Duration of Androgen Receptor Pathway Inhibitor and ADT With Metastasis Directed Therapy in Oligometastatic Cancer of the Prostate (DIRECT)

Официальное название

Duration of Androgen Receptor Pathway Inhibitor and ADT With Metastasis Directed Therapy in Oligometastatic Cancer of the Prostate

Обзор

This is a multi-centre, investigator-initiated, three-arm, randomized trial to investigate the addition on androgen receptor pathway inhibitor and atorvastatin to standard of care radiation and hormone therapy improve quality of life. Participants will either receive standard of care radiation and hormone (ADT) therapy (Arm 1), standard of care radiation and hormone (ADT) therapy plus oral abiraterone for 8-9 months (Arm 3) or standard of care radiation and hormone (ADT) therapy plus oral abiraterone for 8-9 months plus atorvastatin for 2 years (Arm 4). Participants will be routinely follow-up in clinic or remotely for up to 5 years.

Вмешательства

• Препарат Abiraterone
  Second-generation androgen pathway inhibitor (ARAT), oral tablet
• Другое Standard of Care SBRT and ADT
  Standard of care stereotactic body radiation therapy (SBRT) and androgen deprivation therapy (ADT)
• Препарат Atorvastatin
  Lipid metabolism regulator

Первичные конечные точки

• Progression free survival [Срок оценки: 5 years]

Вторичные конечные точки (6)

• Patient-reported quality of life [Срок оценки: 5 years]
• Patient-reported quality of life [Срок оценки: 5 years]
• Physician-reported toxicity [Срок оценки: 5 years]
• Time to Testosterone Recovery [Срок оценки: 5 years]
• Improvement in Metabolic Parameters [Срок оценки: 5 years]
• Circulating Cell-Free DNA [Срок оценки: 2 years]

Критерии участия

Критерии включения

• Age > 18 years
• Able to provide informed consent
• Histologic diagnosis of prostate adenocarcinoma
• ECOG performance status 0-2
• Stage IV castrate sensitive metachronous metastatic prostate cancer. diagnosed within 6 months of study enrollment with 1-10 metastases

• Maximum one metastatic deposit on conventional imaging (CT or bone scan or MR)
• Additional metastases can be detectable by PSMA PET only
• All sites of disease are amenable to and can be safely treated with radiotherapy
• Patients decline continuous use of ADT

Exclusion Criteria (for all patients):

• Significant comorbidities rendering patient not suitable for ADT, ARPI (enzalutamide or abiraterone) and SBRT

a. Patients with significant comorbidities rendering patient not suitable for atorvastatin is not an exclusion criteria, as these patients can still enroll and be randomized between Arms 1 and 3.

• History of malignancy within the past 5 years, excluding non-melanoma skin cancer and in-situ cancer, managed non-curatively
• Prior use of salvage systemic therapy
• Evidence of spinal cord compression

Exclusion Criteria (for Arm 4 only, after randomization)

• ALT/AST > 3 x ULN
• History of myasthenia gravis or active myasthenia gravis
• History of ocular myasthenia or active ocular myasthenia

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

Канада · 2 центра

• Princess Margaret Cancer Center — Toronto
• Sunnybrook Research Institute — Toronto

Идентификаторы

NCT: NCT05404139 · 22-5274

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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