A Prospective Observational Cohort Study of Efficacy and Safety of Darolutamide in Combination With Androgen-Deprivation Therapy in Prostate Cancer Patients With Lymph Node-positive After Radical Prostatectomy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Time to CRPC
研究概览
简要总结
This study is an open, prospective, single-center observational clinical study to evaluate the efficacy and safety of immediate adjuvant ADT with darotarolimide in the treatment of patients with positive lymph nodes after radical prostatectomy for prostate cancer.
详细描述
This study is an open, prospective, single-center observational clinical study to evaluate the efficacy and safety of immediate adjuvant ADT with darotarolimide in the treatment of patients with positive lymph nodes after radical prostatectomy for prostate cancer. The study evaluates the efficacy of immediate adjuvant ADT with darotarolimide in patients with positive lymph nodes after radical prostatectomy for prostate cancer, using time to achieve CRPC as the primary study endpoint. OS will be examined in all patients after the primary study endpoint is achieved and will serve as the key secondary study endpoint. It is planned to enroll 108 patients with positive lymph nodes after radical prostatectomy for prostate cancer. It is divided into a screening period, a treatment period and a follow-up period. Patients will enter the screening period from the time they sign the informed consent form, and those who have been evaluated and qualified in the screening period will be entered into the study. Patients eligible for enrollment will receive 2 years of ADT treatment or ADT treatment + darotarotide adjuvant therapy with or without combination radiotherapy at the investigator's discretion.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •patients voluntarily enrolled in the study and signed an informed consent form;
- •aged 18-80 years (including 18 and 80 years), male;
- •diagnosed with prostate adenocarcinoma by pathology or cytology;
- •Eastern Cooperative Oncology Group (ECOG) Physical Status (PS) score 0-
- •patients who have undergone radical prostatectomy (RP) and pelvic lymph node dissection (PLND) without non-regional lymph node metastasis, bone metastasis, or metastasis to other sites (e.g., visceral metastasis) as confirmed by conventional imaging (bone imaging, CT, or MRI) or PSMA PET/CT
- •have positive postoperative pathologic lymph nodes (pN1);
- •with their consent and have signed an informed consent form.
排除标准
- •Patients will not be enrolled if they have any of the following:
- •have histologic features of neuroendocrine differentiation or small cell carcinoma;
- •have received prior treatment for prostate cancer: postoperative systemic therapy including ADT for >3 months, conventional endocrine therapy (e.g., flutamide, bicalutamide) for >3 months, novel endocrine therapy (e.g., dalotamide, abiraterone, abatacept, enzalutamide), chemotherapy (e.g., docetaxel), immunotherapy, and targeted therapies
- •Inability to tolerate Darotamine or ADT treatment;
- •persons who are allergic or have a known history of allergy to darotarolimide or ADT;
- •other conditions that the investigator considers inappropriate for inclusion.
研究组 & 干预措施
Darolutamide in addition to androgen deprivation therapy
Darolutamide 600mg twice daily. The ADT regimen was either a gonadotropin-releasing hormone analog agonist or a gonadotropin-releasing hormone antagonist.The ADT administration type, frequency, and dose were determined by the investigator.
干预措施: Darolutamide in addition to androgen deprivation therapy (Drug)
androgen deprivation therapy only
The ADT regimen was either a gonadotropin-releasing hormone analog agonist or a gonadotropin-releasing hormone antagonist.The ADT administration type, frequency, and dose were determined by the investigator.
干预措施: androgen deprivation therapy only (Drug)
结局指标
主要结局
Time to CRPC
时间窗: Time from initiation to the occurrence of PSA progression or imaging progression, whichever occurs first.
castrate resistant prostate cancer
次要结局
- MFS(Time to metastasis or death confirmed from enrollment imaging, whichever occurred first)
- rPFS(Time from initiation to imaging progression or death from any cause, whichever occurs first)
- PSA-PFS(Time from initiation to PSA progression or death, whichever occurs first)