Neoadjuvant ADT +/- Darolutamide Followed by Radical Prostatectomy for High-risk Prostate Cancer: a Randomized, Open Label Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Pathologic Complete Response Rate
研究概览
简要总结
The purpose of this study is to determine if treatment with Darolutamide plus androgen deprivation therapy (ADT) before radical prostatectomy (RP) with pelvic lymph node dissection (pLND) in participants with high-risk localized or locally advanced prostate cancer results in an improvement in pathological complete response (pCR) rate and pathological tumor volume with minimal residual disease (MRD)) as compared to ADT.
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 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients must be ≥ 18 and ≤75 years of age.
- •All patients must have a histologically or cytologically diagnosis of prostate cancer and must be eligible for radical prostatectomy.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status score ≤
- •All patients must complete mpMRI or 68Ga-PSMA PET / CT before and after neoadjuvant treatment.
- •All patients must undergo thorough tumor staging and meet one of the following criteria:
- •multi-parameter MRI or PSMA PET / CT shows clinical staging of primary tumor ≥ cT2c or cN+or locally advanced,
- •Gleason score of primary tumor ≥ 8,
- •prostate specific antigen (PSA) ≥20 ng/ml.
- •Patients must have adequate organ function as defined by the following criteria(within 28 days prior to registration):
- •white blood cell (WBC) ≥ 4.0 × 109 / L platelets≥ 100 × 109 / L hemoglobin ≥ 9 g / dL international normalized ratio (INR) < 1.
- •total bilirubin (TBIL)≤1.5 x upper limit of normal (ULN) SGOT (AST) and SGPT (ALT) ≤ 2.5 x ULN serum creatinine ≤2×ULN
- •Patients must participate voluntarily and sign an informed consent form (ICF), indicating that they understand the purpose and required procedures of the study, and are willing to participate in. Patients must be willing to obey the prohibitions and restrictions specified in the research protocol.
排除标准
- •clinical or radiological evidence of regional or extra-regional lymph node metastases or bone metastases or visceral metastases.
- •Prior androgen deprivation therapy (medical or surgical) or focal treatment of prostate cancer or prostate cancer radiotherapy or prostate cancer chemotherapy.
- •severe or uncontrolled concurrent infections.
- •New York Heart Association Class III or IV congestive heart failure at the time of screening.
- •uncontrolled severe hypertension, persistent uncontrolled diabetes, oxygen-dependent lung disease, chronic liver disease, or HIV infection.
- •Patients with mental illness, mental disability or inability to give informed consent are not eligible.
- •Patients have had other malignancies other than prostate cancer in the past 5 years, but cured basal cell or squamous cell skin cancers can be enrolled.
研究组 & 干预措施
Darolutamide Plus ADT
All participants in this arm will receive luteinizing hormone releasing hormone analogue (LHRHa) plus Darolutamide. Goserelin 3.6 mg will be used once per 4 weeks. Darolutamide will be administered orally as 600 mg twice a day. Subjects will continue to take Darolutamide Plus Goserelin for 12 weeks before radical prostatectomy
干预措施: Darolutamide (Drug)
Darolutamide Plus ADT
All participants in this arm will receive luteinizing hormone releasing hormone analogue (LHRHa) plus Darolutamide. Goserelin 3.6 mg will be used once per 4 weeks. Darolutamide will be administered orally as 600 mg twice a day. Subjects will continue to take Darolutamide Plus Goserelin for 12 weeks before radical prostatectomy
干预措施: Goserelin 3.6 mg (Drug)
ADT alone
All participants in this arm will receive LHRHa alone for 12 weeks before receiving radical prostatectomy. Goserelin 3.6 mg will be administered once per 4 weeks.
干预措施: Goserelin 3.6 mg (Drug)
结局指标
主要结局
Pathologic Complete Response Rate
时间窗: After 12 weeks of neoadjuvant therapy + RP + PLND
The proportion of subjects with no morphologically recognizable cancer cell in tumor specimens after radical prostatectomy
Proportion of Subjects With Minimal Residual Disease
时间窗: After 12 weeks of neoadjuvant therapy + RP + PLND
The proportion of subjects that have residual tumors with maximum diameter of 5 mm or less after radical prostatectomy
次要结局
- Proportion of subjects without PSA progression(2 years after RP)
- Recovery time of urinary continence (day)(1 years after RP)
- Rate of Stage Degradation(After 12 weeks of neoadjuvant therapy + RP + PLND)
- Rate of Positive Surgical Margins(After 12 weeks of neoadjuvant therapy + RP + PLND)
- Imaging Response Rate(After 12 weeks of neoadjuvant therapy)
- Rate of Complete Serum Remission(After 12 weeks of neoadjuvant therapy)
- biochemical recurrence-free survival (bRFS)(3 years after RP)
- metastasis-free survival (MFS)(5 years after RP)