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Long NameStaging, Prostate NCI Standard Template
DefinitionThe collection of CDEs used in the prostate staging module based on AJCC Edition 7.
ContextcaBIG
Protocol Long NameNCI Standard Template Forms
WorkflowRELEASED
TypeCRF
Public ID3443682
Version2.0
Module Long NameModule InstructionsQuestionCDECDE Public IDCDE VersionValue Domain Data TypeValue Domain Unit of MeasureDisplay FormatValid ValueForm Value Meaning TextForm Value Meaning Desc.
Mandatory Prostate Staging QuestionsThese items must be included when this data is collected for reporting.
Date Current Staging Assessment CompletedCurrent Stage Complete Assessment Date627393.0DATEMM/DD/YYYY
Conditional Prostate Staging QuestionsThere are business rules to indicate situations under which this element should be used on a case report form.
Clinical T StageProstate Cancer American Joint Committee on Cancer (AJCC) Edition 7 Clinical Tumor T Stage34365561.0CHARACTER
TXProstate Cancer cTX TNM Finding v7Primary tumor cannot be assessed. (from AJCC 7th Ed.)
T0Prostate Cancer cT0 TNM Finding v7No evidence of primary tumor. (from AJCC 7th Ed.)
T1Prostate Cancer cT1 TNM Finding v7Clinically inapparent tumor neither palpable nor visible by imaging. (from AJCC 7th Ed.)
T1aProstate Cancer cT1a TNM Finding v7Tumor incidental histologic finding in 5% or less of tissue resected. (from AJCC 7th Ed.)
T1bProstate Cancer cT1b TNM Finding v7Tumor incidental histologic finding in more than 5% of tissue resected. (from AJCC 7th Ed.)
T1cProstate Cancer cT1c TNM Finding v7Tumor identified by needle biopsy (e.g., because of elevated PSA). (from AJCC 7th Ed.)
T2Prostate Cancer cT2 TNM Finding v7Prostate cancer confined within the prostate. Tumor found in one or both lobes by needle biopsy, but not palpable or reliably visible by imaging, is classified as T1c. (from AJCC 7th Ed.)
T2aProstate Cancer cT2a TNM Finding v7Prostate cancer with tumor involving one-half of one lobe or less. (from AJCC 7th Ed.)
T2bProstate Cancer cT2b TNM Finding v7Prostate cancer with tumor involving more than one-half of one lobe, but not both lobes. (from AJCC 7th Ed.)
T2cProstate Cancer cT2c TNM Finding v7Prostate cancer with tumor involving both lobes. (from AJCC 7th Ed.)
T3Prostate Cancer cT3 TNM Finding v7Prostate cancer extending through the prostatic capsule. Invasion into the prostatic apex or into (but not beyond) the prostatic capsule is classified not as T3 but as T2. (from AJCC 7th Ed.)
T3aProstate Cancer cT3a TNM Finding v7Prostate cancer with extracapsular extension (unilateral or bilateral). (from AJCC 7th Ed.)
T3bProstate Cancer cT3b TNM Finding v7Prostate cancer invading seminal vesicle(s). (from AJCC 7th Ed.)
T4Prostate Cancer cT4 TNM Finding v7Prostate cancer with fixed tumor or tumor invading adjacent structures other than seminal vesicles such as external sphincter, rectum, bladder, levator muscles, and/or pelvic wall. (from AJCC 7th Ed.)
Clinical N StageProstate Cancer American Joint Committee on Cancer (AJCC) Edition 7 Clinical Regional Lymph Node N Stage34365611.0CHARACTER
N0Prostate Cancer cN0 TNM Finding v7Prostate cancer with no regional lymph node metastasis. (from AJCC 7th Ed.)
N1Prostate Cancer cN1 TNM Finding v7Prostate cancer with metastasis in regional lymph node(s). (from AJCC 7th Ed.)
NXProstate Cancer cNX TNM Finding v7Prostate cancer in which the regional lymph nodes cannot be assessed. (from AJCC 7th Ed.)
Clinical M StageProstate Cancer American Joint Committee on Cancer (AJCC) Edition 7 Clinical Distant Metastasis M Stage34365621.0CHARACTER
M0Prostate Cancer cM0 TNM Finding v7Prostate cancer without evidence of distant metastasis. (from AJCC 7th Ed.)
M1Prostate Cancer cM1 TNM Finding v7Prostate cancer with distant metastasis. (from AJCC 7th Ed.)
M1aProstate Cancer cM1a TNM Finding v7Prostate cancer with metastasis to non-regional lymph node(s). (from AJCC 7th Ed.)
M1bProstate Cancer cM1b TNM Finding v7Prostate cancer with metastasis to bone(s). (from AJCC 7th Ed.)
M1cProstate Cancer cM1c TNM Finding v7Prostate cancer with metastasis to other site(s) with or without bone disease. (from AJCC 7th Ed.)
Pathologic T StageProstate Cancer American Joint Committee on Cancer (AJCC) Edition 7 Pathologic Tumor T Stage34365632.0CHARACTER
TXProstate Cancer cTX TNM Finding v7Primary tumor cannot be assessed. (from AJCC 7th Ed.)
T0Prostate Cancer cT0 TNM Finding v7No evidence of primary tumor. (from AJCC 7th Ed.)
pT2Prostate Cancer pT2 TNM FindingProstate cancer confined to the prostate gland. (from AJCC 6th Ed.)
pT2aProstate Cancer pT2a TNM FindingProstate cancer limited to one-half or less of one lobe of the prostate gland. (from AJCC 6th Ed.)
pT2bProstate Cancer pT2b TNM FindingProstate cancer involving more than one-half of one lobe, but not both lobes of the prostate gland. (from AJCC 6th Ed.)
pT2cProstate Cancer pT2c TNM FindingProstate cancer involving both lobes of the prostate gland. (from AJCC 6th Ed.)
pT3Prostate Cancer pT3 TNM FindingProstate cancer with extraprostatic extension. (from AJCC 6th and 7th Eds.)
pT3aProstate Cancer pT3a TNM Finding v7Prostate cancer with extraprostatic extension or microscopic invasion of bladder neck. Positive surgical margin should be indicated by an R1 descriptor (residual microscopic disease). (from AJCC 7th Ed.)
pT3bProstate Cancer pT3b TNM FindingProstate cancer extending beyond the capsule of the prostate gland, with involvement of the seminal vesicles. (from AJCC 6th Ed.)
pT4Prostate Cancer pT4 TNM Finding v7Prostate cancer with tumor invading the rectum, levator muscles, and/or pelvic wall. (from AJCC 7th Ed.)
Pathologic N StageProstate Cancer American Joint Committee on Cancer (AJCC) Edition 7 Pathologic Regional Lymph Node N Stage34365642.0CHARACTER
NXProstate Cancer pNX TNM FindingProstate cancer in which the regional lymph nodes were not sampled. (from AJCC 6th and 7th Eds.)
pN0Prostate Cancer pN0 TNM FindingProstate cancer with no positive regional nodes. (from AJCC 6th and 7th Eds.)
pN1Prostate Cancer pN1 TNM FindingProstate cancer with involvement of regional lymph nodes. (from AJCC 6th Ed.)
Pathologic M StageProstate Cancer American Joint Committee on Cancer (AJCC) Edition 7 Pathologic Distant Metastasis M Stage34365651.0CHARACTER
M1Prostate Cancer pM1 TNM FindingProstate cancer with metastasis to one or more distant sites. (from AJCC 6th Ed.)
M1aProstate Cancer pM1a TNM FindingProstate cancer with metastasis to non-regional lymph nodes. (from AJCC 6th Ed.)
M1bProstate Cancer pM1b TNM FindingProstate cancer with metastasis to bone. (from AJCC 6th Ed.)
M1cProstate Cancer pM1c TNM FindingProstate cancer with metastasis to distant sites other than bone and/or non-regional lymph nodes. (from AJCC 6th Ed.)
Disease StageProstate Cancer American Joint Committee on Cancer (AJCC) Edition 7 Group Stage34365661.0CHARACTER
IStage I Prostate CancerStage I includes: (T1a-c, N0, M0, PSA less than 10, Gleason equal or less than 6); (T2a, N0, M0, PSA less than 10, Gleason equal or less than 6); (T1-2a, N0, M0, PSA X, Gleason X). 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). T2a: Tumor involves one-half of one lobe or less. cN0: No regional lymph node metastasis. pN0: No positive regional nodes. M0: No distant metastasis. Gleason Equal or Less than 6: Well differentiated (slight anaplasia). Gleason X: Gleason score cannot be processed. (AJCC 7th ed.)
IIAStage IIA Prostate CancerStage IIA includes: (T1a-c, N0, M0, PSA less than 20, Gleason 7); (T1a-c, N0, M0, PSA equal or more than 10 and less than 20, Gleason equal or less than 6); (T2a, N0, M0, PSA less than 20, Gleason equal or less than 7); (T2b, N0, M0, PSA less than 20, Gleason equal or less than 7); (T2b, N0, M0, PSA X, Gleason X). 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). T2a: Tumor involves one-half of one lobe or less. T2b: Tumor involves more than one-half of one lobe, but not both lobes. cN0: No regional lymph node metastasis. pN0: No positive regional nodes. M0: No distant metastasis. Gleason 7: Moderately differentiated (moderate anaplasia). Gleason Equal or Less than 6: Well differentiated (slight anaplasia). (AJCC 7th ed.)
IIBStage IIB Prostate CancerStage IIB includes: (T2c, N0, M0, Any PSA, Any Gleason); (T1-2, N0, M0, PSA equal or more than 20, Any Gleason); (T1-2, N0, M0, Any PSA, Gleason equal or more than 8). T2c: Tumor involves both lobes. 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). T2a: Tumor involves one-half of one lobe or less. T2b: Tumor involves more than one-half of one lobe, but not both lobes. cN0: No regional lymph node metastasis. pN0: No positive regional nodes. M0: No distant metastasis. Gleason equal or more than 8: Poorly differentiated/undifferentiated (marked anaplasia). (AJCC 7th ed.)
IIIStage III Prostate CancerStage III includes: T3a-b, N0, M0, Any PSA, Any Gleason. cT3a: Tumor with extracapsular extension (unilateral or bilateral). pT3a: Tumor with extraprostatic extension or microscopic invasion of bladder neck. T3b: Tumor invades seminal vesicle(s). cN0: No regional lymph node metastasis. pN0: No positive regional nodes. M0: No distant metastasis. (AJCC 7th ed.)
IVStage IV Prostate CancerStage IV includes: (T4, N0, M0, Any PSA, Any Gleason); (Any T, N1, M0, Any PSA, Any Gleason); (Any T, Any N, M1, Any PSA, Any Gleason). cT4: Tumor is fixed or invades adjacent structures other than seminal vesicles such as external sphincter, rectum, bladder, levator muscles, and/or pelvic wall. pT4: Invasion of rectum, levator muscles, and/or pelvic wall. N1: Metastasis in regional lymph node(s). M1: Distant metastasis. (AJCC 7th ed.)
Stage unknownStage UnknownA finding indicating that the extent of organ/tissue involvement by a malignant neoplasm is not reported or not assessed.
Jewett StageProstate Carcinoma Whitmore-Jewett System Stage29023781.0CHARACTER
ATumor is present, but not detectable clinically; found incidentallyTumor is present, but not detectable clinically; found incidentally
A1Tissue resembles normal cells; found in a chips from one lobeTissue resembles normal cells; found in a chips from one lobe
A2More extensive involvement (than A1 stage)More extensive involvement (than A1 stage)
BTumor can be felt on physical examination, but has not spread outside the prostatic capsuleTumor can be felt on physical examination, but has not spread outside the prostatic capsule
B1Tumor can be felt and does not occupy a whole lobeTumor can be felt and does not occupy a whole lobe
B2Tumor can be felt and it occupies a whole lobe or both lobesTumor can be felt and it occupies a whole lobe or both lobes
BINTumor can be felt, it does not occupy a whole lobe, and is surrounded by normal tissueTumor can be felt, it does not occupy a whole lobe, and is surrounded by normal tissue
CTumor has extended through the capsuleTumor has extended through the capsule
C1Tumor has extended through the capsule but does not involve the seminal vesiclesTumor has extended through the capsule but does not involve the seminal vesicles
C2Tumor involves the seminal vesiclesTumor involves the seminal vesicles
DTumor has spread to other organsTumor has spread to other organs
Optional Prostate Staging QuestionsThere is no requirement for inclusion of these elements on the case report form. If the design and scientific questions posed in the study dictate the need to collect this type of data, these elements should be included.
Staging Time PointDisease Staging Timepoint Name28473521.0CHARACTER
Current DiagnosisCurrent DiagnosisOccurring in or belonging to the present time.: The investigation, analysis and recognition of the presence and nature of disease, condition, or injury from expressed signs and symptoms; also, the scientific determination of any kind; the concise results of such an investigation.
Initial DiagnosisFirst DiagnosisPreceding all others in time or space or degree.: The investigation, analysis and recognition of the presence and nature of disease, condition, or injury from expressed signs and symptoms; also, the scientific determination of any kind; the concise results of such an investigation.
RestagingRestagingRepeat of staging assessment
Study EnrollmentClinical Study EnrollmentResearch conducted with human subjects or on material of human origin in which an investigator directly interacts with human subjects; includes development of new technologies, mechanism of human diseases, therapy, clinical trials, epidemiology, behavior and health services research. : Enrollment; to insert, register, or enter in a list, catalog, or roll. (Merriam-Webster Online)