Adenocarcinoma of prostate | Radical prostatectomy
Item
1. diagnosis of prostate adenocarcinoma on a radical prostatectomy.
boolean
C0007112 (UMLS CUI [1])
C0194810 (UMLS CUI [2])
Radical prostatectomy Previous | Raised prostate specific antigen
Item
2. prior radical prostatectomy within less than 2 years from the time of first psa rise.
boolean
C0194810 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0178415 (UMLS CUI [2])
Biochemical recurrence | Prostate specific antigen measurement Post Radical prostatectomy | Tests Additional Quantity
Item
3. demonstration of biochemical recurrence based on a psa detectable >0.03 less than 24 months after radical prostatectomy and confirmed on 2 additional tests.
boolean
C2985506 (UMLS CUI [1])
C0201544 (UMLS CUI [2,1])
C0687676 (UMLS CUI [2,2])
C0194810 (UMLS CUI [2,3])
C0022885 (UMLS CUI [3,1])
C1524062 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
Prostate-Specific Antigen Doubling Time | Prostate specific antigen measurement
Item
4. psa doubling time over three values must be <= 9 months for psa >=0.4 and psa <=10. if psa is >10, there is no need for psa doubling time.
boolean
C0138741 (UMLS CUI [1,1])
C2986483 (UMLS CUI [1,2])
C0201544 (UMLS CUI [2])
Karnofsky Performance Status
Item
5. karnofsky performance status (kps) >=70%
boolean
C0206065 (UMLS CUI [1])
Organ function | Hemogram | Hemoglobin measurement | Platelet Count measurement | White Blood Cell Count procedure | Creatinine clearance measurement | Liver function tests normal
Item
6. adequate organ function as defined by hemogram with haemoglobin >8.0, platelet >100 000, white blood cell >3,500, creatinine clearance >=60 cc/min and normal liver function tests.
boolean
C0678852 (UMLS CUI [1])
C0200631 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
C0032181 (UMLS CUI [4])
C0023508 (UMLS CUI [5])
C0373595 (UMLS CUI [6])
C0438235 (UMLS CUI [7])
Hormone Therapy Neoadjuvant prior to Radical prostatectomy
Item
7. neoadjuvant hormone therapy prior to radical prostatectomy is allowed provided that the total duration of therapy did not exceed 6 months.
boolean
C0279025 (UMLS CUI [1,1])
C0600558 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C0194810 (UMLS CUI [1,4])
Informed Consent
Item
8. subjects must have signed an informed consent document stating that they understand the investigational or nature of the proposed treatment.
boolean
C0021430 (UMLS CUI [1])
Protocol Compliance
Item
9. subjects must be willing and able to comply with scheduled visits, treatment plans, laboratory tests and other procedures.
boolean
C0525058 (UMLS CUI [1])
Heart Disease New York Heart Association Classification | Lung disease Debilitation Severe
Item
1. clinical significant cardiac disease (new york heart association class iii/iv), or severe debilitating pulmonary disease.
boolean
C0018799 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0024115 (UMLS CUI [2,1])
C0742985 (UMLS CUI [2,2])
C0205082 (UMLS CUI [2,3])
Communicable Disease Serious Uncontrolled
Item
2. uncontrolled serious active infection.
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
Life Expectancy
Item
3. anticipated duration of life less than 2 years.
boolean
C0023671 (UMLS CUI [1])
Successful treatment Cancer Other | Cancer Other Except Prostate carcinoma | Exception Skin carcinoma | Exception Superficial bladder cancer
Item
4. less than 5-year history of successful treatment for other cancers or concurrent active non prostate cancer other than non melanoma dermatologic tumors and non-muscle invasive bladder tumors.
boolean
C0521982 (UMLS CUI [1,1])
C1707251 (UMLS CUI [1,2])
C1707251 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C0600139 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0699893 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C1336527 (UMLS CUI [4,2])
Peripheral Neuropathy CTCAE Grades
Item
5. peripheral neuropathy >=2 grade 2
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Therapies, Investigational | Involvement with Clinical Trials | Involvement with Pharmaceutical Preparations
Item
6. concurrent experimental treatment or involvement in other clinical trials involving drugs.
boolean
C0949266 (UMLS CUI [1])
C1314939 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
C1314939 (UMLS CUI [3,1])
C0013227 (UMLS CUI [3,2])
Medical condition Severe Requirement Investigation | Medical condition chronic Requirement Investigation | Mental disorders Requirement Investigation | Laboratory test result abnormal Requirement Investigation | Investigation At risk Patient safety
Item
7. other severe acute or chronic medical conditions including psychiatric diseases or significant laboratory abnormality requiring further investigation that may cause undue risk for the subject's safety.
boolean
C3843040 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
C0683933 (UMLS CUI [1,4])
C3843040 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C1514873 (UMLS CUI [2,3])
C0683933 (UMLS CUI [2,4])
C0004936 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C0683933 (UMLS CUI [3,3])
C0438215 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
C0683933 (UMLS CUI [4,3])
C0683933 (UMLS CUI [5,1])
C1444641 (UMLS CUI [5,2])
C1113679 (UMLS CUI [5,3])
Study Subject Participation Status | Investigational New Drugs
Item
8. subjects who participated in another clinical study/received investigational product within 30 days of screening for this study.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])