Prostate CancerPhase 2NCT05815316
18F-PSMA PET/MRI for the Diagnosis of Clinically Significant Prostate Cancer
A Phase 2 study testing 18F-PSMA-1007 in people with Prostate Cancer, run by IRCCS San Raffaele.
Trial summary
This project aims to evaluate the role of fully hybrid PET/MRI with 18F-PSMA and multiparametric MR imaging (mpMRI) as one-stop approach for the diagnosis of clinically significant prostate cancer (csPCa). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- 18F-PSMA-1007
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 30 Apr 2023to 29 Apr 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men at least 18 years of age referred with clinical suspicion of prostate cancer candidate for prostate biopsy
- Feasibility to undergo all procedures listed in protocol
- Ability to provide written informed consent
Who cannot join
- Prior diagnosis of prostate cancer
- Contraindication to MRI (e.g. claustrophobia, pacemaker, estimated GFR lower or equal to 50mls/min)
- Contraindication to prostate biopsy
About this study
Official title: Fully Hybrid 18F-PSMA PET/MRI as One-stop Approach for the Diagnosis of Clinically Significant Prostate Cancer
This project aims to evaluate the role of fully hybrid PET/MRI with 18F-PSMA and multiparametric MR imaging (mpMRI) as one-stop approach for the diagnosis of clinically significant prostate cancer (csPCa).
This prospective PET/MRI clinical evaluation will ideally reduce the number of false negative findings, while at the same time, allowing also to reduce the number of unnecessary prostate biopsies in patients with low-risk, clinically indolent PCa.
The demonstration that, compared to mpMRI alone, the use of PET/MRI with 18F-PSMA has a superior diagnostic accuracy in detecting men with csPCa will strongly support the inclusion of 18F-PSMA as pre-biopsy triage test, in addition to mpMRI in daily clinical practice.
- Conditions
- Prostate Cancer
- Being tested
- 18F-PSMA-1007
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-PSMA-1007Drug
(3S, 10S, 14S)-1-[4-[[(2S)-4-carboxy-3-[(2S)-4-carboxy-2-(6-[18F]fluoropyridin-3- amido)butanamido]butanamido]methyl]phenyl]-3- [(naphtalen-2-yl)methyl]-1,4,12-trioxo-2,5,11,13-tetraazahexadecane- 10,14,16-tricarboxilyc acid
| Study group | Role | What they receive |
|---|---|---|
| 18F-PSMA-1007 | Experimental | All patients undergo the same experimental procedure Receives: Drug: 18F-PSMA-1007 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the accuracy and the predictive value of fully hybrid 18F-PSMA PET/MRI for the diagnosis of csPCa
Diagnostic accuracy measured with sensitivity, specificity, positive and negative predicted value
Measured: Biopsy at day 90 (+/-90)
To compare the proportion of csPCa missed by 18F-PSMA PET scan or mpMRI alone
The number of csPCa missed by PET and MR imaging when read independently
Measured: Biopsy at day 90 (+/-90)
To report the change in the detection of clinically insignificant PCa when combining mpMRI and 18F-PSMA PET, and consequently the proportion of unnecessary biopsies potentially spared.
Only in patients with positive mpMRI and negative 18F-PSMA PET: The proportion of clinically insignificant PCa
Measured: Biopsy at day 90 (+/-90)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start30 Apr 2023 (estimated)
- Primary completion31 Jul 2025 (estimated)
- Study completion29 Apr 2026 (estimated)
Why it stopped: error in the registration on clincialtrials.gov. The same clinical trial has been correctly registered with the identifier NCT 06305390
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Picchio, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05815316
- Sponsor's protocol ID
- RF-2021-12372278
- Status last verified
- Apr 2025
- First submitted
- 21 Mar 2023
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fully Hybrid 18F-PSMA PET/MRI as One-stop Approach for the Diagnosis of Clinically Significant Prostate Cancer
- ClinicalTrials.gov ID
- NCT05815316
- Acronym / sponsor ID
- RF-2021-12372278
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: error in the registration on clincialtrials.gov. The same clinical trial has been correctly registered with the identifier NCT 06305390
- Enrolment
- 0 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 30 Apr 2023 (estimated)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 29 Apr 2026 (estimated)
- First posted
- 18 Apr 2023 (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 project aims to evaluate the role of fully hybrid PET/MRI with 18F-PSMA and multiparametric MR imaging (mpMRI) as one-stop approach for the diagnosis of clinically significant prostate cancer (csPCa).
This prospective PET/MRI clinical evaluation will ideally reduce the number of false negative findings, while at the same time, allowing also to reduce the number of unnecessary prostate biopsies in patients with low-risk, clinically indolent PCa.
The demonstration that, compared to mpMRI alone, the use of PET/MRI with 18F-PSMA has a superior diagnostic accuracy in detecting men with csPCa will strongly support the inclusion of 18F-PSMA as pre-biopsy triage test, in addition to mpMRI in daily clinical practice.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18F-PSMA-1007 | Experimental | Drug: 18F-PSMA-1007All patients undergo the same experimental procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men at least 18 years of age referred with clinical suspicion of prostate cancer candidate for prostate biopsy
- Feasibility to undergo all procedures listed in protocol
- Ability to provide written informed consent
Key exclusion criteria (3 listed)
- Prior diagnosis of prostate cancer
- Contraindication to MRI (e.g. claustrophobia, pacemaker, estimated GFR lower or equal to 50mls/min)
- Contraindication to prostate 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 |
|---|---|---|
| 18F-PSMA-1007(3S, 10S, 14S)-1-[4-[[(2S)-4-carboxy-3-[(2S)-4-carboxy-2-(6-[18F]fluoropyridin-3- amido)butanamido]butanamido]methyl]phenyl]-3- [(naphtalen-2-yl)methyl]-1,4,12-trioxo-2,5,11,13-tetraazahexadecane- 10,14,16-tricarboxilyc acid | Drug | 18F-PSMA-1007 |
Primary outcome
To assess the accuracy and the predictive value of fully hybrid 18F-PSMA PET/MRI for the diagnosis of csPCa
Time frame: Biopsy at day 90 (+/-90)
Diagnostic accuracy measured with sensitivity, specificity, positive and negative predicted value
To compare the proportion of csPCa missed by 18F-PSMA PET scan or mpMRI alone
Time frame: Biopsy at day 90 (+/-90)
The number of csPCa missed by PET and MR imaging when read independently
To report the change in the detection of clinically insignificant PCa when combining mpMRI and 18F-PSMA PET, and consequently the proportion of unnecessary biopsies potentially spared.
Time frame: Biopsy at day 90 (+/-90)
Only in patients with positive mpMRI and negative 18F-PSMA PET: The proportion of clinically insignificant PCa
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 18F-PSMA-1007 in people with Prostate Cancer, run by IRCCS San Raffaele.
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 3 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: withdrawn, as of the sponsor's last update on 13 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the accuracy and the predictive value of fully hybrid 18F-PSMA PET/MRI for the diagnosis of csPCa (time frame: Biopsy at day 90 (+/-90)). The study lists 3 primary outcomes in all. 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 13 Apr 2025.