GU-01: Glycyrrhizin in Prostate Cancer

Официальное название

GU-01: Glycyrrhizin in Prostate Cancer: A Window-of-Opportunity Trial

Обзор

This is a pilot, randomized, window-of-opportunity treatment trial in which participants with previously untreated prostate cancer (PCa) who are candidates for surgery (radical prostatectomy)

Подробное описание

This is a pilot, randomized, window-of-opportunity treatment trial in which participants with previously untreated prostate cancer who are candidates for surgery (radical prostatectomy) will receive one cycle of therapy consisting of Glycyrrhizin (GLY) (Observation, Dose Level 1 75mg daily, or Dose Level 2, 150mg daily) for 5 weeks (+/- 2 weeks) prior to surgery.

Вмешательства

• Другое Observation
  Participants will not receive glycyrrhizin
• Препарат Glycyrrhizin - 75 mg
  Participants will either receive 75 mg orally daily
• Препарат Glycyrrhizin - 150 mg
  Participants will receive 150 mg orally daily

Первичные конечные точки

• To evaluate anti-tumor activity of GLY by assessing changes in prostate-specific antigen (PSA) after GLY treatment administration and prior to radical prostatectomy [Срок оценки: 2 months]

Вторичные конечные точки (3)

• To evaluate the tolerability of GLY treatment administered daily prior to prostatectomy. [Срок оценки: 2 months]
• To assess of clinical laboratory and pathologic correlates in patients in relation to GLY treatment administration [Срок оценки: 2 months]
• To evaluate patient perspectives on clinical trial enrollment and complementary and integrative medicine (CAM) approaches as evaluated through survey questionnaires [Срок оценки: 2 months]

Критерии участия

Критерии включения

• Age ≥ 18 years of age at time of consent
• ECOG performance status of 0, 1, or 2
• Histologic diagnosis of prostate cancer
• Patient suitable for radical prostatectomy as determined by surgical team
• Able to provide written informed consent and HIPAA authorization for release of personal health information, via an approved UIC Institutional Review Board (IRB) informed consent form and HIPAA authorization.
• Willing to use barrier contraceptive method during study intervention

Критерии исключения

• Any prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of this investigational regimen, as determined by the treating urologic oncology team.
• Previous chemotherapy, biological therapy, radiation therapy, androgens, thalidomide, immunotherapy, other anticancer agents and/or investigational agents within 30 days of starting study treatment.
• Potent or moderate inhibitors and inducers of CYP3A4 if taken within a 1 week wash-out period
• Concomitant medications known to prolong QT interval, or with factors that increase the risk of QTc prolongation, or History of Torsades de Pointes. This may include patients who have sub-optimally controlled hypertension, serum potassium levels <4.0 mEq/L, serum magnesium ≤1.8 mg/dL, prolonged gastrointestinal transit time, or decreased 11-β-hydroxysteriod dehydrogenase-2 activity.

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 · 1 центр

• University of Illinois — Chicago

Идентификаторы

NCT: NCT06378346 · 2023-077

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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