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A Phase 3 Study of [177Lu]Ludotadipep for Metastatic Castration-Resistant Prostate Cancer

2026年9月28日 更新者：FutureChem

A Multi-center, Open-label, Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of [177Lu]Ludotadipep Treatment for Metastatic Castration-resistant Prostate Cancer

Primary Efficacy Endpoint

- Radiographic Progression-Free Survival (rPFS): rPFS is defined as the time from randomization to radiographic disease progression (PD), as assessed by Blinded Independent Central Review (BICR) according to PCWG3-modified RECIST version 1.1, or death from any cause, whichever occurs first.

rPFS will be analyzed using the Kaplan-Meier method. The median survival time and corresponding two-sided 95% confidence intervals (CIs) will be estimated for both the investigational and control arms, and Kaplan-Meier curves will be presented.

A comparison between the investigational and control arms will be performed using a stratified Cox proportional hazards regression model. The model will be adjusted for the following stratification factors: nomogram score (≥178 vs <178), ECOG Performance Status (0 or 1 vs 2), prior use of cabazitaxel before randomization (yes vs no), and receipt of best supportive care alone (yes vs no). The p-value will be reported.

Ties in event times will be handled using the Efron method. The hazard ratio (HR) of the investigational arm relative to the control arm and its corresponding two-sided 95% confidence interval will be provided.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

Study Procedures:

  • Before randomization, investigators determine the most appropriate BSC/SoC for each participant.
  • Participants start BSC/SoC from Cycle 1 Day 1 (C1D1). [177-Lu]Ludotadipep is administered every 8 weeks for up to 4 cycles; investigators may allow up to 6 cycles based on clinical judgment. (Participants who do not meet criteria or decline additional [177-Lu]Ludotadipep after 4 cycles will continue BSC/SoC alone.)
  • Control arm participants who experience radiographic disease progression may cross over to receive [177-Lu]Ludotadipep in combination with BSC/SoC after obtaining separate consent and confirming eligibility.
  • "Cross-over" is defined as [177-Lu]Ludotadipep treatment in the control arm after progression. "Cross-over screening" refers to the eligibility confirmation process for cross-over.

研究类型

介入性

注册 (估计的)

114

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 韩国
      • Gyeonggi-do、韩国
        • 招聘中
        • National Cancer Center
        • 接触：
      • Seoul、韩国
        • 招聘中
        • Samsung Medical Center
        • 接触：
      • Seoul、韩国
        • 招聘中
        • Seoul National University Hospital
        • 接触：
      • Seoul、韩国
        • 招聘中
        • Severance Hospital
        • 接触：
          • Seung Hwan Lee
          • 电话号码：82 2 1599 1004
          • 邮箱：LEESEH@yuhs.ac
      • Seoul、韩国
        • 招聘中
        • Seoul St. Mary's Hospital
        • 接触：
      • Seoul、韩国
        • 招聘中
        • Ewha Woman University Medical Center
        • 接触：
      • Seoul、韩国
        • 尚未招聘
        • Korea University ANAM Hospital
        • 接触：
      • Suwon、韩国
        • 招聘中
        • St. Vincent's Hospital
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

19年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

男性

描述

Inclusion Criteria:

  1. Adult male aged ≥19 years at the time of written informed consent.

  2. Histologically, pathologically, or cytologically confirmed prostate adenocarcinoma without small cell features.

  3. Patients with progressive metastatic castration-resistant prostate cancer (mCRPC) meeting at least one of the following criteria:

    1. PSA progression: Minimum PSA level of ≥2.0 ng/mL with at least two consecutive increases at intervals of ≥1 week.
    2. Soft tissue progression:

    i. ≥20% increase in the sum of diameters (SOD)* of target lesions compared to the smallest SOD since treatment initiation, or ii. Appearance of one or more new lesions.

    *Short axis for lymph nodes and long axis for non-nodal lesions. (c) Bone progression: Appearance of ≥2 new lesions on bone scan.

  4. At least one metastatic lesion documented by CT, MRI, or bone scan within 4 weeks prior to baseline.

  5. Castration-resistant status with serum testosterone ≤50 ng/dL (≤1.7 nmol/L), achieved by surgical or medical castration.

    Patients without bilateral orchiectomy receiving LHRH analogs must continue such therapy throughout the study.

  6. Prior therapy meeting all of the following:

    1. At least one novel anti-androgen drug (NAAD) (e.g., enzalutamide and/or abiraterone).

      (First-generation anti-androgens such as bicalutamide, flutamide, and nilutamide are not counted.)

    2. At least one, but no more than two, prior taxane regimens. Patients who have not received docetaxel may be enrolled if deemed unsuitable, refused treatment, or lack access.

  7. COG performance status ≤2.

  8. Life expectancy of at least 24 weeks.

  9. PSMA-positive mCRPC confirmed by [18F]PSMA PET/CT at screening by independent central review, meeting all of the following:

    1. At least one PSMA-positive metastatic lesion§.

      §Defined as uptake greater than liver background, regardless of organ system or lesion size.

    2. No PSMA-negative lesions∥. ∥Defined as metastatic lesions with uptake equal to or lower than liver background and measurable on CT¶.

      • i. Bone lesions with soft tissue component ≥1 cm (short axis) ii. Solid organ metastases ≥1 cm (short axis) iii. Lymph nodes ≥2.5 cm (short axis)

  10. Adequate bone marrow, hepatic, and renal function at screening (one repeat test allowed during screening).

  11. Agreement to avoid fathering a child and to use effective contraception from screening until 24 weeks after the last dose of study drug, and to refrain from sperm donation.

    Acceptable contraception methods include hormonal contraception, intrauterine device/system, surgical sterilization, double-barrier methods, or complete abstinence.

  12. Planned best supportive care/standard of care (BSC/SoC) must be permitted in this study, and both investigator and patient agree that disease management with BSC/SoC alone is appropriate.

  13. Ability to understand the study and provision of written informed consent prior to any study-specific procedures.

Exclusion Criteria:

  1. Prior treatment with any of the following therapies:

    1. PSMA-targeted radioligand therapy
    2. Systemic radionuclide therapy within 24 weeks prior to the first dose of study intervention (e.g., strontium-89, samarium-153, rhenium-186, rhenium-188, radium-223, or hemi-body irradiation)
    3. Any other anticancer therapy (including cytotoxic chemotherapy, immunotherapy, biologic therapy, or targeted therapy) within 4 weeks prior to randomization

  2. History of any of the following:

    1. Hypersensitivity to the active substance or any component of the investigation
    2. History of another primary malignancy within 3 years prior to screening, except for adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, superficial bladder cancer, papillary thyroid cancer, or carcinoma in situ with no recurrence for at least 2 years, as judged by the investigator
    3. Clinically significant cardiovascular disease within 24 weeks prior to screening, including but not limited to:

    i. Myocardial infarction or severe/unstable angina ii. Congestive heart failure (NYHA Class III or IV) iii. QTcF >480 msec on ECG iv. Clinically significant seizures or conditions predisposing to seizures v. Symptomatic or impending spinal cord compression (d) Known human immunodeficiency virus (HIV) infection

  3. Presence of any of the following comorbidities:

    1. Uncontrolled hypertension (SBP ≥160 mmHg or DBP ≥90 mmHg)
    2. Symptomatic or uncontrolled central nervous system metastases (Patients may be eligible if clinically and radiologically stable for ≥4 weeks and off anticonvulsants and corticosteroids for ≥2 weeks prior to study treatment)
    3. Immunocompromised status (including splenectomy or hematopoietic stem cell transplantation) or active autoimmune disease (e.g., myasthenia gravis, Hashimoto's thyroiditis, rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosus, scleroderma)
    4. Severe infection or other uncontrolled active infection that may interfere with study assessments, as judged by the investigator
    5. Active hepatitis B or C infection:

    Hepatitis B: Defined as HBsAg positive at screening; however, patients may be eligible if HBV DNA <500 IU/mL and on stable antiviral therapy for ≥2 weeks prior to first dose, with intent to continue during the study and for ≥24 weeks after the last dose Hepatitis C: Defined as HCV antibody positive; patients are eligible if HCV RNA is negative

  4. Presence of a superscan on bone scan at baseline.

  5. Failure to recover to baseline or ≤ Grade 1 from prior anticancer therapy-related toxicities (except for alopecia of any grade or other conditions deemed acceptable per eligibility criteria).

  6. Participation in another clinical study with administration of an investigational product or device within 4 weeks prior to the first dose of study intervention.

  7. Any other condition that, in the opinion of the investigator, would make the subject unsuitable for participation in the study.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：交叉作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：[177-Lu]Ludotadipep plus best supportive care/standard of care (BSC/SOC)

Each participant will receive 3.7 GBq (+/- 10%) [177-Lu]Ludotadipep every 8 weeks for a total of 4 cycles, with the possibility of up to 6 cycles based on clinical judgment. Best supportive care/standard of care (BSC/BSOC) might be used.
药品：[177-Lu]Ludotadipep

[177-Lu]Ludotadipep 3.7 GBq (+/- 10%) intravenously every 8 weeks for a maximum of 6 cycles.

其他：Best supportive care/standard of care (BSC/SOC) alone

Best supportive care/standard of care as defined by the investigator.
有源比较器：BSC/SoC

Control arms will receive best supportive care/standard of care (BSC/SoC) permitted in the trial, according to the investigator's discretion and the standard practices of the study site.
其他：Best supportive care/standard of care (BSC/SOC) alone

Best supportive care/standard of care as defined by the investigator.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Radiographic Progression-Free Survival (rPFS)
大体时间：up to 36 months.

Radiographic progression-free survival (rPFS) is defined as the time from the date of randomization to the date of first documented radiographic disease progression or death from any cause, whichever occurs first, as assessed by blinded independent central review (BICR) according to PCWG3-modified RECIST version 1.1.

Median rPFS and two-sided 95% confidence intervals (CIs) for each treatment group will be estimated using the Kaplan-Meier method, and Kaplan-Meier curves will be presented.

Treatment groups will be compared using a stratified Cox proportional hazards regression analysis, adjusting for stratification factors (nomogram score [>178 vs. ≤178], ECOG performance status [0-1 vs. 2], prior cabazitaxel use, and best supportive care alone). Ties will be handled using the Efron method. The hazard ratio (HR) for the treatment group relative to the control group, along with its two-sided 95% CI and corresponding p-value, will be reported.
up to 36 months.

次要结果测量

结果测量
措施说明
大体时间
Radiographic Progression-Free Survival (rPFS)
大体时间：up to 36 months.

Radiographic progression-free survival (rPFS) is defined as the Time from the date of randomization to the date of first documented radiographic disease progression or death from any cause, whichever occurs first, as assessed by blinded independent central review (BICR) and investigator according to RECIST version 1.1 and RECIP 1.0(RECIP BICR Only).

Median rPFS and two-sided 95% confidence intervals (CIs) for each treatment group will be estimated using the Kaplan-Meier method, and Kaplan-Meier curves will be presented.

Treatment groups will be compared using a stratified Cox proportional hazards regression analysis, adjusting for stratification factors (nomogram score [>178 vs. ≤178], ECOG performance status [0-1 vs. 2], prior cabazitaxel use, and best supportive care alone). Ties will be handled using the Efron method. The hazard ratio (HR) for the treatment group relative to the control group, along with its two-sided 95% CI and corresponding p-value, will be reported.
up to 36 months.
Overall Survival (OS)
大体时间：up to 36 months.

Overall survival (OS) is defined as the time from the date of randomization to the date of death from any cause.

Median OS and two-sided 95% confidence intervals (CIs) for each treatment group will be estimated using the Kaplan-Meier method, and Kaplan-Meier curves will be presented.

Treatment groups will be compared using a stratified Cox proportional hazards regression analysis, adjusting for stratification factors (nomogram score [>178 vs. ≤178], ECOG performance status [0-1 vs. 2], prior cabazitaxel use, and best supportive care alone). Ties will be handled using the Efron method. The hazard ratio (HR) for the treatment group relative to the control group, along with its two-sided 95% CI and corresponding p-value, will be reported.
up to 36 months.
Duration of Response (DOR)
大体时间：up to 36 months.

Duration of response (DOR) is defined as the time from the date of first documented partial response (PR) or complete response (CR) to the date of first documented radiographic disease progression (PD), as assessed by blinded independent central review (BICR) and investigator according to RECIST v1.1, PCWG3-modified RECIST v1.1, and RECIP 1.0 (RECIP BICR only).

Median DOR and two-sided 95% confidence intervals (CIs) for each treatment group will be estimated using the Kaplan-Meier method, and Kaplan-Meier curves will be presented.

Treatment groups will be compared using a stratified Cox proportional hazards regression analysis, adjusting for stratification factors (nomogram score [>178 vs. ≤178], ECOG performance status [0-1 vs. 2], prior cabazitaxel use, and best supportive care alone). Ties will be handled using the Efron method. The hazard ratio (HR) for the treatment group relative to the control group, along with its two-sided 95% CI and corresponding p-value, will be reported.
up to 36 months.
Progression-Free Survival (PFS)
大体时间：up to 36 months.

Progression-free survival (PFS) is defined as the time from the date of randomization to the date of first documented radiographic progression, PSA progression, clinical progression, or death from any cause, whichever occurs first, as assessed by investigator according to RECIST v1.1 and PCWG3-modified RECIST v1.1.

Median PFS and two-sided 95% confidence intervals (CIs) for each treatment group will be estimated using the Kaplan-Meier method, and Kaplan-Meier curves will be presented.

Treatment groups will be compared using a stratified Cox proportional hazards regression analysis, adjusting for stratification factors (nomogram score [>178 vs. ≤178], ECOG performance status [0-1 vs. 2], prior cabazitaxel use, and best supportive care alone). Ties will be handled using the Efron method. The hazard ratio (HR) for the treatment group relative to the control group, along with its two-sided 95% CI and corresponding p-value, will be reported.
up to 36 months.
Objective Response Rate (ORR)
大体时间：up to 36 months.

Objective response rate (ORR) is defined as the proportion (%) of participants who achieve a best overall response of complete response (CR) or partial response (PR), as assessed by BICR and investigator according to RECIST v1.1, PCWG3-modified RECIST v1.1, and RECIP 1.0 (RECIP 1.0 assessed by BICR only).

Frequencies, percentages, and two-sided 95% CIs will be presented for each treatment group. Between-group comparisons will be performed using a stratified logistic regression model, adjusting for stratification factors (nomogram score [>178 vs. ≤178], ECOG performance status [0-1 vs. 2], prior cabazitaxel use, and best supportive care alone). The odds ratio (OR) for the treatment group relative to the control group, along with its two-sided 95% CI and corresponding p-value, will be reported.
up to 36 months.
Health-Related Quality of Life (HRQoL) - BPI-SF (Brief Pain Inventory - Short Form)
大体时间：Baseline and Day 1 of each cycle during treatment

Evaluated using Brief Pain Inventory - Short Form (BPI-SF). Pain severity items range from 0 (no pain) to 10 (pain as bad as you can imagine), calculated as the mean of 4 items. Pain interference items range from 0 (does not interfere) to 10 (completely interferes), calculated as the mean of 7 items. Lower scores represent less pain and interference (better outcome); higher scores represent greater pain and interference (worse outcome).

Summary statistics (N, mean, SD, median, min, max) for baseline and post-baseline will be reported. Between-group comparisons will be analyzed using Analysis of Covariance (ANCOVA) on change from baseline, with treatment group as a fixed effect, and baseline score and stratification factors (nomogram score, ECOG PS, prior cabazitaxel use, BSC alone) as covariates. LSM, SE, LSM differences with 95% CIs, and p-values will be reported.
Baseline and Day 1 of each cycle during treatment
Biochemical Response - Best PSA Response Rate (best PSA-RR)
大体时间：Up to 36 months

Best prostate-specific antigen response rate (best PSA-RR) is defined as the proportion (%) of subjects with a ≥50% reduction in Prostate-Specific Antigen (PSA) levels from baseline.

Frequencies and percentages for each treatment group will be presented. Between-group comparisons will be performed using a stratified logistic regression model, adjusting for stratification factors (nomogram score [>178 vs. ≤178], ECOG performance status [0-1 vs. 2], prior cabazitaxel use, and best supportive care alone). The odds ratio (OR) for the treatment group relative to the control group, along with its two-sided 95% confidence interval (CI) and corresponding p-value, will be reported.
Up to 36 months
Health-Related Quality of Life (HRQoL) - FACT-P (Functional Assessment of Cancer Therapy - Prostate)
大体时间：Baseline and Day 1 of each cycle during treatment

Evaluated using Functional Assessment of Cancer Therapy - Prostate (FACT-P) total score (27-item FACT-General plus 12-item Prostate Cancer Subscale). Total scores range from 0 to 156, with higher scores indicating better quality of life. Questionnaire is completed prior to IP administration on Day 1 of each cycle.

Summary statistics (N, mean, SD, median, min, max) for baseline and post-baseline will be reported. Between-group comparisons will be analyzed using ANCOVA on change from baseline, with treatment group as a fixed effect, and baseline score and stratification factors (nomogram score [>178 vs. ≤178], ECOG PS [0-1 vs. 2], prior cabazitaxel use, and best supportive care alone) as covariates. LSM, SE, LSM differences with 95% CIs, and p-values will be reported.
Baseline and Day 1 of each cycle during treatment
Biochemical Response - Changes in LDH (Lactate Dehydrogenase)
大体时间：Baseline and scheduled study visits up to 36 months

Evaluated by the change from baseline in serum lactate dehydrogenase (LDH) level at specified time points.

Summary statistics (N, mean, SD, median, min, max) for baseline and post-baseline will be reported. Between-group comparisons will be analyzed using ANCOVA on change from baseline, with treatment group as a fixed effect, and baseline LDH level and stratification factors (nomogram score [>178 vs. ≤178], ECOG PS [0-1 vs. 2], prior cabazitaxel use, and best supportive care alone) as covariates. LSM, SE, LSM differences with 95% CIs, and p-values will be reported.
Baseline and scheduled study visits up to 36 months
Biochemical Response - Changes in ALP (Alkaline Phosphatase)
大体时间：Baseline and scheduled study visits up to 36 months

Evaluated by the change from baseline in serum alkaline phosphatase (ALP) level at specified time points.

Summary statistics (N, mean, SD, median, min, max) for baseline and post-baseline will be reported. Between-group comparisons will be analyzed using ANCOVA on change from baseline, with treatment group as a fixed effect, and baseline ALP level and stratification factors (nomogram score [>178 vs. ≤178], ECOG PS [0-1 vs. 2], prior cabazitaxel use, and best supportive care alone) as covariates. LSM, SE, LSM differences with 95% CIs, and p-values will be reported.
Baseline and scheduled study visits up to 36 months
Disease Control Rate (DCR)
大体时间：Up to 36 months

Disease Control Rate (DCR) is defined as the proportion (%) of subjects who achieved Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Assessments are performed according to RECIST v1.1, PCWG3-modified RECIST v1.1, and RECIP 1.0 by both Independent Central Review (BICR) and Investigator, except for RECIP 1.0 which is evaluated by BICR only.

Frequencies, percentages, and two-sided 95% confidence intervals (CIs) for each treatment group will be presented. Between-group comparisons will be performed using a stratified logistic regression model, adjusting for stratification factors (nomogram score [>178 vs. ≤178], ECOG PS [0-1 vs. 2], prior cabazitaxel use, and best supportive care alone). The odds ratio (OR) for the treatment group relative to the control group, along with its two-sided 95% CI and corresponding p-value, will be reported.
Up to 36 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

FutureChem

调查人员

  • 首席研究员：Ji Youl Lee、Seoul St. Mary's Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年1月26日

初级完成 (估计的)

2028年3月26日

研究完成 (估计的)

2029年1月26日

研究注册日期

首次提交

2026年4月15日

首先提交符合 QC 标准的

2026年9月28日

首次发布 (实际的)

2026年10月1日

研究记录更新

最后更新发布 (实际的)

2026年10月1日

上次提交的符合 QC 标准的更新

2026年9月28日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • FC705-3

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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