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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.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

114

段階

  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • 韓国
      • Gyeonggi-do、韓国
        • 募集
        • National Cancer Center
        • コンタクト：
      • Seoul、韓国
        • 募集
        • Samsung Medical Center
        • コンタクト：
      • Seoul、韓国
        • 募集
        • Seoul National University Hospital
        • コンタクト：
      • Seoul、韓国
        • 募集
        • Severance Hospital
        • コンタクト：
          • Seung Hwan Lee
          • 電話番号：82 2 1599 1004
          • メール：LEESEH@yuhs.ac
      • Seoul、韓国
        • 募集
        • Seoul St. Mary's Hospital
        • コンタクト：
      • Seoul、韓国
        • 募集
        • Ewha Woman University Medical Center
        • コンタクト：
      • Seoul、韓国
        • まだ募集していません
        • Korea University ANAM Hospital
        • コンタクト：
      • Suwon、韓国
        • 募集
        • St. Vincent's Hospital
        • コンタクト：

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

19年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

男

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：クロスオーバー割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：[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.
薬：[177-Lu]Ludotadipep

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

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

Best supportive care/standard of care as defined by the investigator.
アクティブコンパレータ：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.
他の：Best supportive care/standard of care (BSC/SOC) alone

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

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Radiographic Progression-Free Survival (rPFS)
時間枠：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.

二次結果の測定

結果測定
メジャーの説明
時間枠
Radiographic Progression-Free Survival (rPFS)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

FutureChem

捜査官

  • 主任研究者：Ji Youl Lee、Seoul St. Mary's Hospital

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年1月26日

一次修了 (推定)

2028年3月26日

研究の完了 (推定)

2029年1月26日

試験登録日

最初に提出

2026年4月15日

QC基準を満たした最初の提出物

2026年9月28日

最初の投稿 (実際)

2026年10月1日

学習記録の更新

投稿された最後の更新 (実際)

2026年10月1日

QC基準を満たした最後の更新が送信されました

2026年9月28日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • FC705-3

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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