Effects of Direct Artery Injection on Prostate Cancer Drug Delivery and Tumor Uptake: Imaging-Based Prediction of Treatment Effectiveness (IAPSMA)
Impact of Intra-Arterial PSMA Injection on Distribution and Tumor Uptake: Texture Analysis and Dose Radicality Prediction in Prostate Cancer
The goal of this clinical trial is to learn whether intra-arterial (IA) administration of 68Ga-PSMA improves tumor uptake and distribution compared with standard intravenous (IV) administration in patients with localized high-risk prostate cancer. The study will also evaluate the safety of the IA procedure and investigate whether advanced PET/CT imaging features can help predict the radiation dose needed for future personalized 177Lu-PSMA radioligand therapy.
The main questions it aims to answer are:
- Does intra-arterial 68Ga-PSMA administration result in higher and more homogeneous tumor uptake than standard intravenous administration?
- Can PET/CT texture analysis and dosimetric modeling predict the radiation dose required to achieve a curative effect with 177Lu-PSMA therapy?
- What radiation exposure and procedure-related risks are associated with intra-arterial administration for patients and medical staff?
Researchers will compare PSMA uptake and distribution after intravenous and intra-arterial administration of 68Ga-PSMA using PET/CT imaging.
Participants will:
- Undergo a standard intravenous 68Ga-PSMA PET/CT scan.
- Undergo a second 68Ga-PSMA PET/CT scan following selective intra-arterial administration through the prostatic artery.
- Have imaging data analyzed using advanced texture analysis and voxel-based dosimetry methods.
- Undergo radical prostatectomy according to standard clinical care, with pathological analysis of surgical specimens.
- Be monitored for adverse events, radiation exposure, and procedural safety throughout the study.
調査の概要
詳細な説明
PSMA-targeted radioligands have become an important tool for imaging and treatment of prostate cancer. Intravenous (IV) administration is the current standard route of administration; however, intra-arterial (IA) delivery through the prostatic artery may increase local radioligand concentration within the tumor while reducing systemic distribution.
This prospective, single-center, interventional study aims to evaluate the effect of IA administration of 68Ga-PSMA on tracer distribution and tumor uptake in patients with localized high-risk prostate cancer undergoing radical prostatectomy.
Participants will undergo standard-of-care 68Ga-PSMA PET/CT imaging following intravenous administration and a second PET/CT examination following selective intra-arterial administration of 68Ga-PSMA through the prostatic artery. Quantitative PET/CT analysis will be used to compare tumor uptake, tumor-to-background ratios, and intratumoral distribution between the two administration routes.
The study will also establish and evaluate a standardized technique for selective prostatic artery catheterization and IA radioligand administration. Procedural feasibility, technical success, adverse events, and radiation exposure to patients and medical personnel will be assessed.
Advanced radiomic texture analysis and voxel-based dosimetry will be performed on PET/CT datasets to characterize intratumoral heterogeneity and investigate imaging biomarkers associated with radiotracer distribution. These data will be used to develop predictive models estimating the radiation dose required to achieve a curative ("radical") effect with future 177Lu-PSMA radioligand therapy.
Following imaging, participants will undergo radical prostatectomy according to standard clinical practice. Histopathological findings will be correlated with imaging-derived uptake and texture parameters.
The study is designed to determine whether IA administration improves PSMA uptake and distribution compared with IV administration and to explore imaging-based approaches for personalized radioligand therapy planning in localized prostate cancer.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Donatas Vajauskas, Professor
- 電話番号：+37068750906
- メール：donatas.vajauskas@lsmu.lt
研究連絡先のバックアップ
- 名前：Rūta Dubeikaitė
- 電話番号：+37062266019
- メール：ruta.dubeikaite@lsmu.lt
研究場所
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Kaunas、リトアニア、LT-50103
- Lithuanian University of Health Sciences Kaunas Clinics
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コンタクト：
- Administrator
- 電話番号：+3703770337
- メール：rastine@kaunoklinikos.lt
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参加基準
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
説明
Inclusion Criteria:
- Adult male patients with biopsy-proven prostate adenocarcinoma up to stages ≤T3bN1 by initial preoperative examination, with no distant metastases (M0) on ⁶⁸Ga-PSMA PET/CT.
- Systemic therapy-naive patients scheduled for radical prostatectomy with/without pelvic lymph node dissection with curative intent.
High-risk localized or locally-advanced prostate cancer according to European Association of Urology criteria, including one of the following:
- Prostate-specific antigen > 20ng/mL2 or ISUP grade 4/5.
- Clinical T stage cT3-4* and/or N1 disease (involvement of lymph nodes at or below the bifurcation of the common iliac arteries), any ISUP grade, and any
- High PSMA avidity on ⁶⁸Ga-PSMA PET/CT, defined as SUVmax ≥20.
- Normal baseline hematological function.
- Normal serum biochemistry.
- Signed informed consent form.
Exclusion Criteria:
- Patients with other (non-adenocarcinoma) biopsy-proven histology of prostate cancer.
Patients with low-risk prostate cancer according to European Association of Urology criteria, including any of the following:
- Prostate-specific antigen <10 ng/ml.
- International Society of Urological Pathology grade group 1.
- Clinical T stage T1-T2a digital rectal examination.
- Prior radiotherapy or systemic therapy for prostate cancer.
- Prostate cancer with low PSMA avidity (SUVmax <20) on ⁶⁸Ga-PSMA PET/CT.
- Evidence of distant metastatic spread (M1) on ⁶⁸Ga-PSMA PET/CT.
- Contraindications for radical prostatectomy.
- Major comorbidities and laboratory abnormalities that might confound the results of the trial or interfere with the patient's ability to participate.
- Refusal to participate in the trial.
研究計画
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：診断
- 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：IA-PSMA
All enrolled participants receive the same sequence of interventions:
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Additional intervention to the standard of care for prostate cancer treatment - prostate artery catheterization and intra-arterial injection of 68Ga-PSMA with subsequent PET/CT scan.
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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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Relative increase in intratumoral PSMA uptake after intra-arterial versus intravenous ⁶⁸Ga-PSMA administration
時間枠：Up to 6 weeks from enrollment.
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To determine whether selective intra-arterial (IA) administration of ⁶⁸Ga-PSMA results in superior tumor targeting compared with standard intravenous (IV) administration.
Uptake will be quantified using PET/CT-derived parameters, including SUVmax, SUVmean, tumor-to-background ratio (TBR), and volumetric uptake metrics obtained from paired IV and IA scans performed in the same patient.
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Up to 6 weeks from enrollment.
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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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Technical success rate of selective intra-arterial prostate artery catheterization
時間枠：Up to 6 weeks from enrollment.
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To evaluate the feasibility and reproducibility of the developed IA delivery protocol by assessing successful selective catheterization of the target prostatic artery and completion of radiotracer administration according to protocol.
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Up to 6 weeks from enrollment.
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Procedural safety of intra-arterial PSMA administration
時間枠：From IA administration until radical prostatectomy at up to 3 months from enrollment.
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To assess the safety profile of IA radioligand administration, including procedure-related complications and adverse events.
Number, type, and severity of adverse events graded according to CTCAE v5.0; incidence of vascular complications, non-target administration, bleeding, infection, or other procedure-related events
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From IA administration until radical prostatectomy at up to 3 months from enrollment.
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Patient and operator radiation exposure during intra-arterial versus intravenous procedures
時間枠：Up to 6 weeks from enrollment.
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To compare the radiation burden associated with IA and IV administration pathways.
Absorbed radiation dose (mSv) derived from measurement during and after the procedure.
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Up to 6 weeks from enrollment.
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Identification of PET texture biomarkers associated with optimal tumor saturation
時間枠：Up to 1 year from enrollment.
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To identify radiomic features predictive of favorable intratumoral radiotracer distribution and complete lesion saturation.
Association between extracted texture features and dosimetric endpoints using regression and machine-learning analyses.
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Up to 1 year from enrollment.
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Predicted absorbed tumor dose achievable with ¹⁷⁷Lu-PSMA therapy
時間枠：Up to 1 year from enrollment.
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To estimate the radiation dose that would be delivered to tumor tissue during therapeutic ¹⁷⁷Lu-PSMA administration based on diagnostic PET-derived biodistribution.
Voxel-based absorbed dose estimates (Gy) and dose-volume histogram parameters.
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Up to 1 year from enrollment.
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協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- PSMA 1.0
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?
IPD プランの説明
IPD 共有時間枠
IPD 共有サポート情報タイプ
- ICF
- CSR
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
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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。
前立腺がんの臨床試験
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Novartis Pharmaceuticals終了しましたメラノーマ | 高度なEGFR変異体非小さな細胞肺cancer（NSCLC） | KRAS G12変異NSCLC | 食道扁平上皮がん（SCC） | ヘッド/ネックSCC | 進行した胃腸間質腫瘍（GIST） | 進行したNRAS/BRAFT WT皮膚黒色腫アメリカ, 台湾, オランダ, カナダ, スペイン, シンガポール, イタリア, 日本, 韓国
-
Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI); Highlight Therapeutics積極的、募集していない平滑筋肉腫 | 悪性末梢神経鞘腫瘍 | 滑膜肉腫 | 未分化多形肉腫 | 骨の未分化高悪性度多形肉腫 | 粘液線維肉腫 | II期の体幹および四肢の軟部肉腫 AJCC v8 | III期の体幹および四肢の軟部肉腫 AJCC v8 | IIIA 期の体幹および四肢の軟部肉腫 AJCC v8 | IIIB 期の体幹および四肢の軟部肉腫 AJCC v8 | 切除可能な軟部肉腫 | 多形性横紋筋肉腫 | 切除可能な脱分化型脂肪肉腫 | 切除可能な未分化多形肉腫 | 軟部組織線維肉腫 | 紡錘細胞肉腫 | ステージ I 後腹膜肉腫 AJCC (American Joint Committee on Cancer) v8 | 体幹および四肢の I 期軟部肉腫 AJCC v8 | ステージ... およびその他の条件アメリカ
Intraarterial injection of 68Ga-PSMAの臨床試験
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Shanghai General Hospital, Shanghai Jiao Tong University...NanoMab Technology (UK) Limited完了
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First Affiliated Hospital of Fujian Medical University募集
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German Cancer Research CenterUniversity Hospital Freiburg; ABX CRO; Friedrich-Alexander-Universität Erlangen-Nürnberg完了
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Chengdu StarRay Therapeutics Co., Ltdまだ募集していません転移性去勢抵抗性前立腺がん (mCRPC)
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Anhui Provincial Hospital募集
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Peking Union Medical College Hospital募集