177Lu-PSMA-617 Combined With Darolutamide in Neoadjuvant Treatment of High-risk Localized Prostate Cancer: a Prospective, Single-arm, Multi-center Clinical Trial (IUNU-PC-123)
2026年6月24日 更新者：Hongqian Guo、The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
The goal of this clinical trial is to explore the efficacy and safety of darolutamide combined with 177Lu-PSMA-617 in treating high-risk localized prostate cancer patients who are scheduled to undergo radical prostatectomy. The main questions it aims to answer are:
Does this combination treatment improve the pathological complete response rate (pCR)? What is the minimal residual disease (MRD) rate in these patients? What are the safety profiles and any adverse effects associated with this treatment? Researchers will compare the combination of darolutamide and 177Lu-PSMA-617 to a placebo to see if the combination is effective in treating high-risk localized prostate cancer.
Participants will:
Receive either darolutamide combined with 177Lu-PSMA-617 or a placebo every day for 12 weeks.
Visit the clinic every 6 weeks for checkups and tests. Keep a diary of their symptoms and any side effects experienced during the treatment.
Undergo imaging tests, including prostate MRI and PSMA PET/CT, before surgery and during follow-up.
調査の概要
研究の種類
介入
入学 (推定)
20
段階
- フェーズ 4
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
- 名前：Hongqian Guo
- 電話番号：+86 (025)-83106666
- メール：dr.ghq@nju.edu.cn
研究場所
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Jiangsu
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Nanjing、Jiangsu、中国
- Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
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コンタクト：
- Hongqian Guo
- 電話番号：+86 (025)-83106666
- メール：dr.ghq@nju.edu.cn
-
-
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
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Patients must be ≥ 18 and ≤75 years of age
- All patients must have a histologically or cytologically diagnosis of prostate cancer，without distant metastasis, and suitable for radical prostatectomy
- All patients meet at least one of the following criteria： multi-parameter MRI or PSMA PET / CT shows clinical staging of primary tumor ≥ T2c； Gleason score of primary tumor ≥ 8； prostate specific antigen (PSA) ≥20 ng/ml； Radiographic assessment of regional lymph node metastases (N1)
- Eastern Cooperative Oncology Group (ECOG) physical condition score 0- 1
- Primary lesion SUVmax ≥ 20.0 as assessed by PSMA-PET examination.
- Adequate organ function: Complete Blood Count: White blood cell count (WBC) ≥ 3.0 × 10^9/L, platelet count ≥ 100 × 10^9/L, hemoglobin ≥ 9 g/dL. Renal Function: Serum creatinine ≤ 2 × ULN. Liver Function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN, total bilirubin (TBIL) ≤ 1.5 × ULN. Coagulation Function: International normalized ratio (INR) < 1.5.
- Voluntary Participation: Participants must voluntarily agree to participate and sign the informed consent form (ICF), indicating their understanding of the purpose of the study and the required procedures, as well as their willingness to participate in the research. Participants must be willing to comply with the prohibitions and restrictions outlined in the study protocol.
- Patients of childbearing potential must be willing to take high-efficiency contraceptive measures during the study period and within 120 days after the last dose of treatment
Exclusion Criteria:
- Patients with prostate having neuroendocrine, small cell, or sarcoma-like features are not eligible
- Patients with low-risk and medium-risk, localized prostate cancer (the following conditions are met at the same time) are not eligible: prostate specific antigen (PSA) <20 ng/mL multiparameter MRI or PSMA PET / CT shows clinical staging of primary tumor < T3, Gleason score of primary tumor < 8
- Patients with clinical or radiological evidence of regional or extra-regional lymph node metastases or bone metastases or visceral metastases (any M1）
- Primary lesion SUVmax < 20.0 as assessed by PSMA-PET examination.
- Patients who have previously received androgen deprivation therapy (medical or surgical) more than 3 months or focal treatment of prostate cancer or prostate cancer radiotherapy or prostate cancer chemotherapy
- Patients with severe or uncontrolled concurrent infections
- Patients must not have New York Heart Association Class III or IV congestive heart failure at the time of screening. Patients must not have any thromboembolic event, unstable angina pectoris, myocardial infarction within 6 months prior to registration
- Uncontrolled severe hypertension, persistently uncontrolled diabetes, oxygen-dependent lung disease, chronic liver disease, or HIV infection
- Patients with a history of other malignancies within the past 5 years, except for prostate cancer, are not eligible; however, cured basal cell carcinoma or squamous cell carcinoma of the skin may be eligible
- Patients with mental illness, mental disability, or inability to provide informed consent
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：なし
- 介入モデル：単一グループの割り当て
- 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 |
|---|---|
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実験的：実験アーム
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177Lu-PSMA-617: Eligible participants must start receiving 177Lu-PSMA-617 within 14 days. Participants will receive a dosage of 7.4 GBq (± 10%) of 177Lu-PSMA-617, administered once every 6 weeks (± 7 days), for a total of two doses. Darolutamide: Administered at a dosage of 1200 mg orally in two divided doses with meals, starting from the first injection of 177Lu-PSMA-617 and continuing until 6 weeks after the second injection, for a total duration of 12 weeks. |
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 |
|---|---|---|
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pCR + MRD
時間枠：Screening, End of Neoadjuvant Treatment( 12 weeks after baseline)
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pCR + MRD (pCR: Pathological Complete Response; Minimal Residual Disease (MRD) rate: defined as the proportion of patients achieving MRD among all patients; MRD is defined as postoperative pathology indicating that the longest diameter of the tumor is ≤ 5 mm)
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Screening, End of Neoadjuvant Treatment( 12 weeks after baseline)
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Patient Sexual Function
時間枠：Day 1 of Cycle 1&2 ( each cycle is 6 weeks), 1 month after treatment, 3 and 6 months after treatment, 6 months until 2 years
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The International Index of Erectile Function (IIEF-5) will be used for assessment.
This scale consists of five questions, with each question scored from 0 to 5, resulting in a total score range of 0 to 25.
A total score greater than 21 indicates normal erectile function; a score of 12 to 21 indicates mild erectile dysfunction; a score of 8 to 11 indicates moderate erectile dysfunction; and a score of 1 to 7 indicates severe erectile dysfunction.
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Day 1 of Cycle 1&2 ( each cycle is 6 weeks), 1 month after treatment, 3 and 6 months after treatment, 6 months until 2 years
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PSA Response Rate (defined as a decrease in PSA of 50% or more)
時間枠：Day 1 of Cycle 1&2 (each cycle is 6 weeks), End of Neoadjuvant Treatment (12 weeks after baseline). The last week of each month for the first 3 months after the periprocedural, thereafter the last week of every 3rd month for a total duration of 1 year
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Day 1 of Cycle 1&2 (each cycle is 6 weeks), End of Neoadjuvant Treatment (12 weeks after baseline). The last week of each month for the first 3 months after the periprocedural, thereafter the last week of every 3rd month for a total duration of 1 year
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PSMA Response Rate
時間枠：Screening, End of Neoadjuvant Treatment (12 weeks after baseline)
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PSMA Response Rate: The assessment of PSMA response will be conducted using PSMA PET/CT at 6 weeks after treatment with 177Lu-PSMA-617.
If all PSMA lesions have disappeared, it is classified as PSMA complete response.
If the SUVmax (maximum standardized uptake value) decreases by more than 30%, it is classified as partial response.
If the SUVmax increases by more than 30% or new PSMA-avid lesions appear, it is classified as disease progression.
If the response does not meet the criteria for complete response, partial response, or disease progression, it is classified as stable disease.
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Screening, End of Neoadjuvant Treatment (12 weeks after baseline)
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1-year biochemical recurrence-free survival, bRFS
時間枠：The last week of each month for the first 3 months after the periprocedural, thereafter the last week of every 3rd month for a total duration of 1 year
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1-year Biochemical Recurrence-Free Survival (bRFS): Biochemical recurrence is defined as the occurrence of PSA levels exceeding 0.2 ng/ml in two consecutive tests after radical prostatectomy, with no evidence of recurrence or metastasis on imaging.
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The last week of each month for the first 3 months after the periprocedural, thereafter the last week of every 3rd month for a total duration of 1 year
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Perioperative Complications
時間枠：Perioperative Period
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Perioperative Period
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Patient Quality of Life
時間枠：Day 1 of Cycle 1&2 ( each cycle is 6 weeks), 1 month after treatment, 3 and 6 months after treatmnet,6 months until 2 years
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The FACT-P scale (39 items) will be used for assessment.
This scale includes a general functional status scale (composed of four subscales: physical, social and family, emotional, and functional) and a prostate cancer-specific subscale.
The total score is calculated from the general functional and prostate cancer-specific scores, with a range from 0 to 156; a higher score indicates better functional status.
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Day 1 of Cycle 1&2 ( each cycle is 6 weeks), 1 month after treatment, 3 and 6 months after treatmnet,6 months until 2 years
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Tumor Radiation Absorbed Dose: The maximum absorbed dose of 177Lu-PSMA-617 treatment for the prostate (measured in Gray [Gy])
時間枠：Screening, End of Neoadjuvant Treatment(12 weeks after baseline)
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Screening, End of Neoadjuvant Treatment(12 weeks after baseline)
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Adverse Event
時間枠：From Day 1 of cycle 1 to the 30 days after study completion, an average of 1year and 4 months.
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All adverse events (AEs) will be assessed and graded according to NCI-CTCAE v5.0.
Safety evaluations will be conducted and recorded after the initiation of the study drug, regardless of their relationship to the study drug, until 30 days after the last study treatment or the start of new anticancer therapy (whichever occurs first).
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From Day 1 of cycle 1 to the 30 days after study completion, an average of 1year and 4 months.
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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。
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 (推定)
2026年7月1日
一次修了 (推定)
2027年7月1日
研究の完了 (推定)
2028年12月31日
試験登録日
最初に提出
2026年6月18日
QC基準を満たした最初の提出物
2026年6月24日
最初の投稿 (実際)
2026年7月1日
学習記録の更新
投稿された最後の更新 (実際)
2026年7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6月24日
最終確認日
2026年6月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。