Biomarker Study Targeting Abiraterone Metabolites and Polymporphisms in Men With PSA Progression on Abiraterone for the Treatment of Castration Resistant or Castration Sensitive Prostate Cancer (The Bio-STAMP Study)
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Number of patients with radiographic progression free survival (rPFS) rate
研究概览
简要总结
This is a multicenter, Phase II randomized biomarker-based therapeutic study in metastatic prostate cancer experiencing prostate specific antigen (PSA) only progression (without visceral, bone or lymph node progression) while on abiraterone therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological or cytological evidence of adenocarcinoma of the prostate
- •Undergone orchiectomy, or have been on luteinizing hormone-releasing hormone (LHRH) agonists or antagonists for at least 3 months prior to study enrollment. Patients on LHRH agonists/antagonists must remain on these agents for the duration of the study.
- •Currently receiving abiraterone (ZYTIGA or FDA approved generic) in the castration sensitive (CSPC) or castration resistant (CRPC) setting with PSA progression in the absence of visceral, bone or lymph node progression. PSA progression is defined as an increase in the PSA level of more than 50% above the nadir with two consecutive increases at least 2 weeks apart (based on Prostate Cancer Working Group Criteria, version 3 (PCWG3).
- •Minimum PSA must be ≥1.0 ng/dL.
- •Age 18 years of age or older.
- •ECOG performance status 0 or
- •Have adequate organ function confirmed by the following laboratory values obtained within 14 days prior to enrollment:
- •absolute neutrophil count (ANC) ≥ 1.5 × 10^9/L
- •platelets ≥ 100 × 10^9/L
- •hemoglobin ≥ 10 g/dL, independent of transfusion ≤14 days of screening
- •aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN); if liver metastases, then ≤ 5 × ULN
- •total bilirubin ≤ 1.5 × ULN; < 2 × ULN if hyperbilirubinemia is due to Gilbert's syndrome
- •serum albumin ≥ 30 g/L (3.0 g/dL)
- •Serum creatinine ≤ 1.5 x ULN; OR estimated glomerular filtration rate (GFR) ≥ 45 mL/min using the Cockcroft Gault formula
- •Participants with partners of childbearing potential must be willing to use at least two forms of effective birth control (one form must be a barrier method) during the dutasteride treatment period and for 6 months after last dose or 3 weeks after the last dose of abiraterone whichever is longer. Persons are considered to be of childbearing potential unless one or the following applies:
- •Is postmenopausal, defined as no menses for at least 12 months without an alternative medical cause
- •Considered permanently sterile. Permanent sterilization includes hysterectomy, bilateral salpingectomy, and/or bilateral oophorectomy.
- •Voluntary written consent prior to the performance of any research related activit
排除标准
- •Previously demonstrated, clinically significant hypersensitivity (e.g., serious skin reactions, angioedema) to 5 alpha-reductase inhibitors (i.e. finasteride).
- •Prior use of Enzalutamide, Apalutamide, or Darolutamide for the treatment of prostate cancer.
研究组 & 干预措施
1245c positive (1245c+) patients with dutasteride
Continue on abiraterone 1000 mg PO daily with dutasteride 3.5 mg PO daily as an add-on therapy until radiographic progression is documented
干预措施: Dutasteride (Drug)
1245c positive (1245c+) patients with dutasteride
Continue on abiraterone 1000 mg PO daily with dutasteride 3.5 mg PO daily as an add-on therapy until radiographic progression is documented
干预措施: Abiraterone (Drug)
1245c positive (1245c+) patients
Continue on abiraterone 1000 mg PO daily (the standard of care for PSA only progression) until radiographic progression is documented
干预措施: Abiraterone (Drug)
1245c negative (1245c-) patients
abiraterone 1000 mg PO daily (the standard of care for PSA only progression) until radiographic progression is documented
干预措施: Abiraterone (Drug)
结局指标
主要结局
Number of patients with radiographic progression free survival (rPFS) rate
时间窗: 24 Weeks after study treatment
Count the the number of patients with radiographic progression free survival (rPFS)
次要结局
- Determine overall survival (OS)(24 months from start of treatment assignment)
- Number of patients with a PSA decline of ≥ 50%(24 weeks of adding of adding high-dose dutasteride)