Utility of Biparametric MRI (Magnetic Resonance Imaging) as a Screening Tool for Prostate Cancer in a High-Risk Cohort

Обзор

To determine whether using bpMRI in subjects who are at high risk of developing prostate cancer in conjunction with PSA will improve prostate cancer screening protocols.

Подробное описание

The Investigators propose a pilot study which utilizes bpMRI in conjunction with PSA in the early detection of clinically significant prostate cancer in a high-risk group. Our study would focus on these high-risk subjects between the ages of 40-55 with a normal PSA ranging from ≥1.0 to \<2.5 ng/mL. bpMRI would be obtained in this group of subjects. If any suspicious lesions are found, the recommendation is to undergo MRI/US fusion biopsy. Subjects with negative bpMRI will be followed every year with serum PSA. Subjects with a positive bpMRI will have a prostate fusion and systematic biopsy performed. Those with a benign biopsy will be followed every year with serum PSA. Those who have a biopsy positive for cancer will be managed and followed according to the standard of care. All subjects will be followed for 5 years. Our hypothesis is that bpMRI in conjunction with above average PSA in a high-risk group will increase detection of clinically relevant prostate cancer and provide a useful addition to PSA screening.

Вмешательства

• Диагностический тест Bi-parametric MRI
  When used for the evaluation of prostate cancer, MRI typically involves multiple sequences and typically includes typical T1 and T2 phases with the addition of diffusion weighted imaging and dynamic contrast enhanced imaging. In this study, we have decided to omit dynamic contrast enhanced imaging due to its decreased diagnostic yield relative to T2 and DWI and associated increased risk of contrast agents, this is a common approach for prostate cancer screening and is referred to as a bi-paramet

Первичные конечные точки

• Proportion of suspicious lesions on MRI in men with PSA less than 2.5 ng/ml [Срок оценки: 3 months]

Вторичные конечные точки (3)

• Prostate cancer detection rate using 3T bpMRI in patients with high risk and suspicious lesions on bpMRI [Срок оценки: 3 months]
• Association of whether findings on bpMRI and serum PSA (i.e. PSA density) are associated with future diagnosis of prostate cancer. [Срок оценки: 5 years]
• To correlate bpMRI findings with future changes in PSA [Срок оценки: 5 years]

Критерии участия

Критерии включения

• PSA between 1.0 and 2.5 ng/dL
• High risk for prostate cancer, i.e. Black or they have a first degree relative with history of prostate cancer (father, brother) or specific genetic syndromes i.e. BRCA 1/2, HOX B13, Lynch syndrome, ATM, CHEK2
• Patient is willing to participated in prostate cancer screening
• Patient is capable of giving informed consent

Критерии исключения

• Nodularity or firmness of prostate on exam
• Patient has undergone a prior biopsy or prostate surgery
• Patient is taking 5-alpha reductase inhibitors to manage benign prostatic hyperplasia, as this can significantly alter PSA levels.
• Patient has a history of UTI or prostatitis in the preceding 6 months, as this can significantly alter PSA levels.
• Patient has a contraindication to MRI, these include but are not limited to pacemakers, neurostimulator devices, metal cardiac valves, certain tattoos, or foreign bodies
• Participants that experience claustrophobia, anxiety and/or vertigo when moved inside the scanner
• The participant cannot tolerate lying flat for the study duration

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Скрининг

Центры проведения

США · 1 центр

• Cynthia Knauer — Lake Success

Публикации

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Идентификаторы

NCT: NCT05384535 · 21-1380

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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