パーソナライズされたvs.固定活動177LU-PSMA-617放射性医薬品療法（Prodigy-2） (PRODIGY-2)
前立腺特異的膜抗原線量測定誘導性エンドラジオ療法：パーソナライズされた有効性と固定活動の無作為化制御、単一盲検パイロット研究177LU-PSMA-617放射性医薬品療法（Prodigy-2）
The goal of this clinical trial is to assess if a personalized regime of 177Lu-PSMA-617 (Lutetium Lu 177 vipivotide tetraxetan, also known as Pluvicto) is feasible and safe in a population of patients with metastatic castrate-resistant prostate cancer (mCRPC). The main questions it aims to answer are:
- Can the administered activity (cumulative or per-cycle) be increased in a majority of participants?
- What is the incidence of some specific adverse reactions during the treatment?
Researchers will compare participants receiving a personalized regime to participants receiving the standard fixed-activity regime of 177Lu-PSMA-617 to see if the activity can be safely increased through personalization based on renal dosimetry (i.e. the measure of how much radiation is actually delivered to the kidney).
Participants will receive up to 6 treatments of 177Lu-PSMA-617 every 6 weeks and be regularly evaluated with imaging and laboratory tests, as well as with questionnaires.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- フェーズ 1
連絡先と場所
研究連絡先
研究連絡先
- 名前：Marie-Christine Dubé, Ph.D.
- 電話番号：418-525-4444
- メール：marie-christine.dube@crchudequebec.ulaval.ca
研究場所
-
-
Quebec
-
Québec、Quebec、カナダ、G1R2J6
- 募集
- CHU de Québec-Université Laval
-
コンタクト：
- Marie-Christine Dubé, Ph.D.
- 電話番号：418-525-4444
- メール：marie-christine.dube@crchudequebec.ulaval.ca
-
主任研究者：
- Jean-Mathieu Beauregard, MD
-
-
参加基準
適格基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Patient aged ≥18 years with metastatic adenocarcinoma of the prostate, defined by documented histopathology of prostate adenocarcinoma;
- Castration-resistant prostate cancer, as defined as disease progressing despite castration by orchiectomy or ongoing androgen deprivation therapy (serum testosterone level ≤ 1.7 nmol/dL within 60 days from first cycle);
- Biochemically progressive mCRPC with rising PSA level, defined by PCWG3 criteria (sequence of two rising values above a baseline at a minimum of 1-week intervals, with the second of these within 60 days from first cycle);
- PSA ≥2 ng/mL ;
- Prior treatment with at least one ARPI;
- PSMA-expressing cancer, with significant PSMA expression defined as SUVpeak in at least one lesion that is superior to SUVmean of the liver on PSMA-PET (68Ga-PSMA-11 or 18F-DCFPyL), within 45 days prior to randomization;
- ECOG Performance status 0 to 2;
- Calculated eGFR (by CKD-EPI formula) ≥ 45 mL/min/1.73m^2;
- Albumin ≥ 25 g/L;
- Platelets ≥ 100x10^9/L;
- Neutrophils ≥ 1.5x10^9/L;
- Hemoglobin ≥ 90 g/L without transfusion in the past 4 weeks;
- Signed, written informed consent
Exclusion Criteria:
- PSMA-PET "superscan" (i.e. extensive/diffuse PSMA-positive bone involvement);
- Site(s) of disease that are FDG-positive, defined as SUVpeak in at least one lesion that is superior to twice (2x) SUVmean of the liver, and PSMA-negative (as above), within 45 days prior to randomization;
- Prior treatment with more than two lines of chemotherapy for mHSPC and/or mCRPC (a line is counted if at least 2 cycles were administered; adjuvant and neoadjuvant chemotherapy does not count towards the maximum of two lines);
- Prior PSMA-directed radiopharmaceutical therapy (radium-223 is allowed);
- Known CNS metastasis unless they are deemed to be non-progressive, asymptomatic and off corticosteroid therapy for at least four weeks, as per investigator's assessment;
- Active malignancy other than prostate cancer;
- Patients who are sexually active and not willing/able to use medically acceptable forms of barrier contraception;
- Any other condition, diagnosis or finding that may in the investigator's opinion interfere with trial conduct;
- Known hypersensitivity to 177Lu-PSMA-617 or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
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：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的：パーソナライズされたアクティビティ
|
6 cycles of personalized activity (1st cycle based on BSA and eGFR; cycles 2-6 based on renal dosimetry), maximum 22.2 GBq, every 6 weeks 6 cycles of 7.4 GBq every 6 weeks |
|
アクティブコンパレータ：固定アクティビティ
|
6 cycles of personalized activity (1st cycle based on BSA and eGFR; cycles 2-6 based on renal dosimetry), maximum 22.2 GBq, every 6 weeks 6 cycles of 7.4 GBq every 6 weeks |
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Administered activity of 177Lu-PSMA-617
時間枠：From first administration to the end of treatment (each cycle is 6 weeks, up to 6 cycles)
|
In GBq, cumulative and average per cycle. |
From first administration to the end of treatment (each cycle is 6 weeks, up to 6 cycles)
|
|
Number of participants with subacute adverse events of special interest (AESIs)
時間枠：From first administration to the end of treatment (each cycle is 6 weeks, up to 6 cycles)
|
Subacute AESIs are:
|
From first administration to the end of treatment (each cycle is 6 weeks, up to 6 cycles)
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
BaselineでのEuroQOL-5 Dimension-5レベル（EQ-5D-5L）アンケートのスコアのバリエーション
時間枠：ベースライン、18週間、および治療の終了時（各サイクルは6週間、連続サイクルまで）
|
ベースライン、18週間、および治療の終了時（各サイクルは6週間、連続サイクルまで）
|
|
|
癌療法の機能的評価におけるスコアのバリエーション - ベースラインでの前立腺（ファクト-P）アンケート
時間枠：ベースライン、18週間、および治療の終了時（各サイクルは6週間、連続サイクルまで）
|
ベースライン、18週間、および治療の終了時（各サイクルは6週間、連続サイクルまで）
|
|
|
ベースラインでの短い痛みインベントリ（BPI-SF）アンケートのスコアのバリエーション
時間枠：ベースライン、18週間、および治療の終了時（各サイクルは6週間、連続サイクルまで）
|
ベースライン、18週間、および治療の終了時（各サイクルは6週間、連続サイクルまで）
|
|
|
学際的な唾液腺社会（MSGS）アンケートでのスコアのバリエーションベースラインでのアンケート
時間枠：ベースライン、18週間、および治療の終了時（各サイクルは6週間、連続サイクルまで）
|
ベースライン、18週間、および治療の終了時（各サイクルは6週間、連続サイクルまで）
|
|
|
Best biochemical response
時間枠：From first administration until 52 weeks or the start of another anti-cancer treatment or death, whichever is earliest
|
Maximum percent decrease of serum prostate-specific antigen (PSA) after first administration. |
From first administration until 52 weeks or the start of another anti-cancer treatment or death, whichever is earliest
|
|
PSA progression-free survival (PSA-PFS)
時間枠：From date of first administration until the date of PSA progression or of the start of another anti-cancer treatment or of death, whichever came first, assessed over a minimum of 60 months
|
Time from first administration to an increase in PSA greater than 25%, and greater than 2 ng/ml, above nadir, confirmed at least 3 weeks later. |
From date of first administration until the date of PSA progression or of the start of another anti-cancer treatment or of death, whichever came first, assessed over a minimum of 60 months
|
|
Radiological progression-free survival (rPFS)
時間枠：From date of first administration until the date of radiological progression or of the start of another anti-cancer treatment or of death, whichever came first, assessed over a minimum of 60 months
|
Time from first administration to the date of radiographic disease progression based on RECIST 1.1/PCWG3. |
From date of first administration until the date of radiological progression or of the start of another anti-cancer treatment or of death, whichever came first, assessed over a minimum of 60 months
|
|
Investigator-assessed overall PFS
時間枠：From date of first administration until the date of investigator-assessed progression or of the start of another anti-cancer treatment or of death, whichever came first, assessed over a minimum of 60 months
|
Time from first administration to the earliest of clinical (worsening of a patient's clinical status attributed to disease progression), biochemical or radiological progression considering all data (scheduled and unscheduled) available to the investigator. |
From date of first administration until the date of investigator-assessed progression or of the start of another anti-cancer treatment or of death, whichever came first, assessed over a minimum of 60 months
|
|
Time to first symptomatic skeletal event (SSE)
時間枠：From date of first administration until the date of first SSE or of the start of another anti-cancer treatment or of death, whichever came first, assessed over a minimum of 60 months
|
Time to first Symptomatic Skeletal Event (SSE) is defined as the time from first administration to the date of the SSE. The SSE date is the date of first new symptomatic pathological bone fracture, spinal cord compression, tumor-related orthopedic surgical intervention, requirement for radiation therapy to relieve bone pain, or death due to any cause, whichever occurred first. |
From date of first administration until the date of first SSE or of the start of another anti-cancer treatment or of death, whichever came first, assessed over a minimum of 60 months
|
|
Overall survival (OS)
時間枠：From date of first administration until the date of death, assessed over a minimum of 60 months
|
Overall Survival (OS) is defined as the time from the date of the first administration to the date of death due to any cause. |
From date of first administration until the date of death, assessed over a minimum of 60 months
|
|
Metabolic response on FDG-PET/CT
時間枠：At baseline and at 12 weeks
|
Metabolic response is defined as complete metabolic response (CMR, disappearance of all lesions on FDG PET), partial metabolic response (PMR, decrease of uptake by ≥30%), stable metabolic disease (SMD, variation of FDG uptake by <30%), progressive metabolic disease (PMD, increase of FDG uptake by ≥30%) |
At baseline and at 12 weeks
|
|
Molecular response on PSMA-PET/CT
時間枠：At baseline and at the end of treatment (each cycle is 6 weeks, up to 6 consecutive cycles)
|
Molecular response is defined as the variation of molecular tumor volume (MTV) on PSMA-PET/CT |
At baseline and at the end of treatment (each cycle is 6 weeks, up to 6 consecutive cycles)
|
|
Best molecular response on quantitative 177Lu SPECT/CT during treatment
時間枠：From first cycle's Day 3 until the last cycle's Day 3 (each cycle is 6 weeks, up to 6 consecutive cycles)
|
Best molecular response is defined as the maximum percent decrease of molecular tumor volume (MTV) at any time after post-treatment quantitative 177Lu SPECT/CT performed on the first cycle's Day 3, up to the post-treatment quantitative 177Lu SPECT/CT performed on the last cycle's Day 3 |
From first cycle's Day 3 until the last cycle's Day 3 (each cycle is 6 weeks, up to 6 consecutive cycles)
|
|
Number of participants with any adverse events (AEs)
時間枠：From first administration to the end of treatment (each cycle is 6 weeks, up to 6 cycles)
|
All adverse events that occur from the first administration of 177Lu-PSMA-617 until 6 weeks after the last administration of 177Lu-PSMA-617 or prior to the initiation of subsequent anticancer treatment. |
From first administration to the end of treatment (each cycle is 6 weeks, up to 6 cycles)
|
|
Number of participants with laboratory adverse events (AEs)
時間枠：From date of first administration until the date of investigator-assessed progression or of the start of another anti-cancer treatment or of death, whichever came first, assessed over a minimum of 60 months
|
Adverse events seen on laboratory (hematology, biochemistry) that occur from the first administration of 177Lu-PSMA-617 until progression or until the initiation of subsequent anticancer treatment if earlier. |
From date of first administration until the date of investigator-assessed progression or of the start of another anti-cancer treatment or of death, whichever came first, assessed over a minimum of 60 months
|
|
Number of participants with delayed adverse events of special interest (AESIs)
時間枠：From date of first administration until the date of death, assessed over a minimum of 60 months
|
Delayed AESIs (renal impairment and secondary hematological malignancies) that occur from the first administration of 177Lu-PSMA-617 until death (or study termination) |
From date of first administration until the date of death, assessed over a minimum of 60 months
|
協力者と研究者
協力者
協力者
捜査官
捜査官
- 主任研究者：Jean-Mathieu Beauregard, MD、CHU de Québec-Université Laval
研究記録日
主要日程の研究
研究開始 (実際)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
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
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
その他の研究ID番号
- 2025-7829
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
There is an intent to create an imaging and data bank from this study.
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。
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