Phase II, Randomized Study of Patients With Rising PSA at High-Risk of Progression After Primary Therapy to Assess the Clinical and Molecular Efficacy of the Enzastaurin - Bicalutamide Combination to Suppress the Androgen Receptor Without Testosterone Ablation
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Comparison of proportion of patients with undetectable prostate-specific antigen PSA level (< 0.2 ng/mL) at 44 weeks
研究概览
简要总结
RATIONALE: Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as bicalutamide, may lessen the amount of androgens made by the body. Enzastaurin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving bicalutamide together with enzastaurin is more effective than bicalutamide alone in treating prostate cancer.
PURPOSE: This randomized phase II trial is studying bicalutamide to see how well it works compared with giving bicalutamide together with enzastaurin in treating patients with prostate cancer.
详细描述
OBJECTIVES:
Primary
- To compare the two regimens on the proportion of patients with undetectable prostate-specific antigen (PSA) level (< 0.2 ng/mL) at 44 weeks.
Secondary
- To assess the proportion of patients with PSA decline > 85% at 44 weeks on the combination therapy arm compared to that of bicalutamide monotherapy arm.
- To assess the distribution of best PSA response in each study arm.
- To assess the time to PSA progression and the time to PSA nadir in each arm of the study.
- To assess the duration of PSA response in each arm of the study.
- To characterize the PSA slope before, during, and after treatment.
- To evaluate the safety and tolerability of enzastaurin hydrochloride in this patient population.
- To determine whether Gleason score or prior hormonal therapy has any effect on PSA response to treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm A
Patients are observed without treatment in weeks 1-12. Patients with a prostate-specific antigen (PSA) rise of > 50% above baseline or nadir (whichever is lowest) and a rise of at least 5 ng/mL, confirmed by a repeat PSA at least 2 weeks later, may be started on bicalutamide before the end of week 12 at the discretion of the treating physician. In weeks 13-44, patients with a rise PSA ≥ 50% above baseline or nadir, and a PSA rise of at least 5 ng/mL confirmed by a repeat PSA at least 2 weeks later, are removed from study. Patients receive oral bicalutamide once daily. Patients achieving a PSA decline ≥ 50% in the absence of toxicity may continue to receive bicalutamide up to 72 weeks.
干预措施: bicalutamide (Drug)
Arm B
In weeks 1-12, patients receive oral enzastaurin hydrochloride twice daily. Patients with a PSA rise of > 50% above baseline or nadir, and a rise of at least 5 ng/mL, confirmed by a repeat PSA at least 2 weeks later, may be started on bicalutamide before the end of week 12 at the discretion of the treating physician. In weeks 13-44, patients with a PSA rise of ≥ 50% above baseline or nadir, and a rise of at least 5 ng/mL, confirmed by a repeat PSA at least 2 weeks later, are removed from study. Patients receive oral enzastaurin twice daily and oral bicalutamide once daily. Patients achieving a PSA decline ≥ 50% in the absence of toxicity may continue on this combination therapy up to 72 weeks.
干预措施: bicalutamide (Drug)
Arm B
In weeks 1-12, patients receive oral enzastaurin hydrochloride twice daily. Patients with a PSA rise of > 50% above baseline or nadir, and a rise of at least 5 ng/mL, confirmed by a repeat PSA at least 2 weeks later, may be started on bicalutamide before the end of week 12 at the discretion of the treating physician. In weeks 13-44, patients with a PSA rise of ≥ 50% above baseline or nadir, and a rise of at least 5 ng/mL, confirmed by a repeat PSA at least 2 weeks later, are removed from study. Patients receive oral enzastaurin twice daily and oral bicalutamide once daily. Patients achieving a PSA decline ≥ 50% in the absence of toxicity may continue on this combination therapy up to 72 weeks.
干预措施: enzastaurin hydrochloride (Drug)
结局指标
主要结局
Comparison of proportion of patients with undetectable prostate-specific antigen PSA level (< 0.2 ng/mL) at 44 weeks
次要结局
- Comparison of proportion of patients achieving ≥ 85% PSA decline at 44 weeks
- PSA response
- Time to PSA progression
- Time to PSA nadir
- Duration of PSA response
- PSA slope at baseline, during, and after treatment
- Effect of Gleason score and prior hormonal therapy on PSA response to treatment