Testing the Effects of Low Dose Apalutamide on Prostate-Specific Antigen (PSA) Levels in Men Scheduled for Removal of the Prostate Gland
Clinical Study of Bioactivity of Low Dose Apalutamide in Prostate Cancer Patients Scheduled for Prostatectomy
Sponsor: National Cancer Institute (NCI)
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Change in Prostate Specific Antigen (PSA) Levels
Time frame: Baseline to end-of-intervention (mean 4.8 weeks; up to 9 weeks)
Secondary Endpoints
Reversibility of Testosterone Levels
Post-intervention Plasma Trough Apalutamide Concentrations
Health-related Quality of Life (HRQOL)
Eligibility Criteria
Inclusion Criteria: * Histologically confirmed organ-confined adenocarcinoma of the prostate (PCa) suitable for prostatectomy * Gleason score =\< (4+4), however no Gleason pattern 5 * Current serum PSA =\< 20 ng/ml * Age \> 18 years * Karnofsky \>= 70% * Leukocytes \>= 3,000/uL * Absolute neutrophil count \>= 1,500/uL * Platelets \>= 100,000/uL * Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN) (note: in subjects with Gilbert's syndrome, if total bilirubin is \> 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is =\< 1.5 x ULN, subject may be eligible) * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]) \< 2.5 x institutional ULN * Creatinine \< 2 x institutional ULN * Thyroid stimulating hormone (TSH) within the institutional normal range * Willing to use adequate contraception (barrier method; abstinence; subject has had a vasecto…
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