Prostate Cancer Early Detection Using Serial MRI Examinations

Обзор

The rationale of the PROCEDE trial is to explore a novel early detection strategy in which biopsy decision does not rely on one single MRI examination, but on the progression of the MRI lesion between 2 consecutive exams, with the objective of reducing the number of unnecessary biopsies, detection of non-clinically prostate cancer and, ultimately, overtreatment.

Вмешательства

• Процедура MRI Examination
  Patients randomized to the experimental arm will proceed with MRI surveillance. A follow-up visit is planned at 6 months with the result of a PSA test, and it is possible at each investigator's discretion, to prescribe the follow-up MRI at 6 months in case of rising PSA. Otherwise, the repeat MRI will be scheduled one year after the initial MRI. Images will also be sent to the coordinating center for central reviewing of the new MRI exam and assessment of progression.

Первичные конечные точки

• To evaluate the impact of a novel early detection strategy based on serial MRI [Срок оценки: at 2 years]

Вторичные конечные точки (8)

• To assess the impact of a new early-detection strategy based on repeated MRI [Срок оценки: at 5 years.]
• To assess the impact of the new strategy on the number of prostate biopsies performed [Срок оценки: at 2 years and 5 years.]
• To assess changes in therapeutic options with the new strategy [Срок оценки: at 2 years and 5 years.]
• To assess the oncologic safety with Adverse pathological criteria (pT3, pN1, detectable PSA)of the new strategy compared with the usual strategy [Срок оценки: at 2 years and 5 years.]
• To assess the oncologic outcomes (Biochemical recurrence-free survival, disease-specific survival and overall survival.of the new strategy compared with the usual strategy [Срок оценки: at 2 years and 5 years.]
• To assess the impact of the new strategy on patients' anxiety levels and quality of life, evaluated at Day 0 and then annually for 5 years. [Срок оценки: at 5 years]
• To evaluate the cost-effectiveness of the new early-detection strategy compared with the standard of care from a societal perspective [Срок оценки: at 5 years.]
• To establish an MRI database enabling comparison of radiomic characteristics between patients who have progressed and those who have not, in order to identify new imaging features associated with disease progression. [Срок оценки: at 5 years]

Критерии участия

Критерии включения

• Men aged over 18 years
• Men with an estimated life expectancy of more than 10 years
• Biopsy-naïve men
• PSA level ≤ 20 ng/ml
• Presence, on the first multiparametric prostate MRI, of a PIRADS 3-5 lesion confirmed by local rereading if the MRI was performed outside the center
• MRI of sufficient quality (PI-QUAL score 2-3)
• PIRADS 3 lesion with a PSA density <0.15 ng/ml/ml
• No signs of extracapsular extension or seminal vesicle invasion (MRI stage T2 confirmed by local rereading if MRI performed outside the center)
• No suspicious lymph node (confirmed by local rereading if MRI performed outside the center)
• Patient is insured (affiliated with the national health insurance system or benefiting from such coverage)
• Signed informed consent form

Критерии исключения

• Men already under surveillance for a known MRI lesion (except if the previous MRI was performed less than 6 months ago)
• Known mutation in DNA repair genes or suggestive family history
• PIRADS 3 lesion with PSA density < 0.15 ng/ml/ml
• PIRADS 5 lesion with suspected extracapsular extension or seminal vesicle invasion
• Suspicion of lymph node involvement
• Multiparametric prostate MRI showing a PIRADS 1-2 lesion
• Use of treatments that may modify the appearance of MRI lesions: 5-alpha reductase inhibitors, hormone therapy
• Patient with severe renal insufficiency (GFR < 30 ml/min/1.73 m²)
• Contraindication to gadolinium injection
• Contraindication to prostate biopsy
• Vulnerable persons (covered by Articles L1111-6 to L1111-8 of the French Public Health Code)

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

Франция · 1 центр

• university Hospital Grenoble — Grenoble

Идентификаторы

NCT: NCT07355504 · 38RC24.0296

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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