Propranolol Combined With Novel Endocrine Therapy and Androgen Deprivation Therapy (ADT) for Neoadjuvant Treatment in High-Risk Prostate Cancer Patients: A Multicenter, Single-Arm Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- pathological complete response
研究概览
简要总结
Propranolol, a non-selective adrenergic beta-receptor blocker, is conventionally used to treat arrhythmias. However, recent studies have demonstrated its therapeutic efficacy in breast cancer, prostate cancer, neonatal hemangioma, and neonatal facial rhabdomyoma. Given the significant potential of neoadjuvant therapy in prostate cancer, we designed a multicenter, single-arm clinical study. This trial evaluates neoadjuvant propranolol combined with novel endocrine therapy and androgen deprivation therapy (ADT) in high-risk prostate cancer patients prior to radical prostatectomy, aiming to achieve superior curative outcomes.
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 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years and ≤ 85 years;
- •High-risk prostate cancer patients. High-risk prostate cancer is defined as: organ-confined high-risk/very high-risk prostate cancer and locally advanced prostate cancer. High-risk/very high-risk is specifically defined as PSA > 20 ng/mL, biopsy Gleason score ≥ 8, or clinical T stage cT2c or higher, meeting at least one of these three criteria, and without distant metastasis. Local progression typically refers to pelvic lymph node metastasis only; ③ Patients diagnosed with mild to moderate primary hypertension according to the Chinese Hypertension Prevention and Treatment Guidelines (2024 Revised Edition). Hypertension is defined as:
- •Office blood pressure ≥140/90 mmHg without antihypertensive medication; or home blood pressure ≥135/85 mmHg; or 24-hour ambulatory blood pressure ≥130/80 mmHg, with daytime blood pressure ≥135/85 mmHg and nighttime blood pressure ≥120/70 mmHg. Specifically: - Systolic blood pressure 140-159 mmHg and/or diastolic blood pressure 90-99 mmHg constitutes mild hypertension; - Systolic blood pressure 160-179 mmHg and/or diastolic blood pressure 100-109 mmHg constitutes moderate hypertension.
- •For patient screening, office blood pressure must meet any one of the following criteria:
- •Primary hypertension patients who have not used any antihypertensive medication for at least 4 weeks prior to screening, with an average seated office blood pressure (mean of 3 measurements) of 150 mmHg ≤ SBP < 180 mmHg and DBP < 110 mmHg;
- •Patients with primary hypertension who have been on stable doses of 1-2 antihypertensive agents (including monotherapy, dual therapy, or fixed-dose combinations) for at least 4 weeks prior to screening, and who are deemed clinically suitable for switching to propranolol or nifedipine, with an average seated office blood pressure of 140 mmHg ≤ SBP < 180 mmHg and DBP < 110 mmHg; ⑤ ECOG (Eastern Cooperative Oncology Group) performance status of 0-1;
- •⑥ All patients voluntarily sign informed consent and are able to adhere to treatment and follow-up;
- •⑦ Prostate cancer biopsy specimens and surgically resected tissue are available for subsequent analysis, with sufficient tumor cell content in the pathological specimens;
排除标准
- •Any prior or ongoing PCa treatment, including radiotherapy, chemotherapy, ADT, etc.;
- •Individuals contraindicated for propranolol. Specifically including: 1) Patients with asthma and allergic rhinitis; 2) Patients with cardiovascular disease: sinus bradycardia, severe atrioventricular block, cardiogenic shock; 3) Patients with cardiac insufficiency; 4) Patients with hepatic impairment; 5) Patients with hypothyroidism; ③ Patients who have recently (within 3 months) taken beta-blocker medications (e.g., carvedilol, metoprolol);
- •Patients with known allergies to any medication used; ⑤ Patients on long-term antiarrhythmic drugs (e.g., amiodarone, sotalol, digoxin, verapamil, flecainide); ⑥ Patients deemed unsuitable for this clinical study by the investigator's judgment;
研究组 & 干预措施
Propranolol combined with novel endocrine therapy and androgen deprivation therapy
干预措施: Propranolol combined with novel endocrine therapy and androgen deprivation therapy (Drug)
结局指标
主要结局
pathological complete response
时间窗: From enrollment to the end of treatment at 12 weeks
pCR (pathological complete response) is defined as the absence of morphologically recognizable cancer in the prostate resection specimen.
Minimal Residual Disease
时间窗: From enrollment to the end of treatment at 12 weeks
MRD (Minimal Residual Disease) is defined as residual tumors with a maximum cross-sectional dimension ≤5 mm and a residual cancer burden (RCB) ≤0.25 cm³ (tumor volume ≤0.5 cm³ × tumor cell content ≤50%). Tumor volume is calculated via three-dimensional volume estimation based on the maximum cross-sectional dimension and number of cross-sections involved, with correction for tumor cell architecture.
次要结局
未报告次要终点
研究者
baotai Liang
doctor
Zhongda Hospital