ACTRN12623000160639尚未招募2 期
A Randomized, Open-Label, Phase 2 Study of Darolutamide as Single Agent or in Combination with EPI-7386 as a Neoadjuvant Treatment for Patients Undergoing Prostatectomy for Localized Prostate Cancer (DaSCENT)
St Vincent's Hospital Sydney0 个研究点目标入组 32 人开始时间: 2023年2月16日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- Male
入选标准
- •1. Willing and able to provide informed consent;
- •2. Men greater than or equal to 18 years of age;
- •3. Histologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features with a 5 yr progression free probability of less than 80% as per the MSKCC calculator (https://www.mskcc.org/nomograms/prostate/pre_op);
- •4. Must be candidates for radical prostatectomy and considered surgically resectable by urologic evaluation;
- •5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1;
- •6. No evidence of metastatic disease outside the pelvis as determined by radionuclide bone scans and computed tomography/magnetic resonance imaging OR PSMA-PET scan;
- •7. Able to swallow the study drug(s) as prescribed and comply with study requirements;
- •8. Archived prostate biopsy tissue sample available or willing to undergo fresh biopsy.
排除标准
- •1. Received an investigational agent within 4 weeks prior to randomization;
- •2. Stage T4 prostate cancer by clinical examination or radiologic evaluation;
- •3. Hypogonadism or severe androgen deficiency as defined by screening serum testosterone below the normal range for the institution;
- •4. Prior androgen deprivation, anti-androgen, chemotherapy, surgery, or radiation for prostate cancer;
- •5. Receiving concurrent androgens, estrogens, or progestational agents, or received any of these agents within the 6 months prior to randomization;
- •6. History of another malignancy within the previous 2 years other than curatively treated non-melanomatous skin cancer, superficial bladder cancer or other cancers unlikely to affect study outcomes;
- •7. Uncontrolled intercurrent illness, including, but not limited to, active infection or deep venous thrombosis within 3 months prior to randomization;
- •8. Severe concurrent disease, infection, or co-morbidity that, in the judgment of the Investigator, would make the patient inappropriate for enrollment;
- •9. Unwilling to use contraceptives while on study and for 3 months after study (subjects are required to use barrier protection with sexual partners);
- •10. Any of the following laboratory values obtained within 14 days prior to randomization:
- •Absolute neutrophil count < 1500/µL, platelet count < 100,000/µL, or hemoglobin < 10 g/dL) (patients may not have received any growth factors within 7 days or blood transfusions within 28 days of the hematologic laboratory values obtained at the Screening visit)
研究者
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