A Randomized, Open-Label, Neoadjuvant Prostate Cancer Trial of Abiraterone Acetate Plus LHRHa Versus LHRHa Alone
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 66
- 主要终点
- Number of Participants With a Pathology Tumor Stage of Less Than or Equal to Prostate Cancer Stage at Which the Tumor is Confined to the Prostate (pT2)
研究概览
简要总结
The goal of this clinical research study is to find out how treatment with abiraterone acetate in combination with prednisone and a Luteinizing Hormone-Releasing Hormone (LHRH) analogue changes the tumor in comparison to treatment with an LHRH analogue alone.
Objectives:
Primary Objective:
To assess the difference in pathologic stage < pT2 between Group A and Group B.
Secondary Objective:
- To assess and compare the changes in levels of androgens (pre, during, and post treatment) in the serum, primary tumor microenvironment and bone marrow between Group A and Group B.
- To assess changes in biomarkers related to androgen signaling and other cancer-related pathways between Group A and Group B.
- To assess the difference in rate of positive surgical margins between Group A and Group B.
- To assess the safety profile of abiraterone acetate and low dose prednisone in a preoperative setting.
详细描述
Study Groups:
Participants who are eligible to take part in this study will be randomly assigned (as in the flip of a coin) to 1 of 2 groups:
- Those who are in Group A will take abiraterone acetate, a LHRH analogue, and prednisone.
- Those who are in Group B will receive a LHRH analogue alone. Participants will have 2 out of 3 chances of being placed in Group A or 1 out of 3 chances of being placed in Group B.
Participants in both groups will receive the study drug(s) for about 3 months followed by a prostatectomy (prostate surgery) between 2 and 4 weeks after they stop taking the study drug(s).
Length of Study:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Histological proof of prostatic adenocarcinoma via a minimum of 6 core biopsy samples
- •Clinical stage T1c or T2 with high-grade disease (Gleason's 8-10) on initial biopsy, or clinical stage T2b-T2c with Gleason's grade >/= 7 and PSA > 10ng/ml.
- •No evidence of metastatic disease as determined by CT scans and bone scans.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of </= 1
- •Patients should have adequate bone marrow function defined as an absolute peripheral granulocyte count (ANC) > 1,500 and platelet count of > 100,
- •Normal pituitary and adrenal function
- •Patients should be deemed to be candidates for radical prostatectomy.
排除标准
- •Histological variants in the primary tumor (histological variants other than adenocarcinoma); neuroendocrine tumor
- •Serious or uncontrolled co-existent non-malignant disease, including active and uncontrolled infection
- •Uncontrolled hypertension
- •Abnormal Liver function
- •Active or symptomatic viral hepatitis or chronic liver disease
- •Clinically significant heart disease
- •Other active malignancy
- •History of gastrointestinal disorders (medical disorders or extensive surgery) which may interfere with the absorption of the study drug
- •Previous treatment with abiraterone acetate
- •Patients who are not appropriate surgical candidates for radical prostatectomy
- •Prior chemotherapy or radiation therapy for prostate cancer.
- •Condition or situation which, in the investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with patient's participation in the study
- •Note: There are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.
研究组 & 干预措施
AA+LHRHa
Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) and 1,000 mg abiraterone acetate (AA) plus 5 mg of prednisone daily for 3 months prior to radical prostatectomy.
干预措施: Abiraterone Acetate (Drug)
AA+LHRHa
Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) and 1,000 mg abiraterone acetate (AA) plus 5 mg of prednisone daily for 3 months prior to radical prostatectomy.
干预措施: Prednisone (Drug)
AA+LHRHa
Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) and 1,000 mg abiraterone acetate (AA) plus 5 mg of prednisone daily for 3 months prior to radical prostatectomy.
干预措施: LHRHa (Drug)
LHRHa
Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) prior to radical prostatectomy.
干预措施: LHRHa (Drug)
结局指标
主要结局
Number of Participants With a Pathology Tumor Stage of Less Than or Equal to Prostate Cancer Stage at Which the Tumor is Confined to the Prostate (pT2)
时间窗: At the end of Cycle 3 (at radical prostatectomy)
The table below shows number of participants in each treatment group with a pathology tumor stage less than or equal to pT2.
次要结局
- Number of Participants With a Positive Surgical Margin at Radical Prostatectomy(At the end of Cycle 3 (at radical prostatectomy))
- Number of Participants With Prostate-Specific Antigen Response(Cycle 3 Day 1)