Персонализированная и фиксированная активность 177LU-PSMA-617 Радиофармацевтическая терапия (Prodigy-2) (PRODIGY-2)
Простат-специфическая мембранная дозиметрия антигена, управляемая эндорадиотерапией: рандомизированное, одно слепое, пилотное исследование персонализированного и фиксированной активности 177LU-PSMA-617 радиофармацевтическая терапия (Defigy-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.
Обзор исследования
Статус
Вмешательство/лечение
Тип исследования
Регистрация (Оцененный)
Фаза
- Фаза 1
Контакты и местонахождение
Контакты исследования
- Имя: Marie-Christine Dubé, Ph.D.
- Номер телефона: 418-525-4444
- Электронная почта: marie-christine.dube@crchudequebec.ulaval.ca
Места учебы
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Quebec
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Québec, Quebec, Канада, G1R2J6
- Рекрутинг
- CHU de Québec-Université Laval
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Контакт:
- Marie-Christine Dubé, Ph.D.
- Номер телефона: 418-525-4444
- Электронная почта: marie-christine.dube@crchudequebec.ulaval.ca
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Главный следователь:
- Jean-Mathieu Beauregard, MD
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: Персонализированная деятельность
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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 |
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Активный компаратор: Фиксированная деятельность
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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 |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Administered activity of 177Lu-PSMA-617
Временное ограничение: 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)
|
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Number of participants with subacute adverse events of special interest (AESIs)
Временное ограничение: From first administration to the end of treatment (each cycle is 6 weeks, up to 6 cycles)
|
Subacute AESIs are:
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From first administration to the end of treatment (each cycle is 6 weeks, up to 6 cycles)
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Различия оценки на анкету Euroqol-5 Dimension-5 (EQ-5D-5L) на исходном уровне
Временное ограничение: На исходном уровне, через 18 недель и в конце лечения (каждый цикл составляет 6 недель, до 6 последовательных циклов)
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На исходном уровне, через 18 недель и в конце лечения (каждый цикл составляет 6 недель, до 6 последовательных циклов)
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Изменение баллов по функциональной оценке лечения рака - анкету простаты (Fact -P) на исходном уровне
Временное ограничение: На исходном уровне, через 18 недель и в конце лечения (каждый цикл составляет 6 недель, до 6 последовательных циклов)
|
На исходном уровне, через 18 недель и в конце лечения (каждый цикл составляет 6 недель, до 6 последовательных циклов)
|
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Анкета вариации баллов по краткой боли (BPI-SF) на исходном уровне
Временное ограничение: На исходном уровне, через 18 недель и в конце лечения (каждый цикл составляет 6 недель, до 6 последовательных циклов)
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На исходном уровне, через 18 недель и в конце лечения (каждый цикл составляет 6 недель, до 6 последовательных циклов)
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Вариация оценки по вопросам междисциплинарного анкеты общества слюнных желез (MSGS) на исходном уровне
Временное ограничение: На исходном уровне, через 18 недель и в конце лечения (каждый цикл составляет 6 недель, до 6 последовательных циклов)
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На исходном уровне, через 18 недель и в конце лечения (каждый цикл составляет 6 недель, до 6 последовательных циклов)
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Best biochemical response
Временное ограничение: From first administration until 52 weeks or the start of another anti-cancer treatment or death, whichever is earliest
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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
|
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PSA progression-free survival (PSA-PFS)
Временное ограничение: 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
|
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Radiological progression-free survival (rPFS)
Временное ограничение: 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
|
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Investigator-assessed overall PFS
Временное ограничение: 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
|
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Time to first symptomatic skeletal event (SSE)
Временное ограничение: 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
|
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Overall survival (OS)
Временное ограничение: 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
|
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Metabolic response on FDG-PET/CT
Временное ограничение: 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
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Molecular response on PSMA-PET/CT
Временное ограничение: 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)
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Best molecular response on quantitative 177Lu SPECT/CT during treatment
Временное ограничение: From first cycle's Day 3 until the last cycle's Day 3 (each cycle is 6 weeks, up to 6 consecutive cycles)
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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)
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Number of participants with any adverse events (AEs)
Временное ограничение: 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)
|
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Number of participants with laboratory adverse events (AEs)
Временное ограничение: 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)
Временное ограничение: 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
|
Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Jean-Mathieu Beauregard, MD, CHU de Québec-Université Laval
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 2025-7829
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
There is an intent to create an imaging and data bank from this study.
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
продукт, произведенный в США и экспортированный из США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .