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正在招募III 期编号 NCT03903835

ProBio: A Biomarker Driven Study in Patients With Metastatic Prostate Cancer

报名条件（概要）

  • 年龄：18 Years – 不限
  • 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

Belgium、Norway、Sweden、Switzerland

药品与企业信息

Enzalutamide Oral Capsule药物

其他名称：Xtandi

Detailed conditions for the use of the study treatments including dose and dosages are described in accordance with the marketing authorization in the SmPC (Summary of Product Characteristics).

Abiraterone Oral Tablet药物

其他名称：Zytiga

Detailed conditions for the use of the study treatment including dose and dosages are described in accordance with the marketing authorisation in the SmPC.

Carboplatin药物

Carboplatin will be administered every 3rd week with an AUC (area under curve) = 5 with a dose calculated according to the Carboplatin AUC Dose calculation (Calvert formula):Dose (mg) = TargetAUC (mg/ml x min) x \[GFR ml/min + 25\].

Cabazitaxel 60 mg Solution for Injection药物

Detailed conditions for the use of the study treatment including dose and dosages are described in accordance with the marketing authorisation in the SmPC.

Docetaxel Injectable Solution药物

Detailed conditions for the use of the study treatment including dose and dosages are described in accordance with the marketing authorisation in the SmPC.

Radium Chloride Ra-223药物

其他名称：Xofigo

Detailed conditions for the use of the study treatment including dose and dosages are described in accordance with the marketing authorisation in the SmPC.

Niraparib plus Abiraterone acetate plus Prednisone药物

其他名称：Akeega

Niraparib and Abiraterone acetate will be provided by Janssen and will be provided either as a fixed dose combination or as single agents. Detailed use of the study treatment including dose and dosages are described in the Investigator's brochures and SmPC.

Capivasertib plus Docetaxel药物

Capivasertib is provided by AstraZeneca and will be given in combination with Docetaxel. All subjects will be given up to ten 21-day docetaxel cycles. All subjects will receive Capivasertib, which will be administered as tablets taken twice a day orally, on a 4 days on/3 days off continuous schedule, commencing cycle one, day 2, until disease progression.

研发企业

Karolinska Institutet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

Enzalutamide Oral Capsule

Astellas Pharma US, Inc.

Radium Chloride Ra-223

Bayer HealthCare Pharmaceuticals Inc.

合作机构

  • The Swedish Research CouncilOTHER_GOV
  • Kom Op Tegen Kanker研究机构/其他
  • Janssen Pharmaceutica N.V., Belgium企业
  • AstraZeneca企业
  • CancerfondenUNKNOWN

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）

ProBio is an international, outcome-adaptive, multi-arm, open-label, multiple assignment randomized biomarker driven platform trial in patients with metastatic prostate cancer. Patients will be randomized to control or experimental treatment arms. Patients in the control arm will receive standard of care following national guidelines. Patients in the experimental arm will be randomized to treatments based on a biomarker signature inferred from diagnostic tissue or liquid biopsy profiling. The predefined biomarker signatures are tumor properties or mutations in genes/pathways with previously demonstrated clinical validity (e.g. prognostic value or association with treatment response). The biomarker signatures are identified using a hybridisation capture gene panel specifically designed for prostate cancer.

适应症

Metastatic Castration-resistant Prostate Cancer (mCRPC)Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

主动联系研究团队

这项试验目前在中国大陆没有研究中心

这种情况下，直接发"入组咨询"往往会被回复"您所在地区没有中心"。更有效的做法是申请同情用药／扩展准入（由主治医生一同提出），或询问能否到最近的境外中心参加。下面已为您切换到对应的信件版本。

查看完整申请路径与成功率说明 →

总联系人（申办方／研究总部）

研究中心联系方式

问自己是否符合条件、如何预筛

我的病情档案

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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: ProBio: A Biomarker Driven Study in Patients With Metastatic Prostate Cancer
ClinicalTrials.gov Identifier: NCT03903835
Sponsor: Karolinska Institutet
Investigational product: Enzalutamide Oral Capsule, Abiraterone Oral Tablet, Carboplatin, Cabazitaxel 60 mg Solution for Injection, Docetaxel Injectable Solution

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：ProBio: A Biomarker Driven Study in Patients With Metastatic Prostate Cancer
试验编号：NCT03903835
申办方：Karolinska Institutet
研究药物：Enzalutamide Oral Capsule、Abiraterone Oral Tablet、Carboplatin、Cabazitaxel 60 mg Solution for Injection、Docetaxel Injectable Solution

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 berit.larsson@ki.se

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