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

Not Applicable

Not yet recruiting

• Conditions: Prostate Cancer

• Registration Number: NCT06875297
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-03-04
• Study First Submitted QC: 2025-03-10
• Study First Posted: 2025-03-13
• Last Update Submitted: 2025-03-20
• Last Update Posted: 2025-03-21
• Study Start: 2025-08-05
• Primary Completion: 2027-10-08
• Study Completion: 2029-08-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 184

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Rate of patients with FPG500 mutations (ie AMP-ASCO-CAP Tier I-II) associated with biochemical relapse or PSA persistence after surgery	3 years	A raise in the PSA level is the first sign of disease progression for the whole non-metastatic PCa setting. After radical prostatectomy in high-risk patients, biochemical relapse anticipates radiographic progression and is a crucial point invoking re-staging and treatment decision making. A PSA doubling time below 8-10 months is significantly related to metastatic development and prostate cancer specific death (Smith MR, J Clin Oncol 2013;31:3800-3806).; The primary endpoint is to identify actionable mutations related to BCR (or persisting PSA) after surgery for high-risk and locally advanced PCa.
Rate of patients with FPG500 mutations (ie AMP-ASCO-CAP Tier I-II) associated with cancer progression in low-risk pts undergoing active surveillance	5 years	The primary endpoint is to identify actionable mutations related to progression of low-risk PCa. From the study from Hamdy et al, the occurrence of clinical progression requiring active treatment is as high as 25% at 15 years.; PCa cases with diagnosis of low-risk will be considered for FPG 500 genomic profiling from prostate biopsy to define mutations related to: - Upstage and/or upgrade of cancer during surveillance protocol

Secondary Outcome Measures

Name	Time	Method
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	3 years	Radiographic progression of cancers may relate with the development of symptoms and with an increased burden of cure to control clinical progression. FPG500 mutations relevant to this endpoint may suggest treatment anticipation /intensification after surgery or may be actionable of target treatment

Trial Locations

Locations (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Urologia; 🇮🇹 Roma, Italy