Prostate CancerNCT06875297
A Single-center Prospective Interventional Study on FPG500 in Non-metastatic Prostate Cancer Patients
A study testing FPG500 in people with Prostate Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- FPG500
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteItaly
- Study dates
- 5 Aug 2025to 7 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- previous or concomitant malignancies
- patients already undergoing androgen suppression or other medical treatments for prostate cancer
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Urologia
Roma, 00168
Maria Chiara C Sighinolfi, PhD
Maria Chiara Sighinolfi
About this study
Official title: A Comprehensive Cancer Genome Profiling to Detect Actionable Alteration Representative of Progression of Non-metastatic Prostate Cancer.
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.
Read more
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
- Prostate Cancer
- Being tested
- FPG500
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FPG500Diagnostic test
A cancer genome profiling with FPG500 will be performed on samples available from surgery or biopsy. Specimen are reviewed to assess tumor cell fraction. All H\&E slides are digitized before nucleic acid extraction. Semi-automated process is used for DNA/RNA extraction, DNA fragmentation, quantification, library preparation, and sequencing. Profiling is done with the TruSight Oncology 500 assay, analyzing 523 genes for single nucleotide variants, insertions/deletions, copy number variations, and fusions/splicing variants in 55 genes. It also evaluates genomic signatures like microsatellite instability and tumor mutational burden. Sequencing data are processed using Illumina software and a custom pipeline. Post-sequencing quality control is performed. Variants are classified according to the Human Genome Variation Society and clinical actionability guidelines. Genomic report is reviewed by an institutional Molecular Tumor Board.
| Study group | Role | What they receive |
|---|---|---|
| FPG500 test | Experimental | 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. Receives: Diagnostic Test: FPG500 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients with FPG500 mutations (ie AMP-ASCO-CAP Tier I-II) associated with biochemical relapse or PSA persistence after surgery
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.
Measured: 3 years
Rate of patients with FPG500 mutations (ie AMP-ASCO-CAP Tier I-II) associated with cancer progression in low-risk pts undergoing active surveillance
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
Measured: 5 years
Secondary outcomes (1)
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
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
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start5 Aug 2025 (estimated)
- Primary completion8 Oct 2027 (estimated)
- Study completion7 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- maria chiara, Principal investigator, Fondazione
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06875297
- Sponsor's protocol ID
- IDTBD
- Status last verified
- Feb 2025
- First submitted
- 4 Mar 2025
- Last updated
- 21 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sighinolfi 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.
PubMed 41070807
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comprehensive Cancer Genome Profiling to Detect Actionable Alteration Representative of Progression of Non-metastatic Prostate Cancer.
- ClinicalTrials.gov ID
- NCT06875297
- Acronym / sponsor ID
- IDTBD
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 5 Aug 2025 (estimated)
- Primary completion
- 8 Oct 2027 (estimated)
- Study completion
- 7 Aug 2029 (estimated)
- First posted
- 13 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| FPG500 test | Experimental | Diagnostic Test: FPG500This 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- previous or concomitant malignancies
- patients already undergoing androgen suppression or other medical treatments for prostate cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FPG500A cancer genome profiling with FPG500 will be performed on samples available from surgery or biopsy. Specimen are reviewed to assess tumor cell fraction. All H\&E slides are digitized before nucleic acid extraction. Semi-automated process is used for DNA/RNA extraction, DNA fragmentation, quantification, library preparation, and sequencing. Profiling is done with the TruSight Oncology 500 assay, analyzing 523 genes for single nucleotide variants, insertions/deletions, copy number variations, and fusions/splicing variants in 55 genes. It also evaluates genomic signatures like microsatellite instability and tumor mutational burden. Sequencing data are processed using Illumina software and a custom pipeline. Post-sequencing quality control is performed. Variants are classified according to the Human Genome Variation Society and clinical actionability guidelines. Genomic report is reviewed by an institutional Molecular Tumor Board. | Diagnostic test | FPG500 test |
Primary outcome
Rate of patients with FPG500 mutations (ie AMP-ASCO-CAP Tier I-II) associated with biochemical relapse or PSA persistence after surgery
Time frame: 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
Time frame: 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
1 secondary outcome
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
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Derived from this study: PubMed 41070807Sighinolfi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
maria chiara principal investigator
Fondazione
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FPG500 in people with Prostate Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria Chiara Sighinolfi (0039 3921329216, mariachiara.sighinolfi@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients with FPG500 mutations (ie AMP-ASCO-CAP Tier I-II) associated with biochemical relapse or PSA persistence after surgery (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06875297, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025; AzTrials last refreshed its copy on 2 Nov 2026.