Clinical trial · Interventional
A Single-center Prospective Interventional Study on FPG500 in Non-metastatic Prostate Cancer Patients
A Comprehensive Cancer Genome Profiling to Detect Actionable Alteration Representative of Progression of Non-metastatic Prostate Cancer.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FPG500 | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- FPG500 test
- 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.
- interventionNames
- Diagnostic Test: FPG500
Primary outcomes (2)
- 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
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDSighinolfi 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. 2025 Dec;136(6):1022-1027. doi: 10.1111/bju.70019. Epub 2025 Oct 10. PMID 41070807