Clinical trial NCT06875297: A Single-center Prospective Interventional Study on FPG500 in Non-metastatic Prostate Cancer Patients
Official title: A Comprehensive Cancer Genome Profiling to Detect Actionable Alteration Representative of Progression of Non-metastatic Prostate Cancer.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2025-03-13
Enrollment: 184
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a single-center prospective interventional study involving patients with histologically confirmed low-risk, high-risk and locally advanced PCa.

Patients' treatment will be prompted according to international Guidelines and Good Clinical Practice. A cancer genome profiling with FPG 500 will be performed within these cohorts.
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Rate of patients with FPG500 mutations (ie AMP-ASCO-CAP Tier I-II) associated with biochemical relapse or PSA persistence after surgery
timeFrame: 3 years
measure: Rate of patients with FPG500 mutations (ie AMP-ASCO-CAP Tier I-II) associated with cancer progression in low-risk pts undergoing active surveillance
timeFrame: 5 years
Secondary outcomes:
measure: 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
timeFrame: 3 years
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Urologia
Study officials:
affiliation: Fondazione
name: maria chiara
role: PRINCIPAL_INVESTIGATOR
References: