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Идёт набор NCT04489719

Impact of DNA Repair Pathway Alterations on Sensitivity to Radium-223 in Bone Metastatic Castration-resistant Prostate Cancer

— Наблюдательное Castration-Resistant Prostate Carcinoma Metastatic Malignant Neoplasm in the Bone Metastatic Prostate Carcinoma Stage IVB Prostate Cancer AJCC v8

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Biospecimen Collection, Questionnaire Administration, Radium Ra 223 Dichloride.
Кому может быть актуально
Состояния в реестре: Castration-Resistant Prostate Carcinoma, Metastatic Malignant Neoplasm in the Bone, Metastatic Prostate Carcinoma, Stage IVB Prostate Cancer AJCC v8. Базовые параметры: от 18 лет · Мужчины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

The Impact of DNA Repair Pathway Alterations Identified by Circulating Tumor DNA on Sensitivity to Radium-223 in Bone Metastatic Castration-Resistant Prostate Cancer

Обзор

This study investigates how well radium-223 works in treating patients with castration-resistant prostate cancer than has spread to the bones (bone metastases). Prostate cancer is the most common cancer in men and the second leading cause of cancer death. Furthermore, many men with notably advanced disease have been found to have abnormalities in DNA repair. The purpose of this research is to study the role of a DNA repair pathway in prostate cancer, specifically in response to administration of radium-223, an FDA-approved drug known to cause DNA damage to cancerous cells. Understanding how defects in the DNA repair pathway affects radium-223 treatment of prostate, may help doctors help plan effective treatment in future patients.

Подробное описание

OUTLINE:

Patients receive standard of care radium Ra 223 dichloride given by intravenous (IV) bolus every 4 weeks for up to 6 cycles. Patients undergo collection of blood every 1-3 months during radium Ra 223 dichloride treatment.

After completion of study, patients are followed up every 3 months for up to 5 years from the date of treatment completion.

Вмешательства

  • Процедура Biospecimen Collection
    Undergo collection of blood samples
  • Другое Questionnaire Administration
    Ancillary studies
  • Препарат Radium Ra 223 Dichloride
    Given IV

Первичные конечные точки

  • Response rate [Срок оценки: Up to 1 year]
Вторичные конечные точки (9)
  • Response rate [Срок оценки: Up to 1 year]
  • Response rate in those with previous PARP inhibitor therapy [Срок оценки: Up to 1 year]
  • Overall survival [Срок оценки: Up to 5 years]
  • Number of radium Ra 223 dichloride [Срок оценки: Up to 6 months]
  • Pain assessment [Срок оценки: Up to 1 year]
  • Analgesic usage [Срок оценки: Up to 1 year]
  • Quality of life (FACT-P survey) [Срок оценки: Up to 1 year]
  • Incidence of adverse events [Срок оценки: Up to 1 year]
  • Response rate [Срок оценки: Up to 1 year]

Критерии участия

Критерии включения

  • Patient must be >= 18 years of age
  • Patient must have histopathologic diagnosis of prostate cancer
  • Patient must have castration-resistant prostate cancer
  • Patient must have radiographic evidence of bone metastasis
  • Patients must be symptomatic from prostate cancer
  • Patient must have plans to undergo treatment with radium-223
  • Patient must have a PSA level >= 10 ng/mL
  • Patient must have castrate testosterone levels demonstrated within the last 3 months prior to screening
  • Patient must have anticipated survival > 3 months
  • Patient must be willing and able to authorize consent
  • Patient must be willing and able to comply with the protocol, including follow-up visits

Критерии исключения

  • Patient must not have visceral metastasis
  • Patients on regimens of radium-223 in combination with other antineoplastic agents are excluded

\* Bone-targeted only therapy (e.g. denosumab or zoledronic acid) will be allowed

  • Patients who have received prior radium-223
  • Patients who have received prior platinum containing chemotherapy
  • Absolute neutrophil count (ANC) < 1.5 x 10\^9/L
  • Hemoglobin (HB) < 9 g/dL
  • Platelets (PLT) < 100 x 10\^9/L
  • Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

США · 4 центра
  • Johns Hopkins University — Baltimore
  • Bozeman Health Deaconess Hospital — Bozeman
  • Fred Hutch/University of Washington Cancer Consortium — Seattle
  • University of Wisconsin-Madison — Madison

Идентификаторы

NCT: NCT04489719 · RG1006011 · NCI-2020-04699 · 10370

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗