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临床试验/NCT00924469
NCT00924469
已完成
2 期

A Phase 2 Open-Label, Randomized, Multi-center Study of Neoadjuvant Abiraterone Acetate (CB7630) Plus Leuprolide Acetate and Prednisone Versus Leuprolide Acetate Alone in Men With Localized High Risk Prostate Cancer

Janssen Research & Development, LLC0 个研究点目标入组 58 人2009年11月

概览

阶段
2 期
干预措施
Abiraterone
疾病 / 适应症
Prostate Cancer
发起方
Janssen Research & Development, LLC
入组人数
58
主要终点
Testosterone Concentration in Prostate Tissue
状态
已完成
最后更新
13年前

概览

简要总结

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).

详细描述

This is an open-label (all people know the identity of the intervention), randomized (the study drug is assigned by chance), and multi-center (conducted in more than one center) study of abiraterone in male participants with prostate cancer. The duration of study will be approximately 24-32 weeks per participant. The study consists of 4 parts: Screening (that is, 30 days before study commences on Day 1); Treatment (abiraterone acetate 1000 milligram per day or leuprolide acetate as 22.5 milligram intramuscular injection \[injection of a substance into a muscle\] or prednisone 5 mg once daily); Prostatectomy (Week 24); and Follow-up ( 4-8 weeks after prostatectomy). Participants will receive either abiraterone, leuprolide and prednisone for 24 weeks (that is, Group 1) or leuprolide once every 12 weeks up to Week 24 then abiraterone and prednisone from Week 13 to 24 (that is, Group 2). All the eligible participants will be randomly assigned to 1 of the 2 treatment groups. Efficacy will be evaluated primarily through the concentrations of testosterone and dihydrotestosterone from prostate tissues at Week 12. Participants' safety will be monitored throughout the study.

注册库
clinicaltrials.gov
开始日期
2009年11月
结束日期
2012年3月
最后更新
13年前
研究类型
Interventional
研究设计
Parallel
性别
Male

研究者

责任方
Sponsor

入排标准

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Abiraterone plus leuprolide plus prednisone

Abiraterone acetate tablets will be administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate will be administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone tablets will be administered orally as 5 mg once daily for 24 weeks.

干预措施: Abiraterone

Abiraterone plus leuprolide plus prednisone

Abiraterone acetate tablets will be administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate will be administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone tablets will be administered orally as 5 mg once daily for 24 weeks.

干预措施: Leuprolide

Abiraterone plus leuprolide plus prednisone

Abiraterone acetate tablets will be administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate will be administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone tablets will be administered orally as 5 mg once daily for 24 weeks.

干预措施: Prednisone

Leuprolide then abiraterone plus leuprolide plus prednisone

Leuprolide acetate will be administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets will be administered orally at a total dose of 1000 mg per day with prednisone tablets administered orally as 5 mg once daily.

干预措施: Abiraterone

Leuprolide then abiraterone plus leuprolide plus prednisone

Leuprolide acetate will be administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets will be administered orally at a total dose of 1000 mg per day with prednisone tablets administered orally as 5 mg once daily.

干预措施: Leuprolide

Leuprolide then abiraterone plus leuprolide plus prednisone

Leuprolide acetate will be administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets will be administered orally at a total dose of 1000 mg per day with prednisone tablets administered orally as 5 mg once daily.

干预措施: Prednisone

结局指标

主要结局

Testosterone Concentration in Prostate Tissue

时间窗: Week 12

Testosterone is a potent androgen (a hormone that promotes the development and maintenance of male characteristics) and major product secreted by cells in the testis and produced in the adrenal glands and by prostate cancers. Abiraterone acetate affects sources of testosterone in the body (ie, adrendal gland and prostate tumor). Testosterone concentration was measured in prostate tissues after exposure to study treatments at Week 12.

Dihydrotestosterone (DHT) Concentration in Prostate Tissue

时间窗: Week 12

The DHT is a potent androgenic metabolite of testosterone and the concentration of DHT was measured in prostate tissues after exposure to study treatments at Week 12.

次要结局

  • Testosterone and Dihydrotestosterone (DHT) Concentration in Prostate Tissue(Week 24)
  • Androstenedione and Dehydroepiandrosterone (DHEA) Concentrations in Prostate Tissue(Week 12 and 24)
  • Serum Levels of Androgens(Week 12 and 24)
  • Percentage of Participants With Prostate-specific Antigen (PSA) Response(Weeks 12 and 24)
  • Percentage of Participants With Pathologic Complete Response (CR)(Week 24)
  • Number of Participants With Tumor Expression of Androgen Receptor (AR) Regulated Genes at Week 24(Week 24)
  • Correlation Between Molecular and Protein Expression With Intracellular Androgen Levels and Pathologic Response to Study Treatment(Week 24)

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