Therapeutic Efficiency and Response to 2.0 GBq (55mCi) 177Lu-EB-PSMA in Patients With mCRPC
2022年7月13日 更新者：Peking Union Medical College Hospital
In recent years, quite a few studies have demonstrated the possibility of 177Lu-PSMA-617 therapy as a viable treatment option in metastatic castration resistant prostate cancer (mCRPC), which has been shown desired effect.
To increase tumor accumulation and retention for radioligand therapy, and reduce dosage of 177Lu, we conjugated a truncated Evans blue (EB) molecule and DOTA chelator onto PSMA-617 (EB-PSMA) and labeled it with 177Lu.
This study is designed to assess the efficiency and response to 177Lu-EB-PSMA (55 mCi) in patients with mCRPC.
調査の概要
詳細な説明
Prostate cancer is one of the most common cancers and the second most frequent cause of cancer deaths for adult men.
With the advances in the diagnosis and treatment of prostate cancer, some patients with localized prostate cancer can achieve good curative results, but there are still 10%～20% of patients progress to metastatic castration-resistant prostate cancer (mCRPC) every year, only one third of patients with mCRPC survive more than five years.
Radioligand therapy targeting prostate specific membrane antigen (PSMA), which is overexpressed in most prostate cancer and even further increased in metastatic and castration-resistant carcinomas, has been demonstrated as an effective and safe therapy in men with mCRPC.
177Lu-PSMA-617 has also shown desired effect.
However, 177Lu-PSMA-617, as a small molecule imaging agent, is cleared very quickly from the circulation.
Therefore, radiotherapy that is based on small molecules requires high doses and frequent administrations, leading to systemic toxicity.
To increase tumor accumulation and retention for radioligand therapy, and reduce dosage of 177Lu, the investigators conjugated a truncated Evans blue (EB) molecule and DOTA chelator onto PSMA-617 (EB-PSMA) and labeled it with 177Lu.
The investigators have published some articles demonstrated 177Lu-EB-PSMA had much higher accumulation in prostate cancer lesions than 177Lu-PSMA-617 and also showed an ideal effect.
This study is designed to assess the efficiency and response to 177Lu-EB-PSMA (55 mCi) in patients with mCRPC.
研究の種類
介入
入学 (予想される)
30
段階
- 初期フェーズ 1
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。
研究場所
-
-
Beijing
-
Beijing、Beijing、中国、100730
- 募集
- Peking Union Medical College Hospital
-
-
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
18年～90年 (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:
- All the patients had progressive metastatic castration-resistant prostate cancer that did not respond to androgen-suppression therapy and/or systemic chemotherapy;
- Distant metastases with high PSMA expression were confirmed on 68Ga-PSMA PET/CT within one week before the injection of 177Lu-EB-PSMA.
Exclusion Criteria:
- The exclusion criteria were a serum creatinine level of more than 150 μmol per liter, a hemoglobin level of less than 10.0 g/dl, a white-cell count of less than 4.0× 109/L, a platelet count of less than 100 × 109/L, a total bilirubin level of more than 3 times the upper limit of the normal range and a serum albumin level of more than 3.0 g per deciliter, cardiac insufficiency including carcinoid heart valve disease, a severe allergy or hypersensitivity to radiographic contrast material, claustrophobia.
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 |
|---|---|
|
実験的：2.0 GBq of 177Lu-EB-PSMA
The patients were intravenously injected with the dose about 2.0 GBq (55 mCi) of 177Lu-EB-PSMA and underwent 68Ga-PSMA PET/CT scans before and after the treatment.
|
Patients were intravenous administrated with the dose about 2.0 GBq (55 mCi) of 177Lu-EB-PSMA every 8 weeks (±1 week) for a maximum of 3 cycles.
|
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 |
|---|---|---|
|
Therapeutic effect: PSA Response
時間枠：through study completion, an average of 1 month
|
The serum PSA response was documented monthly until 8 weeks after the last treatment therapy, which can effectively reflect the treatment effect of prostate cancer.
Biochemical response was classified as the following: partial response (PR) if PSA decrease ≥50%, progressive disease (PD) if PSA increase ≥ 25% and stable disease (SD) if PSA increase <25% or PSA decrease <50%.
|
through study completion, an average of 1 month
|
|
Therapeutic effect: 68Ga-PSMA PET/CT Response
時間枠：through study completion, an average of 2 months
|
68Ga-PSMA-617 wholebody PET/CT acquisitions 8 weeks after each cycle of treatment.
The molecular response was classified according to adapted modified PERSIST 1.0 criteria.
Complete response (CR) was complete resolution of 68Ga-PSMA-617 uptake in the target lesions.
Partial response (PR) was defined as ≥30% decrease in the SUVmax of the target lesions and total Lesions PSMA from the baseline scan, and ≥ 30% increase in the SUVmax value of the target lesions and total Lesions PSMA from the baseline scan was taken as progressive disease (PD).
Neither CR, PR nor PD was considered stable disease (SD) that was <30% decrease or <30% increase of the target lesion.
Changes of SUV (ΔSUV) between pre- and post-therapeutic PET were calculated.
|
through study completion, an average of 2 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Adverse events collection: Blood tests
時間枠：through study completion, an average of 1 month
|
Blood tests including hematologic status, liver function, and renal function were performed before and every two weeks after each cycle of treatment for a period of 8 weeks.
Adverse events were categorized using the Common Toxicity Criteria for Adverse Events 5.0.
|
through study completion, an average of 1 month
|
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 (実際)
2019年1月14日
一次修了 (予想される)
2022年9月1日
研究の完了 (予想される)
2022年12月1日
試験登録日
最初に提出
2021年7月22日
QC基準を満たした最初の提出物
2021年7月30日
最初の投稿 (実際)
2021年8月9日
学習記録の更新
投稿された最後の更新 (実際)
2022年7月15日
QC基準を満たした最後の更新が送信されました
2022年7月13日
最終確認日
2022年7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。