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

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Not yet enrolling

Conditions: Prostate Cancer

Treatments: Diagnostic Test: FPG500

Study type: Interventional

Funder types: Other

Identifiers

NCT06875297

IDTBD

Details and patient eligibility

About

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.

Enrollment: 184 estimated patients

Sex: Male

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

184 participants in 1 patient group

FPG500 test

Experimental group

Description:

This is a single-center prospective interventional study involving patients with histologically confirmed low-risk, high-risk and locally advanced PCa. A cancer genome profiling with FPG 500 will be performed within these cohorts. Samples will be available from surgery for high-risk and locally advanced PCa, from prostate biopsy for low risk patients.

Treatment:

Diagnostic Test: FPG500