Genetic testing to find changes linked to prostate cancer progression
Tests a genetic profiling program in adults with non-metastatic prostate cancer.
Key facts
- Who runs it
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Where
- Roma, ItalySee the site
- Trial code
- Registry title
- A Single-center Prospective Interventional Study on FPG500 in Non-metastatic Prostate Cancer Patients
- Status
- Not yet recruiting
- People taking part
- 184 people, planned
- Started
- 5 Aug 2025
- Expected to end
- 7 Aug 2029
- Type of study
- Interventional
- Treatments tested
- FPG500
- Record updated
- 21 March 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for men aged 18 to 75 with proven non-metastatic prostate cancer: low-risk, high-risk or locally advanced. Their tumour will get a genetic test of over 500 genes.
- Age
- 18 Years to 75 Years
- Sex
- Men only
- Disease stage
- Low-risk, high-risk or locally advanced prostate cancer, confirmed by tissue examination. High-risk and locally advanced cases must be having surgery. Low-risk cases must be on active surveillance or having surgery.
- Earlier treatment
- People already on androgen suppression or other medical treatment for prostate cancer cannot join.
Main reasons for not taking part
- Previous or concomitant malignancies
- Already on androgen suppression for prostate cancer
- Already on other medical treatments for prostate cancer
The registry criteria, word for word
Show all 5 criteriaShow less
Who can take part
- 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
Who cannot take part
- previous or concomitant malignancies
- patients already undergoing androgen suppression or other medical treatments for prostate cancer
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Where in Italy
- Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC UrologiaRoma, ItalyContact: Maria Chiara C Sighinolfi, PhDNo longer taking part
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The group in the trial
- FPG500 testTreatment being tested
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: FPG500
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Comprehensive Cancer Genome Profiling to Detect Actionable Alteration Representative of Progression of Non-metastatic Prostate Cancer.
- Plain-language title
- Genetic testing to find changes linked to prostate cancer progressionGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06875297, who can take part
- Record updated
- 21 March 2025