk factor for the presence of carcinoma on subsequent biopsies, but the magnitude of the risk has diminished, and, in some studies, high-grade PIN was not a risk factor at all, unless multiple cores were positive for PIN.23–26 The reporting of high-grade PIN in prostatectomy specimens is optional.Transurethral resection specimens that weigh 12 g or less should be submitted in their entirety, usually in 6 to 8 cassettes.27 For specimens that weigh more than 12 g, the initial 12 g are submitted (6 to 8 cassettes), and 1 cassette may be submitted for every additional 5 g.In general, random chips are submitted; however, if some chips are firmer or have a yellow or orange-yellow appearance, they should be submitted preferentially.If an unsuspected carcinoma is found in tissue submitted, and it involves 5% or less of the tissue examined, the remaining tissue may be submitted for microscopic examination, especially in younger patients.A radical prostatectomy specimen may be submitted in its entirety or partially sampled in a systematic fashion.2829 For partial sampling in the setting of a grossly visible tumor, the tumor and associated periprostatic tissue and margins, along with the entire apical and bladder neck margins and the junction of each seminal vesicle with the prostate proper, should be submitted. If there is no grossly visible tumor, a number of systematic sampling strategies may be used. One that yields excellent prognostic information involves submitting the posterior aspect of each transverse slice along with a mid anterior each The anterior sampling the in the transition zone and The entire apical and bladder neck margins and the junction of each seminal vesicle with the prostate should also be extension is the term for the presence of tumor beyond the of the prostate Tumor with fat extraprostatic Tumor involving tissue in the of fat or even in the absence of between the tumor and the indicates Extraprostatic extension may also be reported when the tumor involves perineural in the even in the absence of periprostatic fat In such as the anterior and apical prostate and bladder neck there is a of and in these is when the tumor beyond the of the In the it is difficult to there is a tumor nodule, which may be associated with a The specific and the number of of are useful to report. Descriptors of should be used. Focal with only a glands being the prostate or a tumor involving less than 1 in 1 or 2 is more beyond the prostatic entire surface of the prostate should be to the surgical surgical margins should be as if tumor is not present at the and as positive if tumor the at the When tumor is very to an surface but is not in with the the is considered surgical margins should not be as extraprostatic margins are positive in the setting of 1, and If the surgical finding is positive, the should that although this finding is not on for pathologic The specific of the positive margins should be reported, and it should be whether or is present at each site of There should be some of the extent of At the International of Pathology on and Staging of Radical it was recommended that the extent of a positive be reported as millimeters of should be because it is a common site of At the tumor with elements does not constitute extraprostatic The apical and bladder neck surgical margins should be submitted with a involvement of bladder neck in radical prostatectomy specimens indicates pT3a protocol the use of the TNM Staging for carcinoma of the prostate of the and the the refers to a primary tumor that has not been The refers to the pathologic classification of the as to the clinical and is on and microscopic a resection of the primary tumor or a biopsy to the highest of nodes to lymph node and microscopic of classification is usually out by the initial of the or when pathologic classification is not staging is usually surgical resection of the primary Pathologic staging on pathologic of the extent of whether or not the primary tumor has been If a tumor is not resected for (eg, when and if the highest and or the category of the tumor can be the for pathologic classification and staging have been without total of the primary and pT3b are in 2 tumor be No evidence of primary tumor neither nor visible by Tumor incidental histologic finding in 5% or less of tissue Tumor incidental histologic finding in more than 5% of tissue Tumor by needle biopsy (eg, because of prostate specific Tumor Tumor involves one-half of one or Tumor involves more than one-half of one but not both Tumor involves both Tumor the prostate extension or microscopic bladder neck Tumor seminal Tumor is or other than seminal bladder external rectum, levator and/or pelvic Tumor found in one or both by needle biopsy that is not or visible by is as Invasion into the prostatic or into not the prostatic is not as but as and Gleason of of TNM or the m and the and a are used. they not the they indicate that need separate m indicates the presence of multiple primary tumors in a site and is recorded in y indicates those in which classification is or initial therapy or both and The or category is by a y The or the extent of tumor present at the of that The y is not an of tumor therapy of r indicates a tumor when a documented a the at remaining in a patient therapy with (eg, surgical resection for is by a system as shown of tumor be No the the classification may be useful to indicate the or of the of a surgical For the pathologist, the classification is relevant to the of the margins of a surgical resection is, tumor involving the resection on pathologic may be to to tumor in the patient and may be as or microscopic to the at the specimen invasion indicates whether invasion is in the pathology report. or does not the extent of tumor, unless in the of a

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