Disease Progression | Placebo given | Raised prostate specific antigen
Item
documented disease progression while on placebo in the gup-0205-1 or gup-0205-1xx study (a ≥100% increase over baseline serum psa with a minimum increase of 1.0 ng/ml.
boolean
C0242656 (UMLS CUI [1])
C0420256 (UMLS CUI [2])
C0178415 (UMLS CUI [3])
Informed Consent
Item
willingness and ability to sign an informed consent document.
boolean
C0021430 (UMLS CUI [1])
Pomegranate Extract Other Absent
Item
agreement with complete abstinence from other commercially available pomegranate products during the course of the study.
boolean
C1961993 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Dietary Supplements Dose Stable | Herbal Supplements Dose Stable | Saw palmetto extract | Selenium
Item
use of dietary/herbal supplements (e.g., saw palmetto, selenium, etc) are acceptable provided the dose has been stable for at least 2 months prior to screening and the subject agrees not to change/stop during the course of the study.
boolean
C0242295 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C1504473 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0771607 (UMLS CUI [3])
C0036581 (UMLS CUI [4])
ECOG performance status
Item
performance status 0 or 1 on the ecog scale at time of entry into this extension study.
boolean
C1520224 (UMLS CUI [1])
Comorbidity Study Subject Participation Status Poor | Mental condition Study Subject Participation Status Poor
Item
significant concomitant medical or psychiatric condition that, in the opinion of the investigator, would make the subject a poor protocol candidate.
boolean
C0009488 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C2700379 (UMLS CUI [1,3])
C3840291 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C2700379 (UMLS CUI [2,3])
Hormone Therapy | Exception Antiandrogen therapy Neoadjuvant | Serum testosterone measurement
Item
hormonal therapy, with the exception of neoadjuvant androgen deprivation therapy (adt) prior to or concurrent with primary therapy. subjects who underwent neoadjuvant adt cannot have a serum testosterone of ≤150 ng/ml at study entry.
boolean
C0279025 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0279492 (UMLS CUI [2,2])
C0600558 (UMLS CUI [2,3])
C0428413 (UMLS CUI [3])
Hormone Therapy | Raised prostate specific antigen | Status post Induction Therapy Prostate carcinoma
Item
concomitant or antecedent hormonal therapy for rising serum psa after initial therapy of prostate cancer.
boolean
C0279025 (UMLS CUI [1])
C0178415 (UMLS CUI [2])
C0231290 (UMLS CUI [3,1])
C0600558 (UMLS CUI [3,2])
C0600139 (UMLS CUI [3,3])
Protocol Compliance Unable | Protocol Compliance Unwilling
Item
subjects unable or unwilling to comply with protocol requirements.
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Experimental drug | Steroids High dose | Cancer treatment
Item
prior treatment with experimental drugs, high dose steroids, or with any other cancer treatment within 4 weeks prior to the first dose of study product and for the duration of the study.
boolean
C0304229 (UMLS CUI [1])
C0038317 (UMLS CUI [2,1])
C0444956 (UMLS CUI [2,2])
C0920425 (UMLS CUI [3])
Raised prostate specific antigen | Prostate specific antigen measurement | Study Subject Participation Status Unfavorable
Item
serum psa >7.0 ng/ml (assessed at termination of the double-blind study or et of the double-blind extension gup-0205-1xx); at any psa level, the subject will be excluded if determined by the investigator that the subject's continued participation would not be in their best interest).
boolean
C0178415 (UMLS CUI [1])
C0201544 (UMLS CUI [2])
C2348568 (UMLS CUI [3,1])
C3640815 (UMLS CUI [3,2])
Prostate-Specific Antigen Doubling Time
Item
serum psa doubling time <13 weeks (assessed at termination of the double-blind study or et of the double-blind extension gup-0205-1xx)).
boolean
C0138741 (UMLS CUI [1,1])
C2986483 (UMLS CUI [1,2])
Neoplasm Metastasis Physical Examination | Neoplasm Metastasis CT | Neoplasm Metastasis Bone scan
Item
evidence of metastatic disease on physical examination or on ct or bone scan.
boolean
C0027627 (UMLS CUI [1,1])
C0031809 (UMLS CUI [1,2])
C0027627 (UMLS CUI [2,1])
C0040405 (UMLS CUI [2,2])
C0027627 (UMLS CUI [3,1])
C0203668 (UMLS CUI [3,2])
Finasteride | Dutasteride
Item
use of finasteride, dutasteride at any point since primary therapy or during the study.
boolean
C0060389 (UMLS CUI [1])
C0754659 (UMLS CUI [2])
Raised laboratory findings
Item
clinically significant abnormal laboratory value greater than 2 times the upper limit of normal (>2xuln).
boolean
C0586721 (UMLS CUI [1])