GTx-758 on Serum Prostate-specific Antigen (PSA) in Men With Castrate Resistant Prostate Cancer (NCT01420861) | Clinical Trial Compass
TerminatedPhase 2
GTx-758 on Serum Prostate-specific Antigen (PSA) in Men With Castrate Resistant Prostate Cancer
Stopped: FDA Clinical Hold
United States18 participantsStarted 2011-09
Plain-language summary
The purpose of this study is to assess the effect of GTx-758 on Serum Prostate-specific antigen (PSA) levels in men with castrate resistant prostate cancer who are maintained on androgen deprivation therapy (Serum PSA response and Serum PSA progression)
Who can participate
Age range18 Years – 80 Years
SexMALE
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Inclusion criteria
✓. Be over 18 years of age
✓. Be able to communicate effectively with the study personnel
✓. Have histologically confirmed prostate cancer
✓. ECOG performance status of 0 to 2
✓. Have been treated with ADT(chemical or surgical) for at least 6 months
✓. Have castrate level of serum total testosterone (\<50 ng/dL)
✓. Have a history of serum PSA response after initiation of ADT, serum PSA response is at least a 90% reduction in serum PSA to \<10 ng/mL OR undetectable level of serum PSA (less tan or =0.2 ng/mL)
✓. Have rising serum PSA on two successive assessments at least 2 weeks apart and serum PSA levels ≥ 2 ng/mL or 2ng/mL and a 25% increase over the nadir after the initiation of ADT
Exclusion criteria
✕. Known hypersensitivity or allergy to estrogen or estrogen like drugs;
✕. Have symptomatic metastatic prostate cancer
✕. Any disease or condition (medical or surgical) which might compromise the hematologic, cardiovascular, endocrine, pulmonary, renal, gastrointestinal, hepatic, or central nervous system; or other conditions that may interfere with the absorption, distribution, metabolism or excretion of study drug, or would place the subject at increased risk;
. History of abnormal blood clotting, Factor V Leiden clotting disorder, thrombotic disease (venous or arterial thrombotic events such as history of stroke, deep vein thrombosis (DVT), and/or pulmonary embolus (PE))
✕. Symptomatic congestive heart failure (NYHA Class III - IV), unstable angina pectoris, cardiac arrhythmia
✕. The presence of consistently abnormal laboratory values which are considered clinically significant. In addition, no subject with liver enzymes (ALT or AST) above 2 times the ULN, total bilirubin above 2 times the ULN, or serum creatinine above 1.5 ULN will be admitted to the study
✕. Received an investigational drug within a period of 90 days prior to enrollment in the study