EUCTR2021-000943-30-ES进行中（未招募）1 期
Randomized phase II study evaluating the clinical utility of switching from prednisone to dexamethasone after initial biochemical progression in patients with hormone-sensitive metastatic prostate cancer treated with abiraterone
SOGUG (Spanish Genitourinary Oncologic Group)0 个研究点目标入组 110 人开始时间: 2021年7月27日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 110
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •1. Informed consent.
- •2. Age equal to or older than 18 years.
- •3. Eastern Cooperative Oncology Group Performance Status (ECOG PS) < or = 2.
- •4. Histological confirmation of the diagnosis of prostate adenocarcinoma, with no predominance of microcytic or neuroendocrine component.
- •5. Patients on treatment with abiraterone 1000mg/24h + prednisone 5mg/24h + androgen deprivation (LHRH analogues or surgical castration) with indication in metastatic hormone-sensitive prostate cancer for at least 12 weeks.
- •6. Biochemical progression, defined as:
- •a. PSA elevation greater than 25% above nadir, confirmed by a second determination at least 2 weeks later. For inclusion it will be necessary to document both the initial progression value and the confirmation value.
- •b. PSA value > or = 2 ng/mL.
- •c. Documented progression after at least 12 weeks of treatment.
- •7. Blood testosterone levels <0.5 ng/mL.
- •8. Absence of radiological progression to abiraterone plus prednisone as determined by the investigator, with no new visceral or nodal lesions, or less than 3 new bone lesions.
- •9. Adequate hematologic, hepatic, and renal function as defined by the following parameters:
- •a. Hematologic:
- •i. Hemoglobin > 9 g/dL
- •ii. Leukocytes > 2,000/mm 3
- •iii. Neutrophils > 1,000/mm 3
- •iv. Platelets > 75,000/mm 3
- •b. Hepatic:
- •i. GOT < 1.5*LSN (in case of hepatic metastases, < 5*LSN).
- •ii. GPT < 1.5*LSN (in case of hepatic metastases, < 5*LSN)
- •iii. Total bilirubin < 1.5*LSN (in case of hepatic metastases, < 3*LSN)
- •i. Creatinine < 2*LSN
- •ii. Creatinine clearance > 30 mL/min.
- •10. Absence of contraindication for administration of abiraterone acetate according to the data sheet.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1. Radiological progression in the baseline radiological evaluation, according to RECIST and PCWG3 criteria.
- •2. Presence of clinically relevant symptomatology related to the disease, defined as:
- •a. Significant pain (score > or = 3 on the Brief Pain Inventory - Short Form (BPI-SF), item 3).
- •b. Presence of adverse effects > or = grade 2 that, in the judgment of the investigator, related to the baseline disease (adverse effects related to the toxicity of the related treatment will be accepted).
- •3. Biochemical, radiological or clinical progression in the 12 weeks since initiation of abiraterone + prednisone for the treatment of CPHSm.
- •4. Prior diagnosis of cancer, except:
- •a. Patients diagnosed with a localized malignant tumor treated with curative intent, free of disease after curative intent, free of disease after 3 years.
- •b. Patients diagnosed with skin tumors (of non-melanoma type) or intervened carcinomas in situ.
- •5. Any comorbidity that, in the judgment of the investigator, contraindicates the administration of dexamethasone as an adjuvant corticoid to treatment with abirateracetate with abiraterone acetate.
- •6. Medical, psychiatric or any other condition, which, in the investigator's judgment, would interfere with the interferes with the subject's ability to give informed consent, or safely carry out the procedures required in the study.
研究者
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