Disease Progression Absent | Product Clinical Trial Specified | Raised prostate specific antigen Absent
Item
no evidence of disease progression while on any of the three gup-0205 study products (disease progression defined as > 100% increase in serum psa [with a minimum value of 1.0 ng/ml]).
boolean
C0242656 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1254351 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
C0205369 (UMLS CUI [2,3])
C0178415 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
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) is acceptable provided the dose has been stable during the course of the gup-0205- 1 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])
Comorbidity Study Subject Participation Status At risk | Mental condition Study Subject Participation Status At risk | Comorbidity compromises Study Protocol | Mental condition compromises Study Protocol
Item
significant concomitant medical or psychiatric condition that, in the opinion of the principal investigator, would put the subject at risk or compromise the protocol.
boolean
C0009488 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C3840291 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C1444641 (UMLS CUI [2,3])
C0009488 (UMLS CUI [3,1])
C2945640 (UMLS CUI [3,2])
C2348563 (UMLS CUI [3,3])
C3840291 (UMLS CUI [4,1])
C2945640 (UMLS CUI [4,2])
C2348563 (UMLS CUI [4,3])
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; at any psa level, the subject will be excluded if determined by the principal 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).
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])