18F-PSMAPhase 2F-PSMANCT04775602
Experimental Study to Evaluate the Impact of 18 Fluoro-PSMA (18F-PSMA) PET / CT in the Management of Patients with Prostate Cancer.
A Phase 2 study testing 18F-PSMA in people with 18F-PSMA and Prostate Cancer, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS at 1 site in Italy.
Trial summary
Single-center, prospective, open-label, not randomized, diagnostic phase II trial in the management of patients with prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- 18F-PSMA, Prostate Cancer
- What is being tested?
- 18F-PSMA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 550 participants
- Where
- 1 siteItaly
- Study dates
- 31 Jul 2020to 11 Jul 2024
- 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
- Patients must have histologically or cytologically confirmed prostate cancer
- Male, aged >18 years on the day of signing and dating the informed consent form.
- Previous radical treatment for prostate cancer (radiotherapy or surgery)
- Negativity of all the other traditional morphological and functional imaging or doubtful imaging of 18F-FMC PET/CT
- Patients with PSA progression defined as PSA ≥ 0.2 ng/mL and PSA rising defined as 2 subsequent values showing PSA increase at least 1 week apart.
- Male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 3 months thereafter
- Participant is willing and able to give informed consent for participation in the study.
Who cannot join
- Hormonotherapy in the last 6 months
- No radiotherapy in the last 6 months.
- Participation in another clinical trial with any investigational agents within 30 days prior to prior informed consent date
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Study Agent.
- Medical or psychological conditions that would not permit the subject to sign the informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Experimental Study to Evaluate the Impact of 18F-PSMA PET / CT in the Management of Patients with Prostate Cancer.
Single-center, prospective, open-label, not randomized, diagnostic phase II trial in the management of patients with prostate cancer.
Read the detailed description
Single-center, prospective, open-label, not randomized, diagnostic phase II trial in the management of patients with prostate cancer. The aim of this study is to evaluate the additional diagnostic role of 18F- PSMA PET /CT (sensitivity) in patients with prostate cancer with biochemical relapse compared to other diagnostic methods routinely used. The primary objective is to evaluate the sensitivity of 18F-PSMA PET/CT defined as the ratio between the number of 18F-PSMA PET/CT positive patients and the number of prostate cancer patients with biochemical relapse and negative standard imaging.Patients enrolled in the study would benefit from a more accurate but above all earlier diagnosis of disease recurrence sites, thus being able to undergo targeted therapies, with a clear impact on the clinical management of the disease.
- Conditions
- 18F-PSMA, Prostate Cancer
- Being tested
- 18F-PSMA
- Keywords
- 18F-PSMA, PET/CT, Prostate Cancer, Diagnostic, Biochemical relapse, Negative standard imaging, Radically treated
- Medical subject headings
- Prostatic Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-PSMADrug
18F-PSMA will be injected intravenously at a dosage of 200-250 megabecquerel (MBq) prior to perform Image acquisition (Topogram, CT, PET)
| Study group | Role | What they receive |
|---|---|---|
| 18F-PSMA PET/CT | Experimental | Patients with evidence of biochemical recurrence of prostate cancer radically treated, with negative results to traditional diagnostic methods or doubtful imaging of 18F- Fluoro Methyl Choline (18F-FMC) PET/CT will perform a 18F-PSMA PET/CT as a tool for searching and location of recurrence. Receives: Drug: 18F-PSMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic role of 18F- PSMA PET /CT (sensitivity)
Sensitivity of 18F-PSMA PET/CT will be calculated as the ratio between the number of 18F- PSMA PET/CT positive patients and number of patients with radically treated prostate cancer with biochemical relapse and negativity of traditional morphological imaging.
Measured: Up to 30 months
Secondary outcomes (5)
Sensitivity for different PSA values (ranges)
Sensitivity of 18F-PSMA PET/CT will be stratified respect to different ranges of Prostate-Specific Antigen (PSA) values.
Measured: Up to 30 months
Sensitivity for different lesion sites
Sensitivity of 18F-PSMA PET/CT will be stratified respect to different sites of lesion.
Measured: Up to 30 months
predictive role of 18F-PSMA PET/CT on disease status according to standard imaging and PSA evaluation.
To evaluate the predictive role of 18F-PSMA PET/CT on disease status, for patients that will start an anticancer treatment. It will be performed the receiver operating characteristic (ROC) curves generated by plotting sensitivity versus 1-specificity The best cut-off value for distinguishing between positive and negative 18F- PSMA PET/CT findings will be determined using Youden's index.
Measured: Up to 30 months
evaluation of the concordance between 18F-PSMA PET/CT and other methods
To evaluate the concordance between 18F-PSMA PET/CT and PET/CT or the others standard methods, for patients without any treatment, it will be performed by Cohen's kappa coefficient
Measured: Up to 30 months
18F-PSMA Safety: treated patients undergoing grade 1 to 4 adverse event
Number and percentage of treated patients undergoing grade 1 to 4 adverse events will be tabulated according to CTCAE version 5.0.
Measured: Up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study start31 Jul 2020
- Primary completion5 Apr 2023
- Study completion11 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 18F-PSMAStudies 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 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 550 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Federica Matteucci, MD, Principal investigator, IRST IRCCS, Meldola (FC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04775602
- Sponsor's protocol ID
- IRST185.07
- Other IDs
- 2019-002000-41, 2019
- Acronym
- F-PSMA
- Status last verified
- Jan 2025
- First submitted
- 21 Jan 2020
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experimental Study to Evaluate the Impact of 18F-PSMA PET / CT in the Management of Patients with Prostate Cancer.
- ClinicalTrials.gov ID
- NCT04775602
- Acronym / sponsor ID
- F-PSMA / IRST185.07
- Conditions
- 18F-PSMA, Prostate Cancer
- Keywords
- 18F-PSMA, PET/CT, Prostate Cancer, Diagnostic, Biochemical relapse, Negative standard imaging, Radically treated
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 550 participants (actual)
- Lead sponsor
- Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCSUniversity, hospital or other
- Study start
- 31 Jul 2020 (actual)
- Primary completion
- 5 Apr 2023 (actual)
- Study completion
- 11 Jul 2024 (actual)
- First posted
- 1 Mar 2021 (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.
Single-center, prospective, open-label, not randomized, diagnostic phase II trial in the management of patients with prostate cancer.
Detailed description
Single-center, prospective, open-label, not randomized, diagnostic phase II trial in the management of patients with prostate cancer. The aim of this study is to evaluate the additional diagnostic role of 18F- PSMA PET /CT (sensitivity) in patients with prostate cancer with biochemical relapse compared to other diagnostic methods routinely used. The primary objective is to evaluate the sensitivity of 18F-PSMA PET/CT defined as the ratio between the number of 18F-PSMA PET/CT positive patients and the number of prostate cancer patients with biochemical relapse and negative standard imaging.Patients enrolled in the study would benefit from a more accurate but above all earlier diagnosis of disease recurrence sites, thus being able to undergo targeted therapies, with a clear impact on the clinical management of the disease.
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 PET/CT | Experimental | Drug: 18F-PSMAPatients with evidence of biochemical recurrence of prostate cancer radically treated, with negative results to traditional diagnostic methods or doubtful imaging of 18F- Fluoro Methyl Choline (18F-FMC) PET/CT will perform a 18F-PSMA PET/CT as a tool for searching and location of recurrence. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients must have histologically or cytologically confirmed prostate cancer
- Male, aged >18 years on the day of signing and dating the informed consent form.
- Previous radical treatment for prostate cancer (radiotherapy or surgery)
- Negativity of all the other traditional morphological and functional imaging or doubtful imaging of 18F-FMC PET/CT
- Patients with PSA progression defined as PSA ≥ 0.2 ng/mL and PSA rising defined as 2 subsequent values showing PSA increase at least 1 week apart.
Key exclusion criteria (5 listed)
- Hormonotherapy in the last 6 months
- No radiotherapy in the last 6 months.
- Participation in another clinical trial with any investigational agents within 30 days prior to prior informed consent date
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Study Agent.
- Medical or psychological conditions that would not permit the subject to sign the informed consent
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-PSMA18F-PSMA will be injected intravenously at a dosage of 200-250 megabecquerel (MBq) prior to perform Image acquisition (Topogram, CT, PET) | Drug | 18F-PSMA PET/CT |
Primary outcome
Diagnostic role of 18F- PSMA PET /CT (sensitivity)
Time frame: Up to 30 months
Sensitivity of 18F-PSMA PET/CT will be calculated as the ratio between the number of 18F- PSMA PET/CT positive patients and number of patients with radically treated prostate cancer with biochemical relapse and negativity of traditional morphological imaging.
5 secondary outcomes
Sensitivity for different PSA values (ranges)
Time frame: Up to 30 months
Sensitivity for different lesion sites
Time frame: Up to 30 months
predictive role of 18F-PSMA PET/CT on disease status according to standard imaging and PSA evaluation.
Time frame: Up to 30 months
evaluation of the concordance between 18F-PSMA PET/CT and other methods
Time frame: Up to 30 months
18F-PSMA Safety: treated patients undergoing grade 1 to 4 adverse event
Time frame: Up to 30 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
- Individual participant dataSharing planned: Undecided
Related trials for 18F-PSMA
RecruitingPhase 4
Impact of Fluciclovine (18F) PET (Positron Emission Tomography) on the Management of Prostate Cancer Following Negative or Equivocal PSMA (Prostate-Specific Membrane Antigen) PET Imaging at the Time of Biochemical Recurrence
Prostate Cancer
Not yet recruiting
POSLUMA PET Imaging for PI-RADS 3 Prostate Lesions
Prostate Cancer, PI-RADS 3 Prostate Lesion
Active, not recruitingPhase 2
18F-DCFPyL PET/CT in High Risk and Recurrent Prostate Cancer
Prostate Neoplasms, Prostatic Cancer
Active, not recruitingPhase 2
18F-DCFPyL PSMA- Versus 18F-NaF-PET Imaging for Detection of Metastatic Prostate Cancer
Metastatic Prostate Cancer, Prostatic Neoplasms
RecruitingPhase 1
Pilot Study for Detection of PSMA-Low CRPC-NE Tumors With Fluciclovine PET/CT
Advanced Prostate Cancer, Metastatic Prostate Cancer
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.
Federica Matteucci, MD principal investigator
IRST IRCCS, Meldola (FC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 18F-PSMA in people with 18F-PSMA and Prostate Cancer, run by Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. 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 7 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: finished, as of the sponsor's last update on 9 Jan 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.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Diagnostic role of 18F- PSMA PET /CT (sensitivity) (time frame: Up to 30 months). 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 9 Jan 2025.