Form:Prostate Reference Set v1.0


CDE IDCDE Description
* 1063Site Participant ID (Go To: 1319)
* 422EDRN Site ID (Go To: 423)
   423EDRN Protocol ID (Go To: 1319)
* 1319Date participant signed consent form (MM/DD/YYYY): (Go To: 1292)
   1292Height [in inches] (What is your total current height in inches?) (Go To: 1295)
   1295Weight [in pounds] (What is your current weight [in pounds]? (Go To: 1322)
   1322Hispanic or Latino (Are you Hispanic or Latino?) (Go To: 1315)
 
Permissible Values (value):No (0)
 
 Yes (1)
 
 Unknown/refused (9)
   1315Race (What is your race? Check all that apply.) (Go To: 1567)
 
Permissible Values (value):White (1)
 
 Black or African-American (2)
 
 American Indian or Alaska Native (3)
 
 Asian (4)
 
 Native Hawaiian or other Pacific Islander (7)
 
 Other, specify: (97) (Go To: 1294)
 
 Unknown/refused (99)
   1294Race (Other, specify) (Go To: 1567)
   1567Which race do you consider to be your primary racial background? (Go To: 578)
 
Permissible Values (value):White (1)
 
 Black or African-American (2)
 
 American Indian or Alaska Native (3)
 
 Asian (4)
 
 Native Hawaiian or other Pacific Islander (7)
 
 Other, specify: (97) (Go To: 1579)
 
 Unknown/refused (99)
   1579Primary racial background (Other, specify) (Go To: 578)
   578Age at specimen collection (Go To: 1300)
   1300Ever smoke cigarettes regularly, at least one a day for a year or more? (Did you ever smoke cigarettes regularly, at least one a day for a year or more?) (Go To: 1568)
 
Permissible Values (value):No (0)
 
 Yes (1) (Go To: 1299)
 
 Unknown/refused (9)
   1299Currently smoke at least one cigarette a day? (Do you currently smoke cigarettes regularly, at least one a day?) (Go To: 1297)
 
Permissible Values (value):No (0) (Go To: 1298)
 
 Yes (1)
 
 Unknown/refused (9)
   1298Age quit smoking cigarettes? (How old were you when you permanently quit smoking cigarettes?) (Go To: 1297)
   1297Age first began smoking cigarettes regularly, at least one a day? (How old were you when you began smoking cigarettes regularly, at least one a day?) (Go To: 1325)
   1325Average number of cigarettes smoked per day? (During the time you have smoked, on average, how many cigarettes did you smoke per day?) (Go To: 1568)
   1568Have any of the participants living or deceased first or second-degree blood relatives been diagnosed with prostate cancer? (Go To: 1070)
 
Permissible Values (value):No (0)
 
 Yes (1) (Go To: 1569)
 
 Unknown/refused (9)
   1569How many of the participant´s living or deceased first or second-degree blood relatives have been diagnosed with prostate cancer? (Go To: 1570)
   1570How many of the participant´s living or deceased first or second-degree blood relatives have died of prostate cancer? (Go To: 1070)
   1070Have you ever been told by a doctor that you have any of the following genitourinary conditions? (Check all that apply.) (Go To: 1571)
 
Permissible Values (value):[Males only] BPH (Benign prostatic hypertrophy) (1)
 
 Hematuria (blood in the urine) (2)
 
 [Males only] Prostatitis (an inflamed prostate) (3)
 
 Urethritis (inflammation of the urethra) (6)
 
 Other type of genitourinary tract infection (7)
 
 None (44)
   1571Have you ever had any of the following procedures or problems? (Check all that apply.) (Go To: 1576)
 
Permissible Values (value):[Males only] Transurethral resection of the prostate (TURP) (1)
 
 [Males only] Transurethral incision of the prostate (TUIP) (2)
 
 [Males only] Laser treatment for the prostate (interstitial laser or Niagra PVP) (3)
 
 [Males only] Microwave or heat treatment for the prostate (TUNA or TUMT) (4)
 
 [Males only] Balloon dilation (5)
 
 None (44)
   1576American Urological Association (AUA) symptom score: (Go To: 1691)
   1691Quality of life due to urinary symptoms: (Go To: 1572)
 
Permissible Values (value):Delighted (1)
 
 Pleased (2)
 
 Mostly satisfied (3)
 
 Mixed (4)
 
 Mostly dissatisfied (5)
 
 Unhappy (6)
 
 Terrible (7)
   1572Have you ever taken any of the following medications or supplements for a prostate or genitourinary condition? (Check all that apply.) (Go To: 1574)
 
Permissible Values (value):5-alpha reductase inhibitors (eg Finasteride, Avodart or Proscar) (1)
 
 Alpha-blockers (eg Doxazoin, Terazosin, Tamsulosin, others) (2)
 
 Anti-cholinergics (3)
 
 Androgens (eg Testosterone, Androgel, others) (4)
 
 Saw Palmetto (5)
 
 None (44) (Go To: 1318)
 
 Other medications for prostate related conditions, specify: (97) (Go To: 1573)
   1573Other prostate or genitourinary medications, specify: (Go To: 1574)
   1574When were the medications or supplements for your prostate or genitourinary condition last taken? (Go To: 1575)
 
Permissible Values (value):Within the past month (1)
 
 More than 1 month ago (2)
   1575Total number of months taken (Go To: 1318)
   1318Previous prostate biopsy? (Go To: 1699)
 
Permissible Values (value):No (0)
 
 Yes (1) (Go To: 1698)
 
 Unknown/refused (9)
   1698How many prostate biopsies have you previously had? (Go To: 1699)
   1699Date of current prostate biopsy (MM/DD/YYYY): (Go To: 1577)
   1577Indication for current prostate biopsy (Check all that apply.) (Go To: 979)
 
Permissible Values (value):Rising PSA (1)
 
 Elevated PSA (2)
 
 Abnormal DRE (3)
 
 Abnormal biopsy (4)
 
 Atypia (5)
 
 Atypical small acinar proliferation (ASAP) (6)
 
 Family history (7)
 
 High grade PIN (8)
 
 Other, specify: (97) (Go To: 1578)
   1578Indication for prostate biopsy, other specify: (Go To: 979)
   979Date of digital rectal exam (DRE) (MM/DD/YYYY): (Go To: 976)
   976Digital rectal exam results: (Go To: 1580)
 
Permissible Values (value):Normal (1)
 
 Enlarged, benign (3)
 
 Enlarged/Asymmetry (4)
 
 Abnormal (firm/induration/nodularity), suspicious for cancer (5)
 
 Unknown/refused (99)
   1580Amount of induration/nodularity on digital rectal exam (DRE), if not normal: (Go To: 1582)
 
Permissible Values (value):< 50% right (1)
 
 ≥ 50% right (2)
 
 < 50% left (3)
 
 ≥ 50% left (4)
 
 Bilateral (5)
 
 Abnormal DRE but extent not specified (6)
   1582Date of PSA: (Go To: 947)
   947PSA (ng/ml) (Go To: 1692)
   1692Prostate size (by TRUS): (Go To: 1581)
   1581Hypoechoic or suspicious foci seen? (Go To: 1583)
 
Permissible Values (value):No (0)
 
 Yes (1)
   1583Number of cores biopsied on left: (Go To: 1584)
   1584Number of cores biopsied on right: (Go To: 1693)
   1693Number of other cores biopsied: (Go To: 1585)
   1585Types of other cores biopsied, specify: (Go To: 1586)
   1586Presence of prostate adenocarcinoma: (Go To: 984)
 
Permissible Values (value):Malignancy absent (1)
 
 Malignancy present (2) (Go To: 1587)
   1587Number of positive cores involved on left: (Go To: 1588)
   1588Number of positive cores involved on right: (Go To: 1589)
   1589Primary Gleason grade: (Go To: 1590)
   1590Secondary Gleason grade: (Go To: 1696)
   1696Tertiary Gleason Pattern: (Go To: 1697)
   1697Overall Gleason Score: (Go To: 1591)
   1591Perineural invasion: (Go To: 1592)
 
Permissible Values (value):Present (1)
 
 Absent (2)
   1592Percent of cancer in core with most cancer: (Go To: 1593)
   1593Length of core with most cancer (mm): (Go To: 975)
   975Prostate T-Stage, Clinical (Go To: 1594)
 
Permissible Values (value):T0 (2)
 
 T1 (3)
 
 T1a (4)
 
 T1b (5)
 
 T1c (6)
 
 T2 (7)
 
 T2a (8)
 
 T2b (9)
 
 T2c (10)
 
 T3 (11)
 
 T3a (12)
 
 T3b (13)
 
 T4 (14)
 
 TX (15)
   1594Prostate N-Stage, Clinical (Go To: 1694)
 
Permissible Values (value):NX (1)
 
 N0 (2)
 
 N1 (3)
   1694Prostate M-Stage, Clinical : (Go To: 984)
 
Permissible Values (value):MX (1)
 
 M0 (2)
 
 M1 (3)
 
 M1a (4)
 
 M1b (5)
 
 M1c (6)
   984High grade prostatic intraepithelial neoplasia (PIN)? (Go To: 1595)
 
Permissible Values (value):No (0)
 
 Yes (1)
   1595Inflammation present? (Go To: 1596)
 
Permissible Values (value):No (0)
 
 Yes (1)
   1596Atypical small acinar proliferation (ASAP)? (Go To: 1597)
 
Permissible Values (value):No (0)
 
 Yes (1)
   1597Atypia/Suspicious? (Go To: 1598)
 
Permissible Values (value):No (0)
 
 Yes (1)
   1598Atrophy? (Go To: 1599)
 
Permissible Values (value):No (0)
 
 Yes (1)
   1599Was blood collected after the DRE performed on the same day as specimen collection? (Go To: End of Form)
 
Permissible Values (value):No (0)
 
 Yes (1)
 
 Unknown/refused (9)