Multicenter Assessment of Clinical Utility PET / MR With the Use of the Radiotracer 68Ga-PSMA-11 in Therapy Planning Personalized in Patients With Prostate Cancer

Обзор

The aim of multicentre phase 3 trial is evidence diagnostic value of 68Ga-PSMA-11 (in PET / CT and PET / MR techniques) in patients with high-risk and intermediate prostate cancer before radical treatment and in diagnosed patients biochemical recurrence after radical treatment

Вмешательства

• Лучевая терапия Radiopharmaceutical 68Ga-PSMA-11 PET/CT
  The radiopharmaceutical will be administered intravenously in doses with an activity of 1.8-2.2 MBq / kg b.w.

Первичные конечные точки

• Sensivity of the radiopharmaceutical 68Ga-PSMA-11 compared to PET/MR and PET/CT [Срок оценки: 24 months]

Вторичные конечные точки (6)

• Establishing a therapeutic path depending on the PET/MR and PET/CT [Срок оценки: 24 months]
• Detection of the site of recurrence [Срок оценки: 24 months]
• Determination of PSA concentration [Срок оценки: 24 months]
• Number of participants with adverse events related to 68Ga-PSMA-11 [Срок оценки: 24 months]
• Absorbed radiation dose [Срок оценки: 24 months]
• Evaluation of pharmacoeconomic data [Срок оценки: 24 months]

Критерии участия

Критерии включения

Group 1. Patients with diagnosis or high probability of medium and high prostate cancer according International Society of Urological Pathology (ISUP) risk for whom radical treatment is planned

• Prostate adenocarcinoma confirmed by biopsy and histopathological examination
• Results indicating a moderate RGK (Gleason score 7 or cT2b or PSA 10-20 ng / ml) or high (Gleason score> 7 or cT2c or PSA> 20 ng / ml) risk according to ISUP
• Creatinine value allowing for safe PET / MR examination with a contrast agent: creatinine less than or equal to 1.5 times the upper limit of normal, creatinine clearance> 60 mL / min
• Age ≥18 years
• Signing informed consent to participate in the study
• Pelvic / prostate mpMR examination performed, not earlier than 30 days before inclusion in the study

Group 2. Patients with RGK after radical treatment, with biochemical recurrence according to EAU criteria, who are scheduled for further treatment and the result of the imaging / molecular examination may affect change of therapeutic decision:

• Prostate adenocarcinoma confirmed by biopsy and histopathological examination
• After radical treatment
• In patients after radical prostatectomy: with at least two PSA measurements ≥0.2 ng / ml not earlier than after 6-13 weeks after radical prostatectomy or PSA≥0.1 with PSAdt (PSA doubling time) <3 months PSA on at least two consecutive studies in consecutive last 6 months before qualification (last determination within 6 weeks before qualification) Or
• In patients after radical radiotherapy: biochemical recurrence defined as nadir PSA + 2 ng / ml
• Age ≥18 years
• Signing informed consent

Критерии исключения

• Presence of metallic foreign bodies / implants / prostheses / stimulators etc. inside the body, the possession of which is a contraindication to the MR 3T examination
• Claustrophobia
• Patient size precluding PET / MR examination due to diameter gantry
• Known contraindications for the use of radiopharmaceuticals or substances auxiliary (e.g. renal failure and allergy to ingredients in the preparation)
• Treatment for malignant neoplasm not associated with the prostate gland
• Participating in another clinical trial
• Lack of informed consent to participate in the study
• Age <18 years

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 · 7 центров

• Białystok Oncology Center Maria Skłodowska-Curie — Bialystok
• University Clinical Hospital in Białystok — Bialystok
• Independent Public Health Care Center of the Ministry of Internal Affairs and Administrati — Bialystok
• Laboratory of Molecular Imaging and Technology Development — Bialystok
• Oncology Center named after prof. F. Łukaszczyk in Bydgoszcz — Bydgoszcz
• Provincial Multidisciplinary Center of Oncology and Traumatology named after M. Copernicus — Lodz
• Center of Oncology of the Lublin Region St. Jana z Dukli — Lublin

Идентификаторы

NCT: NCT05582876 · 2020/ABM/01/00074

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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