PSMA-PET Imaging for Detecting Early Metastatic Prostate Cancer in Men w/ High Decipher Test Scores

Официальное название

The Utility of PSMA-PET Imaging for Detecting Early Metastatic Prostate Cancer in Men With High GC Decipher® Test Scores: A Sub-aim of the VANDAAM Study (MCC #18523)

Обзор

This study will enroll 60 patients previously enrolled to MCC#18523, "A Validation Study on the Impact of Decipher® Testing on Treatment Recommendations in African-American and Non-African American Men with Prostate Cancer: (VANDAAM)" that had high risk Decipher test results (Decipher score \>0.45). Patients with a high genomic classifier (GC) score at diagnosis will be approached for formal consenting for PSMA-PET imaging at 2 years post treatment.

Подробное описание

Normally, some patients with prostate cancer undergo imaging tests to determine the extent (spread) of their disease. These imaging tests often give good information, but not in all patients and not every time. This study deals with a new imaging test known as F-DCFPyL-Prostate-specific Membrane Antigen (PSMA) Positron Emission Tomography (PET), or F-DCFPyL-PSMA PET. The objective of this study is to evaluate safety and usefulness of using F-DCFPyL in detecting recurrent/metastatic prostate cancer. The F-DCFPyL PET imaging technique is used in some parts of the world but is not currently standard imaging care. Better understanding how this new imaging test performs in identifying recurrent/metastatic prostate cancer may lead to better management of prostate cancer patients in the future.

Вмешательства

• Препарат F-DCFPyL Injection
  F-DCFPyL Injection is a radioactive diagnostic imaging agent indicated for imaging of patients with recurrent prostate cancer.
• Диагностический тест PSMA PET
  PSMA PET imaging (for men with high GC \>0.45) will be done after 2 years post-treatment, then yearly up to 5 years.

Первичные конечные точки

• Concordance (AUC) Between High Tumor GC Risk Score and Positive PSMA-PET Imaging Findings [Срок оценки: Up to 5 years]

Вторичные конечные точки (1)

• Rate of Positive PSMA-PET Findings [Срок оценки: Up to 5 years]

Критерии участия

Критерии включения

• This study will enroll 60 patients previously enrolled to MCC#18523, "A Validation Study on the Impact of Decipher® Testing on Treatment Recommendations in African-American and Non-African American Men with Prostate Cancer: (VANDAAM)" that had high risk Decipher test results (Decipher score >0.45).
• Eastern Cooperative Oncology Group (ECOG) Performance Status: 0-1
• Previously enrolled to MCC#18523
• Genomic Classifier (GC) testing successfully completed on biopsy and/or surgical specimen
• Decipher score from participation on the MCC#18523 study meets the criteria for high-risk (>0.45)
• Treated with radical prostatectomy (RP) or radiation therapy (RT) (+/- short-term androgen deprivation therapy (ADT)) with ≥2 years follow up
• Age > 18

Критерии исключения

• No follow up information available post treatment
• Unable to undergo PET imaging due to pre-existing comorbidities and/or claustrophobia
• Administration of any radioisotope within 5 physical half-lives OR any IV X-ray contrast medium within 24 hours OR any high-density oral contrast medium (oral water contrast acceptable) within 5 days prior to study drug injection

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 · 1 центр

• H. Lee Moffitt Cancer Center and Research Institute — Tampa

Идентификаторы

NCT: NCT03495427 · MCC-19291

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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