Metastatic Castrate-Resistant Prostate Cancer Subjects Treated With PROVENGE® + One Infusion of Sipuleucel-T

Официальное название

An Open -Label, Multicenter Study of Subjects With Metastatic Castrate-Resistant Prostate Cancer Treated With PROVENGE ® and Boosted With A Single Infusion of Sipuleucel-T to Measure Immune Response

Обзор

A multicenter, open-label, prospective study to investigate immune boost response changes in patients with metastatic castrate-resistant prostate cancer (mCRPC).

Подробное описание

Those enrolled in the Booster Study will have had their course of treatment with PROVENGE® immunotherapy and then randomized to the Booster Study to be treated with a single booster dose of sipuleucel-T.

Вмешательства

• Препарат Sipuleucel-T Injection
  Single Infusion

Первичные конечные точки

• Assess humoral immune response to PAP and PA2024 after booster infusion [Срок оценки: Once all subjects have completed the study through the 5 year Overall Survival Period]

Вторичные конечные точки (2)

• Evaluate the incidence of adverse events including laboratory abnormalities after a single booster does of sipuleucel-T [Срок оценки: Once all subjects have completed the study through the 5 year Overall Survival Period]
• Evaluate Overall Survival [Срок оценки: Once all subjects have completed the study through the 5 year Overall Survival Period. To evaluate safety by determining the incidence of adverse events (AEs), assessing laboratory data for clinically significant laboratory abnormalities, and evaluating]

Критерии участия

Критерии включения

For a subject to be eligible for participation in this study, all of the following criteria must be satisfied:

• Potential subjects are men aged ≥18 years who are clinically indicated for treatment with PROVENGE® (asymptomatic or minimally symptomatic metastatic castrate-resistant \[hormone refractory\] prostate cancer).
• Have qualified for on-label PROVENGE® infusion
• Have received all 3 infusions of PROVENGE® prior to randomization
• Written informed consent provided prior to the initiation of study procedures
• Estimated life expectancy ≥12 months

Критерии исключения

A subject will not be eligible for participation in this study if any of the following criteria apply.

• Men who are not clinically indicated for treatment with PROVENGE® (asymptomatic or minimally symptomatic metastatic castrate-resistant \[hormone refractory\] prostate cancer).
• Need for systemic chronic immunosuppressive therapy, including antitumor necrosis factor alpha monoclonal antibodies, glucocorticoids, systemic steroids, blood products, GM-CSF or granulocyte colony-stimulating factor (G-CSF), any vaccinations, or experimental and investigational therapies (see Section 6.3.1)
• Uncontrolled, concurrent illness, including, but not limited to the following: ongoing or active infection (bacterial, viral, or fungal), or psychiatric illness that would limit compliance with study requirements, as well as any condition that would preclude a subject from completing PROVENGE® or sipuleucel-T treatment.
• On experimental or investigational therapy.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 31 центр

• Arizona Urology Specialists — Tuscon
• City of Hope - National Medical Center — Duarte
• Urology Associates of Central California Medical Group — Fresno
• Unio Health Partners - Genesis Research, LLC — San Diego
• Colorado Urology — Lakewood
• Advanced Urology Institute — Daytona Beach
• Advanced Urology Institute — Largo
• Advanced Urology Institute — Ocala
• … и ещё 23 центра

Идентификаторы

NCT: NCT06134232 · P23-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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