ExosomeDx in MRI-negative Men With High PSA

Официальное название

Evaluation of Urinary Exosomes as a Risk Stratification Tool Among Men With Elevated PSAs and Negative Prostate MRIs

Обзор

Magnetic resonance imaging (MRI) has become the current standard of care in risk stratifying men with an elevated Prostate-specific antigen (PSA) to determine who needs to undergo prostate biopsy, which is invasive and carries a 3-5% risk of serious infection. Recent data shows the negative predictive value of MRI to be only 77%, indicating that some men may inappropriately forego biopsy based on a negative MRI. Urinary exosomes can be captured and analyzed by the ExosomeDx (ExoDx) Prostate test, a urine based, gene signature derived from PCA3 (prostate cancer antigen 3) and ERG (erythroblast transformation-specific related gene), and SPDEF (SAM pointed domain-containing ETS transcription factor); ExoDx carries a 90% negative predictive value. The use of ExoDx test among patients with negative MRIs has the potential to improve the risk stratification of patients with an elevated PSA in a way that the Urologist can more accurately determine which patients need to undergo prostate biopsy. In doing so, the Urologist can better risk-stratify which patients should undergo prostate biopsy and be exposed to the associated potential risks, and also be more confident about the safety of foregoing biopsy in those patients with negative MRI and negative ExoDx test.

Вмешательства

• Устройство Urinary ExoDx test
  A urine sample for ExoDx Study Kit will be collected onsite and shipped to Exosome Diagnostic's laboratory.
• Диагностический тест Transrectal ultrasound-guided prostate biopsy
  Participants will be scheduled for transrectal ultrasound-guided prostate biopsy as per the standard diagnostic practice after urinary test.
• Диагностический тест Transperineal 12-core prostate biopsy
  Participants will be scheduled for transperineal 12-core prostate biopsy as per the standard diagnostic practice after urinary test.

Первичные конечные точки

• Sensitivity [Срок оценки: duration of study, average 3 months]
• Specificity [Срок оценки: duration of study, average 3 months]

Вторичные конечные точки (7)

• Cancer Detection Rate [Срок оценки: duration of study, average 3 months]
• csPCa Detection Rate [Срок оценки: duration of study, average 3 months]
• Biopsy aversion rate [Срок оценки: duration of study, average 3 months]
• Net Benefit [Срок оценки: duration of study, average 3 months]
• Diagnostic Accuracy [Срок оценки: duration of study, average 3 months]
• Positive Predictive Value (PPV) [Срок оценки: duration of study, average 3 months]
• Negative Predictive Value (NPV) [Срок оценки: duration of study, average 3 months]

Критерии участия

Критерии включения

To be eligible to participate in this study, an individual must meet all the following criteria;

• Willingness to participate and provide signed and dated informed consent form
• Male (sex)
• Age ≥ 18 years
• PSA screen-eligible, per investigator discretion

• 45-75 years of age for average risk
• 40-75 years of age for high risk
• PSA ≥ 2.0 ng/mL and ≤ 10.0 ng/mL
• MRI PIRADS score of 1 or 2
• ECOG 0-1
• Must have a negative urine culture prior to biopsy
• No prior prostate biopsies within the last 5 years (biopsy-naïve)
• Willingness to undergo a prostate biopsy as part of the diagnostic work-up
• Digital rectal exam with no palpable nodules

Критерии исключения

An individual who meets any of the following criteria will be excluded from participation in this study;

• Prior or current histologic or pathologic confirmed diagnosis of prostate cancer
• Prior transrectal ultrasound within the last 5 years
• Any prior cancer diagnosis within the last 5 years
• On immunosuppression or predefined immunosuppressed state
• A known coagulopathy predisposition to bleeding
• Diagnoses of any uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements
• Cognitive inability or psychiatric conditions that preclude informed decision making or compliance with study requirements (per investigator discretion)

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

Диагностика

Центры проведения

США · 6 центров

• Mount Sinai Beth Israel / Union Square — New York
• Mount Sinai West — New York
• Mount Sinai Morningside — New York
• Mount Sinai Hospital — New York
• Mount Sinai Queens — New York
• Mount Sinai Brooklyn — New York

Идентификаторы

NCT: NCT06966089 · STUDY-24-00010

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗