Adenocarcinoma of prostate
Item
subjects must have biopsy-confirmed adenocarcinoma of the prostate.
boolean
C0007112 (UMLS CUI [1])
Bone scan Negative
Item
subjects must have a negative bone scan.
boolean
C0203668 (UMLS CUI [1,1])
C1513916 (UMLS CUI [1,2])
High risk of Prostate carcinoma
Item
subjects must have "high-risk" prostate cancer, defined as:
boolean
C0332167 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
PSA measurement | Gleason score | TNM clinical staging
Item
a. psa >/= 20, and/or b. gleason score (gs) >/= 8, and/or c. clinical stage t3 disease per ajcc staging manual, 6th edition; or d. at least two out of three of the following: psa 10-19.9, gs = 7, or clinical stage = t2b / t2c.
boolean
C0201544 (UMLS CUI [1])
C3203027 (UMLS CUI [2])
C3258246 (UMLS CUI [3])
Fit Receive Operative Surgical Procedure
Item
subjects must be medically fit to undergo surgery as determined by treating urologist.
boolean
C0424576 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
Age
Item
subjects must be under 70 years of age.
boolean
C0001779 (UMLS CUI [1])
Karnofsky Performance Status
Item
kps must be >/= 80.
boolean
C0206065 (UMLS CUI [1])
Primary tumor Absent | Malignant Neoplasm Free of
Item
subjects must not have a synchronous primary tumor, or a previous cancer unless disease free for >/= 5 years.
boolean
C0677930 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0006826 (UMLS CUI [2,1])
C0332296 (UMLS CUI [2,2])
Radiotherapy to pelvis Absent | Chemotherapy Absent | Antiandrogen therapy Absent
Item
subjects must not have had prior pelvic radiation therapy, chemotherapy, or androgen deprivation.
boolean
C1536155 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0392920 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0279492 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Informed Consent
Item
subjects must freely sign informed consent to enroll in the study.
boolean
C0021430 (UMLS CUI [1])
Neoplasm Metastasis Bone scan | Neoplasm Metastasis CT of Pelvis | Neoplasm Metastasis MRI of Pelvis | Neoplasm Metastasis Chest X-ray
Item
metastatic disease as demonstrated by bone scan, ct scan or mri of the pelvis, or chest x-ray.
boolean
C0027627 (UMLS CUI [1,1])
C0203668 (UMLS CUI [1,2])
C0027627 (UMLS CUI [2,1])
C0412628 (UMLS CUI [2,2])
C0027627 (UMLS CUI [3,1])
C0203201 (UMLS CUI [3,2])
C0027627 (UMLS CUI [4,1])
C0039985 (UMLS CUI [4,2])
Pelvic lymph nodes Positive | CT scan Preoperative Pelvic lymph nodes | MRI Preoperative Pelvic lymph nodes | Biopsy Pelvic lymph nodes
Item
pathologically documented positive pelvic lymph nodes. if pre-operative ct scan or mri (ordered at the discretion of the treating physicians) demonstrates lymph nodes which are suspicious for involvement, then biopsy must be undertaken and nodes proven negative before patient can enroll on this trial.
boolean
C0729595 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C0040405 (UMLS CUI [2,1])
C0445204 (UMLS CUI [2,2])
C0729595 (UMLS CUI [2,3])
C0024485 (UMLS CUI [3,1])
C0445204 (UMLS CUI [3,2])
C0729595 (UMLS CUI [3,3])
C0005558 (UMLS CUI [4,1])
C0729595 (UMLS CUI [4,2])
High risk Anesthesia
Item
declared high-risk for anesthesia by attending anesthesiologist, cardiologist, or other physician.
boolean
C0332167 (UMLS CUI [1,1])
C0002903 (UMLS CUI [1,2])
Radiotherapy to pelvis
Item
history of prior pelvic radiation therapy.
boolean
C1536155 (UMLS CUI [1])
Antiandrogen therapy | Chemotherapy
Item
history of androgen deprivation therapy or chemotherapy.
boolean
C0279492 (UMLS CUI [1])
C0392920 (UMLS CUI [2])