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正在招募II 期编号 NCT07711314

Adjuvant Rezvilutamide Monotherapy for High-Risk Prostate Cancer After Radical Prostatectomy

报名条件（概要）

  • 年龄：18 Years – 75 Years
  • 性别：男性
  • 健康志愿者：不接受

完整入排标准请以官方页面为准。

开展国家/地区

China

药品与企业信息

Rezvilutamide Tablets药物

Patients will receive rezvilutamide monotherapy orally at a dose of 240 mg (three 80 mg tablets) once daily. The medication must be swallowed whole and can be taken with or without food. Treatment is initiated between 4 to 12 weeks following radical prostatectomy and continues for 12 consecutive 28-day cycles (totaling 48 weeks). Unlike standard adjuvant regimens or previous metastatic trials that combine novel hormone agents with traditional androgen deprivation therapy (ADT), this study evaluates rezvilutamide strictly as a single-agent therapy. It specifically targets patients with localized prostate cancer who have achieved a postoperative PSA \< 0.1 ng/mL but have a high risk of recurrence (CAPRA-S score ≥ 6). If patients experience ≥ Grade 3 or intolerable toxicity, the dose may be interrupted and subsequently reduced to 160 mg or 80 mg daily.

研发企业

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School研究机构/其他

试验官方登记的主要申办方；研究机构申办时会显示相应机构名称。

生产企业

公开药品批准资料或正式说明书暂未提供明确的生产企业信息。

合作机构

  • Shengli Oilfield Hospital研究机构/其他
  • The Second Hospital of Anhui Medical University研究机构/其他

研发企业与生产企业可能不是同一家。研究阶段药品可能尚未公布生产企业；生产企业仅取自美国上市原研药说明书所列企业（不含仿制药），不作推测；仅在其他国家上市的药品暂无法显示。

研究简介（原文）

Prostate cancer patients with high-risk features who undergo radical prostatectomy (RP) are at a significant risk of biochemical recurrence (BCR) and disease progression. While adjuvant androgen deprivation therapy (ADT) with or without radiotherapy is the current standard of care, long-term ADT is associated with substantial adverse effects, including metabolic syndrome, cardiovascular disease, and bone density loss, which negatively impact patients' quality of life. There is an unmet clinical need to optimize adjuvant treatment strategies to improve survival outcomes while minimizing treatment-related toxicity for this high-risk population. Rezvilutamide is a novel, potent, second-generation oral androgen receptor (AR) inhibitor. This prospective, multicenter, single-arm clinical trial aims to evaluate the efficacy and safety of rezvilutamide monotherapy as an adjuvant treatment in patients with localized prostate cancer who have a high risk of recurrence following radical prostatectomy. The study plans to enroll 48 male patients (aged 18-75 years) who have completed radical prostatectomy within 12 weeks, have achieved a postoperative prostate-specific antigen (PSA) level of \< 0.1 ng/mL within 8 weeks, and possess a high recurrence risk defined by a CAPRA-S score of ≥ 6. Eligible patients will receive rezvilutamide monotherapy at a dose of 240 mg orally once daily for 12 cycles (28 days per cycle, totaling 48 weeks). The primary endpoint of the study is the 2-year biochemical progression-free survival (bPFS) rate. Secondary endpoints include event-free survival rate, 5-year bPFS, 5-year metastasis-free survival (MFS), testosterone recovery rate and time at 2 years, overall safety, and health-related quality of life assessed by the FACT-P and EPIC-26 questionnaires. By exploring this monotherapy approach, the study hopes to provide a new, effective, and better-tolerated adjuvant treatment option that can improve the prognosis of high-risk patients post-prostatectomy.

适应症

Prostate Cancer (Post Prostatectomy)

主动联系研究团队

总联系人（申办方／研究总部）

中国／港澳台研究中心

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英文版（发给研究团队）

Dear Study Team,

I am a patient in China and I am interested in participating in your clinical trial:

Study Title: Adjuvant Rezvilutamide Monotherapy for High-Risk Prostate Cancer After Radical Prostatectomy
ClinicalTrials.gov Identifier: NCT07711314
Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Investigational product: Rezvilutamide Tablets

About me:
- Age: (please fill in)
- Sex: (please fill in)
- Confirmed diagnosis and stage: (please fill in)
- Biomarkers / genetic testing: not available
- Prior and current treatments: (please fill in)
- Performance status (ECOG): not assessed
- Current location: China
- Travel ability: (please fill in)

Could you please let me know:
1. Whether I might be eligible for this study;
2. Which site would be closest and most practical for me, and whether remote pre-screening is possible;
3. What documents (medical records, pathology or imaging reports, recent labs) I should prepare for pre-screening.

I can provide English translations of my medical records. Thank you very much for your time and help.

Kind regards,
(your name)
(your email / phone with country code)

中文对照（供您核对）

尊敬的研究团队：

我是一位来自中国的患者，希望咨询参加以下临床试验的可能：

研究名称：Adjuvant Rezvilutamide Monotherapy for High-Risk Prostate Cancer After Radical Prostatectomy
试验编号：NCT07711314
申办方：The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
研究药物：Rezvilutamide Tablets

我的基本情况：
- 年龄：（请填写）
- 性别：（请填写）
- 确诊疾病与分期：（请填写）
- 基因／标志物检测：暂无
- 既往及当前治疗：（请填写）
- 体能状态（ECOG）：未评估
- 目前所在城市：中国
- 可前往范围：（请填写）

想请教三个问题：
1. 我是否可能符合本研究的入组标准？
2. 哪个中心对我最方便可行？能否远程预筛？
3. 预筛需要准备哪些资料（病历、病理、影像、近期化验）？

我可以提供英文翻译版病历。感谢您的时间与帮助。

顺祝安康
（您的姓名）
（您的邮箱／带国际区号的电话）
用邮件客户端发送给 Xuefeng_qiu@nju.edu.cn

提示：请与主治医生一起发信——由医生署名的申请，回复率远高于患者单独发信。首封邮件不要附身份证号等敏感信息。研究团队通常在 3–10 个工作日内回复，两周无回音可礼貌追问一次。

下一步怎么做？

  1. 把本页信息带给您的主治医生，评估是否适合参加。
  2. 点击下方按钮打开官方注册页，查看研究中心联系方式。
  3. 直接联系研究团队咨询报名事宜（通常有中文同声翻译服务可协助沟通）。
在 ClinicalTrials.gov 查看官方页面