NCT06029036招募中2 期
A Phase II, Multi-center, Single-arm, Prospective Study of Darolutamide + ADT Prior to Radical Prostatectomy (RP) in High-risk/Very High-risk Localized Prostate Cancer
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Rate of pathological downstaging
研究概览
简要总结
Scientific Rationale: High risk localized prostate cancer (PCa) is associated with higher rates of biochemical recurrence, clinical recurrence, metastasis and PCa-specific death. Novel hormone therapies(NHT) have shown a significant survival advantage with respect to classical ADT in later stages of PCa and have already been investigated in neoadjuvant setting.
PURPOSE: To assess antitumor effect by measuring pathological tumor volume with pathological downstaging following radical prostatectomy + pelvic lymph-node dissection (RP + PLND) for high-risk localized prostate cancer patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male ≥18 years of age.
- •Able to Sign informed consent form independently.
- •Non-metastatic adenocarcinoma of the prostate.
- •Subjects must have as least one of the following features according to NCCN definition of high-risk: Gleason score ≥8, or PSA >20ng/ml,or≥clinical T3a.
- •Subjects with pelvic lymph node involvement(N1) can be included.
- •Candidate for radical prostatectomy with or without pelvic lymph node dissection as per the investigator.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or
- •Subjects must have normal organ and marrow function as defined below:
- •Hemoglobin ≥ 9.0 g/dL;Absolute neutrophil count (ANC) ≥ 1,500/mcL; Platelets ≥ 100,000/mcL, independent of transfusions/growth factors within 3 months of treatment start; Serum potassium ≥ 3.5 mmol/L; Serum total bilirubin ≤ 2.0 x upper limit of normal (ULN) (except in subjects with Gilbert's syndrome who have a total bilirubin > 1.5 x ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤ 1.5 x ULN, subject may be eligible);Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 x ULN;Serum albumin ≥ 3.0 g/dL;Serum creatinine < 2.0 x ULN.
排除标准
- •Prostate cancer with neuroendocrine differentiation or small cell features
- •Distant metastasis based on conventional imaging (clinical stage M1). Nodal disease below the iliac bifurcation (clinical stage N1) is not an exclusion.
- •History of prior systemic or local therapy for prostate cancer, including pelvic radiation for prostate cancer.
- •Subjects who are planning bilateral orchidectomy during the treatment period of the study.
- •Intolerable with darolutamide or ADT treatment.
- •Candidates of other clinical trials.
- •Any prior malignancy within 5 years.
- •Complications include significant cardiovascular disease, active infection, astrointestinal disorders, or any other complications that in the opinion of the investigator.
- •Any condition that in the opinion of the investigator would preclude participation in this study.
研究组 & 干预措施
Darolutamide + ADT
Experimental
Duration of treatment: 28-day cycle of darolutamide treatment and 6 cycles of neoadjuvant therapy.
干预措施: Darolutamide+ADT (Drug)
结局指标
主要结局
Rate of pathological downstaging
时间窗: 6 months
Percentage of patients with tumor downstaging
次要结局
- pCR or MRD(6 months)
- PSM(6 months)
- Rate of peri-operative complications(within 30 days of surgery)
- Biochemical complete response(6 months)
- PSA undetectable rate(12 months post-RP)
- 2-year biochemical progression-free survival, bPFS(24 months post-RP)
- AEs/SAEs(Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first)
研究者
研究点 (1)
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