Healthy Volunteers
Item
part 1: healthy volunteers only
boolean
C1708335 (UMLS CUI [1])
Gender | Age
Item
- males ≥ 40 years of age
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Patients Prostate carcinoma
Item
part 2: prostate cancer patients
boolean
C0030705 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
Gender | Age
Item
males ≥ 18 years of age
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Serum Prostate Specific Antigen Increased
Item
serum psa (prostate-specific antigen) value above normal.
boolean
C1883014 (UMLS CUI [1])
Principal diagnosis MRI | Principal diagnosis Carbon-11 Choline PET-CT Scan Positive | Principal diagnosis Fluciclovine F-18 PET/CT scan Positive | Prostate cancer recurrent | Primary malignant neoplasm Histology | Adenocarcinoma Histology
Item
patients had an mri and/or a positive [11c] - or [18f] -choline pet/ct for primary diagnosis (note: mri and [11c]-or [18f]-choline pet/ct are optional for primary prostate cancer patients) or recurrence detection of prostate cancer and the primary cancer disease (adenocarcinoma) is histologically confirmed
boolean
C0332137 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C0332137 (UMLS CUI [2,1])
C2985492 (UMLS CUI [2,2])
C1514241 (UMLS CUI [2,3])
C0332137 (UMLS CUI [3,1])
C1311253 (UMLS CUI [3,2])
C1699633 (UMLS CUI [3,3])
C1514241 (UMLS CUI [3,4])
C0278838 (UMLS CUI [4])
C1306459 (UMLS CUI [5,1])
C0344441 (UMLS CUI [5,2])
C0001418 (UMLS CUI [6,1])
C0344441 (UMLS CUI [6,2])
Patients Prostate carcinoma Primary | Prostatectomy Scheduled
Item
patients with primary prostate cancer have to be scheduled for prostatectomy
boolean
C0030705 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
C0033573 (UMLS CUI [2,1])
C0205539 (UMLS CUI [2,2])
Patients Prostate carcinoma Primary | Adenocarcinoma Gleason score | Biopsy Quantity Prostate Location
Item
in patients with primary prostate cancer, histopathological evaluation has to show an adenocarcinoma with a gleason score of 3 + 3 or higher in at least two biopsies at any location in the prostate
boolean
C0030705 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
C0001418 (UMLS CUI [2,1])
C3203027 (UMLS CUI [2,2])
C0005558 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0033572 (UMLS CUI [3,3])
C1515974 (UMLS CUI [3,4])
Patients Prostate carcinoma Advanced Primary | Patients Prostate cancer recurrent | Probability High Secondary malignant neoplasm of lymph node | Patients Scheduled Pelvic lymphadenectomy
Item
patients with advanced primary or recurrent prostate cancer and a high likelihood to display lymph node metastasis, ideally scheduled for explorative pelvic lymphadenectomy, are to be preferably included
boolean
C0030705 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
C0205179 (UMLS CUI [1,3])
C0205225 (UMLS CUI [1,4])
C0030705 (UMLS CUI [2,1])
C0278838 (UMLS CUI [2,2])
C0033204 (UMLS CUI [3,1])
C0205250 (UMLS CUI [3,2])
C0686619 (UMLS CUI [3,3])
C0030705 (UMLS CUI [4,1])
C0205539 (UMLS CUI [4,2])
C0193883 (UMLS CUI [4,3])
Patients Prostate carcinoma | Probability High Neoplasm Metastasis | Probability High Secondary malignant neoplasm of lymph node
Item
part 3: prostate cancer patients -- the criteria for eligibility of part 3 are identical to the ones of part 2. except it is now no longer a preference but mandatory to only enrol patients with a presumably high likelihood of metastatic disease, especially lymph node metastasis.
boolean
C0030705 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
C0033204 (UMLS CUI [2,1])
C0205250 (UMLS CUI [2,2])
C0027627 (UMLS CUI [2,3])
C0033204 (UMLS CUI [3,1])
C0205250 (UMLS CUI [3,2])
C0686619 (UMLS CUI [3,3])
Comorbidity Severe | Comorbidity Uncontrolled | Comorbidity Unstable | Exception Prostate carcinoma | Poorly controlled diabetes mellitus | Congestive heart failure | Myocardial Infarction | BAY 1075553 Injection Planned | Hypertensive disease Unstable | Uncontrolled hypertension | Chronic Kidney Disease | Chronic liver disease | Lung disease Severe | Comorbidity compromises Study Subject Participation Status
Item
concurrent severe and/or uncontrolled and/or unstable medical disease other than prostate cancer (e.g. poorly controlled diabetes, congestive heart failure, myocardial infarction within 12 months prior to planned injection of bay1075553, unstable and uncontrolled hypertension, chronic renal or hepatic disease, severe pulmonary disease) which could compromise participation in the study
boolean
C0009488 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0009488 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0009488 (UMLS CUI [3,1])
C0443343 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0600139 (UMLS CUI [4,2])
C0554876 (UMLS CUI [5])
C0018802 (UMLS CUI [6])
C0027051 (UMLS CUI [7])
C3852872 (UMLS CUI [8,1])
C1533685 (UMLS CUI [8,2])
C1301732 (UMLS CUI [8,3])
C0020538 (UMLS CUI [9,1])
C0443343 (UMLS CUI [9,2])
C1868885 (UMLS CUI [10])
C1561643 (UMLS CUI [11])
C0341439 (UMLS CUI [12])
C0024115 (UMLS CUI [13,1])
C0205082 (UMLS CUI [13,2])
C0009488 (UMLS CUI [14,1])
C2945640 (UMLS CUI [14,2])
C2348568 (UMLS CUI [14,3])
Renal Insufficiency | Etiology Hepatorenal Syndrome | Perioperative Period Transplantation of liver
Item
acute renal insufficiency of any intensity, either due to hepato-renal syndrome or occurring in the peri-operative liver transplantation period
boolean
C1565489 (UMLS CUI [1])
C0015127 (UMLS CUI [2,1])
C0019212 (UMLS CUI [2,2])
C2712230 (UMLS CUI [3,1])
C0023911 (UMLS CUI [3,2])
Inflammatory Bowel Disease
Item
active inflammatory bowel disease within the last 6 months
boolean
C0021390 (UMLS CUI [1])
Prostatitis Treatment required for
Item
acute prostatitis requiring medical treatment within the last 6 months
boolean
C0033581 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
Bacterial Infection | Exception Urological system | Requirement Antibiotic therapy
Item
a non-urologic bacterial infection requiring active treatment with antibiotics within 3 months
boolean
C0004623 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699869 (UMLS CUI [2,2])
C1514873 (UMLS CUI [3,1])
C0338237 (UMLS CUI [3,2])
Cancer Other | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin
Item
active other malignancy (except basal cell or squamous cell skin cancer) within the last 2 years
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
Patients Prostate carcinoma Primary | Androgen suppression
Item
patients with primary prostate cancer only: androgen ablation within 3 months before planned treatment
boolean
C0030705 (UMLS CUI [1,1])
C0600139 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
C1515985 (UMLS CUI [2])
Criteria Study Subject Participation Status Excluded | Etiology Scientific | Etiology Compliance behavior | Etiology Patient safety
Item
subject fulfils criteria which in the opinion of the investigator preclude participation for scientific reasons, for reasons of compliance, or for reasons of the subject's safety
boolean
C0243161 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C0015127 (UMLS CUI [2,1])
C0036397 (UMLS CUI [2,2])
C0015127 (UMLS CUI [3,1])
C1321605 (UMLS CUI [3,2])
C0015127 (UMLS CUI [4,1])
C1113679 (UMLS CUI [4,2])