Low-Risk Prostate CancerPSMA-ASNCT06866041
Biological Markers and Advanced Imaging for Prostate Cancer Progression in Active Surveillance
A study testing mpMRI-targeted confirmatory biopsy in people with Low-Risk Prostate Cancer, run by Università Vita-Salute San Raffaele at 1 site in Italy.
Trial summary
This study aims to identify patients with low-risk prostate cancer (ISUP Grade Group 1) eligible for active surveillance who are at higher risk of upgrading to ISUP Grade Group 2 or higher at confirmatory biopsy one year after diagnosis. Read more about this study
- Who is it for?
- Ages 45 to 80 years, men only
- Conditions the study is for
- Low-Risk Prostate Cancer
- What is being tested?
- mpMRI-targeted confirmatory biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteItaly
- Study dates
- 7 May 2025to Mar 2030
- 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 45 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven low-risk PCa (PSA ≤10 ng/ml; clinical stage ≤T2a, and biopsy ISUP GG 1)
- Non-metastatic status at study inclusion (patient enrollment).
- No prior or concomitant androgen deprivation therapy
- Ability to understand a written informed consent and willingness to sign it.
Who cannot join
- Unable to tolerate a PSMA-PET scan
- Unwillingness to be managed with AS
- Receipt of neoadjuvant or curative-intent therapies
- Pacemaker
- Inability to obtain the FFPE prostate biopsy specimens from the initial biopsy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Lucia Dambrosio contact
Italy1 site, 1 recruiting
- Recruiting
IRCCS Ospedale San Raffaele
Milan, Italy, 20132
Giorgio Gandaglia, +39 0226438068, gandaglia.giorgio@hsr.it
Lucia Dambrosio, dambrosio.lucia@hsr.it
About this study
Official title: Biological Pathways and Next-Generation Imaging Features Predicting Prostate Cancer Progression in Active Surveillance
This study aims to identify patients with low-risk prostate cancer (ISUP Grade Group 1) eligible for active surveillance who are at higher risk of upgrading to ISUP Grade Group 2 or higher at confirmatory biopsy one year after diagnosis. Patients with low-risk ISUP GG1 tumors will be selected and undergo:
- PSMA PET with calculation of SUVmax and PRIMARY-Likert score
- Whole Exome Sequencing (WES) analysis on diagnostic prostate biopsies
- Immunohistochemistry on diagnostic prostate biopsies
- Confirmatory biopsy one year after diagnosis, as recommended by international guidelines This prospective, monocentric, single-arm interventional study will assess the predictive accuracy of a multivariable model integrating next-generation imaging and molecular biomarkers to improve risk stratification in active surveillance patients.
- Conditions
- Low-Risk Prostate Cancer
- Being tested
- mpMRI-targeted confirmatory biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mpMRI-targeted confirmatory biopsyProcedure or surgery
Also called 18F-PSMA PET/MRI, WES and spatial transcriptomics on the diagnostic biopsy specimens, Multiplex immunohistochemistry on the diagnostic biopsy specimens
mpMRI-targeted confirmatory biopsy after one year from the diagnosis, according to the international guidelines
| Study group | Role | What they receive |
|---|---|---|
| single arm | Experimental | All patients with low-risk prostate cancer (ISUP Grade Group 1) eligible for active surveillance will undergo:
* PSMA-PET/MRI → Evaluation of intraprostatic PSMA expression (SUVmax, PRIMARY-likert score).
* Whole Exome Sequencing (WES) → Genomic analysis of diagnostic biopsies. Multiplex Immunohistochemistry (IHC) → Study of biomarkers on diagnostic biopsies.
Confirmation biopsy one year after diagnosis, according to international guidelines. Receives: Procedure: mpMRI-targeted confirmatory biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the Discriminative Ability of a Multivariable Model in Predicting Prostate Cancer Upgrading in Low-Risk Patients Under Active Surveillance"
To determine the discriminative ability of the multivariable model, quantified using the concordance index (c-index), to predict prostate cancer upgrading in low-risk PCa patients managed with active surveillance (AS).
Measured: Baseline diagnostic biopsy and 12 months after diagnosis (when the confirmatory biopsy will be performed)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start7 May 2025
- Primary completion7 May 2028 (estimated)
- Study completionMar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low-Risk Prostate CancerStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Università Vita-Salute San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giorgio Gandaglia, Università Vita-Salute San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06866041
- Sponsor's protocol ID
- PSMA-AS
- Acronym
- PSMA-AS
- Status last verified
- May 2025
- First submitted
- 4 Mar 2025
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological Pathways and Next-Generation Imaging Features Predicting Prostate Cancer Progression in Active Surveillance
- ClinicalTrials.gov ID
- NCT06866041
- Acronym / sponsor ID
- PSMA-AS / PSMA-AS
- Conditions
- Low-Risk Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Università Vita-Salute San RaffaeleUniversity, hospital or other
- Study start
- 7 May 2025 (actual)
- Primary completion
- 7 May 2028 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 10 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.
This study aims to identify patients with low-risk prostate cancer (ISUP Grade Group 1) eligible for active surveillance who are at higher risk of upgrading to ISUP Grade Group 2 or higher at confirmatory biopsy one year after diagnosis. Patients with low-risk ISUP GG1 tumors will be selected and undergo:
- PSMA PET with calculation of SUVmax and PRIMARY-Likert score
- Whole Exome Sequencing (WES) analysis on diagnostic prostate biopsies
- Immunohistochemistry on diagnostic prostate biopsies
- Confirmatory biopsy one year after diagnosis, as recommended by international guidelines This prospective, monocentric, single-arm interventional study will assess the predictive accuracy of a multivariable model integrating next-generation imaging and molecular biomarkers to improve risk stratification in active surveillance patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm | Experimental | Procedure: mpMRI-targeted confirmatory biopsyAll patients with low-risk prostate cancer (ISUP Grade Group 1) eligible for active surveillance will undergo: * PSMA-PET/MRI → Evaluation of intraprostatic PSMA expression (SUVmax, PRIMARY-likert score). * Whole Exome Sequencing (WES) → Genomic analysis of diagnostic biopsies. Multiplex Immunohistochemistry (IHC) → Study of biomarkers on diagnostic biopsies. Confirmation biopsy one year after diagnosis, according to international guidelines. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically proven low-risk PCa (PSA ≤10 ng/ml; clinical stage ≤T2a, and biopsy ISUP GG 1)
- Non-metastatic status at study inclusion (patient enrollment).
- No prior or concomitant androgen deprivation therapy
- Ability to understand a written informed consent and willingness to sign it.
Key exclusion criteria (5 listed)
- Unable to tolerate a PSMA-PET scan
- Unwillingness to be managed with AS
- Receipt of neoadjuvant or curative-intent therapies
- Pacemaker
- Inability to obtain the FFPE prostate biopsy specimens from the initial biopsy
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 |
|---|---|---|
| mpMRI-targeted confirmatory biopsyAlso: 18F-PSMA PET/MRI, WES and spatial transcriptomics on the diagnostic biopsy specimens, Multiplex immunohistochemistry on the diagnostic biopsy specimensmpMRI-targeted confirmatory biopsy after one year from the diagnosis, according to the international guidelines | Procedure or surgery | single arm |
Primary outcome
Assessment of the Discriminative Ability of a Multivariable Model in Predicting Prostate Cancer Upgrading in Low-Risk Patients Under Active Surveillance"
Time frame: Baseline diagnostic biopsy and 12 months after diagnosis (when the confirmatory biopsy will be performed)
To determine the discriminative ability of the multivariable model, quantified using the concordance index (c-index), to predict prostate cancer upgrading in low-risk PCa patients managed with active surveillance (AS).
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 16 May 2025.
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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.
Lucia Dambrosio contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mpMRI-targeted confirmatory biopsy in people with Low-Risk Prostate Cancer, run by Università Vita-Salute San Raffaele 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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 16 May 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 Giorgio Gandaglia (+39 0226438068, gandaglia.giorgio@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the Discriminative Ability of a Multivariable Model in Predicting Prostate Cancer Upgrading in Low-Risk Patients Under Active Surveillance" (time frame: Baseline diagnostic biopsy and 12 months after diagnosis (when the confirmatory biopsy will be performed)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 May 2025.