A Single-center Prospective Interventional Study on FPG500 in Non-metastatic Prostate Cancer Patients

Официальное название

A Comprehensive Cancer Genome Profiling to Detect Actionable Alteration Representative of Progression of Non-metastatic Prostate Cancer.

Обзор

The search for clinically actionable alterations within the non-metastatic prostate cancer setting has been an overlooked issue so far. Genomic alterations predicting tumor progression or representative of micrometastatic spread could be crucial to prompt the correct treatment strategy, sequencing and possible intensification in the high-risk and locally advanced settings. Similarly, the definition of the genomic landscape in low-risk patients progressing to more aggressive disease could be of importance to prompt an immediate active treatment to those patients otherwise eligible to active surveillance. A CGP program has been launched by the Fondazione Policlinico Universitario Agostino Gemelli IRCCS (FPG), a leading Italian research hospital (ID: FPG500, ethical approval number 3837) and it convers 10 cancer types. This program offers genomic testing of over 500 genes through an efficient in-house process. To now, a CGP from FPG 500 has been applied to cholangiocarcinoma, endometrial cancer, non-small cell lung cancer. Investigators propose a prospective interventional single center study whose aim is to implement a comprehensive genome profiling (CGP) through this next generation sequencing (NGS) program for non-metastatic PCa and to define actionable mutations that correlate with tumor progression. The actionability relies on the opportunity to intensify treatment in non metastatic cases at risk of progression or to identify distant spread before it becomes biochemically and/or radiographically evident for high risk non metastatic cancers. From previous research, a genomic profiling may reveal distinct mutations or gene expression patterns linked to metastasis, biochemical recurrence, and PSA persistence. Some of these genomics alterations may be associated with poorer outcomes in high-risk and locally advanced patients. Conversely, patients under active surveillance might exhibit a more stable genomic profile, with fewer mutations representative of aggressive disease. Expected outcomes will include the development of accurate prognostic tools, allowing for better-tailored treatment plans and early intervention strategies to manage disease progression.

Вмешательства

• Диагностический тест FPG500
  A cancer genome profiling with FPG500 will be performed on samples available from surgery or biopsy. Specimen are reviewed to assess tumor cell fraction. All H\&E slides are digitized before nucleic acid extraction. Semi-automated process is used for DNA/RNA extraction, DNA fragmentation, quantification, library preparation, and sequencing. Profiling is done with the TruSight Oncology 500 assay, analyzing 523 genes for single nucleotide variants, insertions/deletions, copy number variations, and

Первичные конечные точки

• Rate of patients with FPG500 mutations (ie AMP-ASCO-CAP Tier I-II) associated with biochemical relapse or PSA persistence after surgery [Срок оценки: 3 years]
• Rate of patients with FPG500 mutations (ie AMP-ASCO-CAP Tier I-II) associated with cancer progression in low-risk pts undergoing active surveillance [Срок оценки: 5 years]

Вторичные конечные точки (1)

• Rate of patients with FPG500 mutations in high risk non-met pts - non-met definition based on conventional and/or PSMA/PET imaging - with fast radiographic progression after surgery, suggesting a micrometastatic status at diagnosis [Срок оценки: 3 years]

Критерии участия

Критерии включения

• histologically proven diagnosis of low-risk, or high-risk or locally advanced prostate cancer
• high-risk and locally advanced prostate cancer undergoing surgery
• low-risk prostate cancer undergoing active surveillance or surgery

Критерии исключения

• previous or concomitant malignancies
• patients already undergoing androgen suppression or other medical treatments for prostate cancer

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

Италия · 1 центр

• Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Urologia — Roma

Публикации

• Sighinolfi MC, Pallotta G, Assumma S, Panio E, Pinto F, Gavi F, Totaro A, Presutti S, Pasciuto T, Nero C, Del Re M, Tagliaferri L, Ciccarese C, Iacovelli R, Gabarrini A, Patel E, Moschovas MC, Patel V, Rocco B. A novel comprehensive cancer genome profiling for non-metastatic prostate cancer: study protocol with FPG500 to detect actionable alterations representative of progressive disease. BJU Int. PMID 41070807

Идентификаторы

NCT: NCT06875297 · IDTBD

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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