Phase 2 Completed N=58 Randomized Treatment

A Phase 2 Study to Evaluate Safety and Efficacy of Abiraterone Acetate in Male Participants With Prostate Cancer

Source: ClinicalTrials.gov NCT00924469 ↗

Enrolled (actual)

Serious AEs

22.4%

Results posted

Apr 2013

Primary outcomePrimary: Testosterone Concentration in Prostate Tissue — 0.089; 0.228 Picogram per milligram (pg/mg) — p=0.0216

Summary

The purpose of this study is to evaluate safety and efficacy of abiraterone acetate plus leuprolide acetate and prednisone, versus leuprolide acetate alone in male participants with prostate cancer (a disease in which cells in the prostate gland become abnormal and start to grow uncontrollably, forming tumors) who are suitable candidates for prostatectomy (surgery to remove all or part of the prostate gland).

Outcome Measures

Outcome	Result	p-value
PRIMARY Testosterone Concentration in Prostate Tissue	0.089; 0.228	0.0216 sig
PRIMARY Dihydrotestosterone (DHT) Concentration in Prostate Tissue	4.311; 2.170	<0.0001 sig
SECONDARY Testosterone and Dihydrotestosterone (DHT) Concentration in Prostate Tissue	0.216; 0.062; 1.340; 2.456	0.1423
SECONDARY Androstenedione and Dehydroepiandrosterone (DHEA) Concentrations in Prostate Tissue	0.082; 0.277; 0.090; 0.070; 1.994; 29.241	<0.0001 sig
SECONDARY Serum Levels of Androgens	1.049; 10.014; 0.648; 3.122; 6.143; 5.797	<0.0001 sig
SECONDARY Percentage of Participants With Prostate-specific Antigen (PSA) Response	86.7; 3.6; 86.7; 82.1	<0.0001 sig
SECONDARY Percentage of Participants With Pathologic Complete Response (CR)	10.3; 3.7	0.3427
SECONDARY Number of Participants With Tumor Expression of Androgen Receptor (AR) Regulated Genes at Week 24	—	—
SECONDARY Correlation Between Molecular and Protein Expression With Intracellular Androgen Levels and Pathologic Response to Study Treatment	—	—

Eligibility Criteria

Inclusion Criteria

Histologically or cytologically confirmed adenocarcinoma of the prostate
At least three core biopsies positive for prostate cancer (a minimum of 6 core biopsies must be obtained at baseline). A prostate biopsy within 6 months from Screening is allowed for entry requirements
At least one of the following features: prostate specific antigen (PSA) greater than (>) 10 nanogram per milliliter (ng/ml); PSA velocity >2 ng/ml per /year (defined as a rise in PSA of >2 ng/ml in the preceding 12 month period); Gleason score greater than or equal to (>=) 7 (4+3); Gleason score 6 if either PSA >=10 ng/ml or PSA velocity >=2 ng/ml/year
Serum testosterone >200 nanogram/deciliter
Participant and urologist must agree that participant is suitable for prostatectomy

Exclusion Criteria

Serious or uncontrolled co-existent, non-malignant disease, including active and uncontrolled infection
Abnormal liver function consisting of any of the following: serum bilirubin >= 1.5 * upper limit of normal (ULN); aspartate aminotransferase or alanine aminotransferase >=2.5 * ULN
Uncontrolled hypertension within the Screening period (systolic blood pressure >= 160 millimeter of mercury [mmHg] or diastolic BP >= 95 mmHg)
Requirement for corticosteroids greater than the equivalent of 5 milligram of prednisone daily
Participants with active or symptomatic viral hepatitis or chronic liver disease or clinically significant heart disease or as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) Class II-IV heart disease or cardiac ejection fraction measurement of < 50 percent at Baseline or history of gastrointestinal disorders (medical disorders or extensive surgery) which may interfere with the absorption of the study drug or history of pituitary or adrenal dysfunction

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00924469). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.