177Lu-PSMA as a Systemic Adjuvant Treatment in Patients With High and Very High Risk Prostate Cancer

Официальное название

177Lu-PSMA as a Systemic Adjuvant Treatment in Patients With High- and Very High-risk Prostate Cancer After Radical Treatment Using Locoregional Teleradiotherapy and Hormone Therapy

Обзор

Single-center, non-commercial phase 2 clinical trial to evaluate 177Lu-PSMA as a systemic adjuvant treatment in patients with high and very high risk prostate cancer after radical treatment using locoregional teleradiotherapy and hormone therapy

Подробное описание

The intervention will consist of a single administration of 177Lu-PSMA in the research arm. Both the study and control groups will receive standard hormone therapy.

The study population includes 200 adult men with high-risk or very high-risk prostate cancer, with no signs of cancer dissemination in radiological examinations after completion of radiotherapy and continued hormone therapy

Participation time in the Study:

intervention phase - 1 day; observation phase - 5 years

Вмешательства

• Препарат Lutetium (177Lu) vipivotide tetraxetan
  The intervention will consist of a single administration of 7,4 GBq of lutetium (177Lu) vipivotide tetraxetan

Первичные конечные точки

• Treatment effectiveness [Срок оценки: 2 and 5 years after end of treatment]

Вторичные конечные точки (5)

• Biochemical progression-free survival [Срок оценки: During the intervention and follow up period (assessed up to 5 years)]
• Radiological progression-free survival [Срок оценки: During the intervention and follow up period (assessed up to 5 years)]
• Time until the next therapeutic intervention [Срок оценки: During the intervention and follow up period (assessed up to 5 years)]
• Incidence of Treatment-Emergent Adverse Events according to CTCAE v 5.0 [Срок оценки: During the intervention and follow up period (assessed up to 5 years)]
• Quliaty of life [Срок оценки: During the intervention and follow up period (assessed up to 5 years)]

Критерии участия

Критерии включения

• Giving a written informed consent
• Histopathologically confirmed high or very high risk prostate cancer
• Completion of radical locoregional treatment
• Completion of locoregional treatment within 3 months before inclusion to the study
• ECOG performance status 0 to 2
• Age over 18 years
• Within 28 days before entering the study, there were no signs of cancer dissemination documented in radiological tests
• Castrate testosterone level (testosteron < 50 ng/dL lub 1,7 nmol/L)
• Patients with adequate function of main organs:

• bone marrow:

• neutrophils > 1500x10\^9/L;
• thrombocytes > 100,000x10\^9/L;
• hemoglobin > 9 g/dL
• liver:

• bilirubin < 2xULN (upper limit of normal) in patients with Gilbert's syndrome < 5xULN;
• aminotransferase < 3xULN
• kidneys:

• eGFR > 50 ml/min
• albumin >2.5 mg/ml
• For men of reproductive age: the need to use double barrier contraception

Критерии исключения

• The presence of distant metastases confirmed by radiological examination
• Absence of approval to use effective contraception method
• Absence of Patient's consent to participate in the Study
• Urinary tract obstruction or/and hydronephrosis.
• Concurrent anticancer treatment.

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

Польша · 1 центр

• Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch — Gliwice

Идентификаторы

NCT: NCT06449781 · PSMA-ADJUVO · Nr EU CT: 2023-504912-13-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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