Form:PCA3 Clinical Data v2.0


CDE IDCDE Description
* 421EDRN Participant ID (Go To: 423)
* 423EDRN Protocol ID (Go To: 422)
* 422EDRN Site ID (Go To: 929)
* 929EDRN Staff ID of the person who collected the data: (Go To: 1219)
* 1219Date of contact (MM/DD/YYYY): (Go To: 2651)
* 2651PCA-3 administered for clinical purpose? (Go To: End of Form)
 
Permissible Values (value):No (0)
 
 Yes (1)
 
 Unknown/refused (9)
* 2774Evidence of urinary tract infection? (Go To: 2775)
 
Permissible Values (value):No (0)
 
 Yes, evidence of treated UTI (2)
 
 Yes, evidence of untreated UTI (3)
 
 Unknown (99)
* 2775Cystoscopy performed? (Go To: 2776)
 
Permissible Values (value):No (0)
 
 Yes (1)
 
 Unknown (99)
* 2776Catheter inserted? (Go To: 1318)
 
Permissible Values (value):No (0)
 
 Yes (1)
 
 Unknown (99)
* 1318Previous prostate biopsy? (Go To: 578)
 
Permissible Values (value):No (0)
 
 Yes (1) (Go To: 1698)
 
 Unknown/refused (9)
* 1698How many prostate biopsies have you previously had? (Go To: 2625)
* 2625Date of most recent biopsy (MM/DD/YYYY): (Go To: 2652)
* 2652Saturation biopsy? (Go To: End of Form)
 
Permissible Values (value):No (0)
 
 Yes (1)
 
 Unknown/refused (9)
* 578Age at specimen collection (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: 1576)
* 1576American Urological Association (AUA) symptom score: (Go To: 1691)
* 1691Quality of life due to urinary symptoms: (Go To: 979)
 
Permissible Values (value):Delighted (0)
 
 Pleased (1)
 
 Mostly satisfied (2)
 
 Mixed (3)
 
 Mostly dissatisfied (4)
 
 Unhappy (5)
 
 Terrible (6)
 
 Unknown/refused (99)
* 979Date of digital rectal exam (DRE) (MM/DD/YYYY): (Go To: 976)
* 976Digital rectal exam results: (Go To: 973)
 
Permissible Values (value):Normal (1)
 
 Enlarged, benign (3)
 
 Enlarged/Asymmetry (4)
 
 Abnormal (firm/induration/nodularity), suspicious for cancer (5) (Go To: 2173)
 
 Unknown/refused (99)
   2173Amount of induration/nodularity on digital rectal exam (DRE), if not normal: (Go To: 973)
 
Permissible Values (value):< 50% right (1)
 
 ≥ 50% right (2)
 
 < 50% left (3)
 
 ≥ 50% left (4)
 
 Bilateral (5)
 
 Abnormal DRE but extent not specified (6)
   973Date of prostate biopsy (MM/DD/YYYY): (Go To: 2705)
* 2705Indication for current prostate biopsy (Check all that apply.) (Go To: 2934)
 
Permissible Values (value):Abnormal DRE (3)
 
 PSA >2.0 ng/ml (21)
 
 Elevated PSA velocity (>0.4 ng/ml/yr) (22)
 
 Lower PSA value with other risk factors for PCa (e.g. family history) (23)
 
 Prior ASAP or HGPIN (24)
 
 % free PSA<15% (25)
 
 Other (95)
* 2934Was the biopsy performed? (Go To: 2653)
 
Permissible Values (value):No (0) (Go To: 1097)
 
 Yes (1)
* 2653Extended template biopsy? (Go To: 1581)
 
Permissible Values (value):No (0)
 
 Yes (1)
* 1581Hypoechoic or suspicious foci seen? (Go To: 1692)
 
Permissible Values (value):No (0)
 
 Yes (1)
 
 Unknown (99)
   1692Prostate size (by TRUS): (Go To: 1586)
* 1586Presence of prostate adenocarcinoma: (Go To: 980)
 
Permissible Values (value):Malignancy absent (1)
 
 Malignancy present (2) (Go To: 975)
* 975Prostate T-Stage, Clinical (Go To: 2179)
 
Permissible Values (value):T1 (3)
 
 T1a (4)
 
 T1b (5)
 
 T1c (6)
 
 T2a (8)
 
 T2b (9)
 
 T2c (10)
 
 T3a (12)
 
 T3b (13)
 
 T4 (14)
 
 TX (15)
* 2179Prostate N-Stage, Clinical: (Go To: 1694)
 
Permissible Values (value):NX (1)
 
 N0 (2)
 
 N1 (5)
* 1694Prostate M-Stage, Clinical : (Go To: 980)
 
Permissible Values (value):MX (1)
 
 M0 (2)
 
 M1 (3)
 
 M1a (4)
 
 M1b (5)
 
 M1c (6)
* 980Total number of cores taken: (Go To: 1097)
   1097Comments (do not include any participant identifiers) (Go To: End of Form)