Adenocarcinoma of prostate | Core needle biopsy of prostate Quantity Minimum
Item
1. histologically identified adenocarcinoma of the prostate by minimum 6 core prostate biopsy.
boolean
C0007112 (UMLS CUI [1])
C0194806 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1524031 (UMLS CUI [2,3])
Prostate specific antigen measurement | Status pre- Biopsy of prostate
Item
2. serum psa </= 10 ng/ml before prostate biopsy
boolean
C0201544 (UMLS CUI [1])
C0332152 (UMLS CUI [2,1])
C0194804 (UMLS CUI [2,2])
Specimen from prostate Percentage Positive Prostate carcinoma
Item
3. less than 50% of samples from one side of the prostate positive for prostate cancer.
boolean
C0586596 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C1514241 (UMLS CUI [1,3])
C0600139 (UMLS CUI [1,4])
Core Length Involvement with Prostate carcinoma
Item
4. no greater than 50% of a single core total length occupied by prostate cancer.
boolean
C0444669 (UMLS CUI [1,1])
C1444754 (UMLS CUI [1,2])
C1314939 (UMLS CUI [1,3])
C0600139 (UMLS CUI [1,4])
Gleason Grading System
Item
5. no dominant gleason 4 component. (e.g.; 4+x is not allowed, but x+4 is eligible)
boolean
C0332326 (UMLS CUI [1])
Gleason Grading System | Primary Gleason pattern | Secondary Gleason pattern | Tertiary Gleason pattern
Item
6. no gleason 5 component (primary, secondary or tertiary).
boolean
C0332326 (UMLS CUI [1])
C1273604 (UMLS CUI [2])
C1273605 (UMLS CUI [3])
C1273608 (UMLS CUI [4])
Core Prostate biopsy Contralateral Positive | Core Involvement Length | Gleason pattern Number Absent
Item
7. subjects may have contralateral positive prostate biopsy in a single core within the eligibility biopsy so long as the involvement of this core is 2mm or less and no gleason 4 or gleason 5 pattern exists. this is considered to be non-dominant (contralateral) tumor burden and is not exclusionary.
boolean
C0444669 (UMLS CUI [1,1])
C0194804 (UMLS CUI [1,2])
C0441988 (UMLS CUI [1,3])
C1514241 (UMLS CUI [1,4])
C0444669 (UMLS CUI [2,1])
C1314939 (UMLS CUI [2,2])
C1444754 (UMLS CUI [2,3])
C1273606 (UMLS CUI [3,1])
C0237753 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Biopsy Tumor tissue sample failed | Therapeutic procedure Continued
Item
8. in the case that the confirmatory biopsy fails to sample the tumor again, patients will be allowed to continue into the therapeutic phase using the laterality information obtained during the eligibility biopsy.
boolean
C0005558 (UMLS CUI [1,1])
C0475358 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
C0087111 (UMLS CUI [2,1])
C0549178 (UMLS CUI [2,2])
Medical History Risk Preoperative | Comorbidity Risk Preoperative | Medical History Therapeutic procedure Inappropriate | Comorbidity Therapeutic procedure Inappropriate | Protocol Compliance Unwilling | Protocol Compliance Unable
Item
1. medical history or concurrent disease which in the investigators mind places the patient at significant preoperative risk or for which the investigator does not feel this therapy is appropriate. investigator believes subject is unwilling or unable to comply with study protocol requirements.
boolean
C0262926 (UMLS CUI [1,1])
C0035647 (UMLS CUI [1,2])
C0445204 (UMLS CUI [1,3])
C0009488 (UMLS CUI [2,1])
C0035647 (UMLS CUI [2,2])
C0445204 (UMLS CUI [2,3])
C0262926 (UMLS CUI [3,1])
C0087111 (UMLS CUI [3,2])
C1548788 (UMLS CUI [3,3])
C0009488 (UMLS CUI [4,1])
C0087111 (UMLS CUI [4,2])
C1548788 (UMLS CUI [4,3])
C0525058 (UMLS CUI [5,1])
C0558080 (UMLS CUI [5,2])
C0525058 (UMLS CUI [6,1])
C1299582 (UMLS CUI [6,2])
Symptom score [AUASI]
Item
2. auasi (american urologic association symptom index) score >/=20
boolean
C4265843 (UMLS CUI [1])
Urinary tract infection
Item
3. active urinary tract infection
boolean
C0042029 (UMLS CUI [1])
Anticoagulant therapy | Antiplatelet therapy | Anticoagulants Discontinue Unsuccessful | Antiplatelet Agents Discontinue Unsuccessful | Biopsy of prostate | Cold Therapy
Item
4. active treatment with anticoagulant/anti-platelet agent that cannot be safely stopped at the time of prostate biopsy and cryotherapy.
boolean
C0150457 (UMLS CUI [1])
C1096021 (UMLS CUI [2])
C0003280 (UMLS CUI [3,1])
C1444662 (UMLS CUI [3,2])
C1272705 (UMLS CUI [3,3])
C0085826 (UMLS CUI [4,1])
C1444662 (UMLS CUI [4,2])
C1272705 (UMLS CUI [4,3])
C0194804 (UMLS CUI [5])
C0010412 (UMLS CUI [6])
Medical Castration Initiation Before Biopsy | Male Castration Initiation Before Biopsy | Medical Castration Initiation Post Biopsy | Male Castration Initiation Post Biopsy
Item
5. medical or surgical castration initiated before or after the eligibility biopsy.
boolean
C1513054 (UMLS CUI [1,1])
C1704686 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0005558 (UMLS CUI [1,4])
C0007347 (UMLS CUI [2,1])
C1704686 (UMLS CUI [2,2])
C0332152 (UMLS CUI [2,3])
C0005558 (UMLS CUI [2,4])
C1513054 (UMLS CUI [3,1])
C1704686 (UMLS CUI [3,2])
C0687676 (UMLS CUI [3,3])
C0005558 (UMLS CUI [3,4])
C0007347 (UMLS CUI [4,1])
C1704686 (UMLS CUI [4,2])
C0687676 (UMLS CUI [4,3])
C0005558 (UMLS CUI [4,4])
Informed Consent Unable
Item
6. patient is unable to provide informed consent.
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Bone scan Before Cryosurgery | Neoplasm Metastasis Bone scintigraphy
Item
7. patients will undergo base line bone scan prior to cryoablation to evaluate for regions of abnormal uptake before therapeutic intervention. metastatic disease by bone scintigraphy is exclusionary. bone scans performed within 12 months prior to study entry will be used for study base line purposes and will not need to be repeated, unless clinically indicated.
boolean
C0203668 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0010408 (UMLS CUI [1,3])
C0027627 (UMLS CUI [2,1])
C3889015 (UMLS CUI [2,2])