Prostate CancerPSMA-PROSTAPETNCT04462926
Evaluation of Diagnostic Accuracy of [68Ga]Ga-PSMA-11 PET/CT in Primary Staging of Intermediate and High Risk Prostatic Cancer in Men Newly Diagnosed
A study testing [68Ga]Ga-PSMA-11 PET/CT in people with Prostate Cancer and Prostatic Neoplasm, run by Azienda Ospedaliero-Universitaria di Modena at 1 site in Italy.
Trial summary
This is a diagnostic accuracy prospective, single-centre, open-label, single group assignment interventional study. Its aim is to evaluate the diagnostic accuracy of [68Ga]Ga-PSMA-11 PET/CT in detection of primary tumour and extra prostatic disease (lymph node, soft tissues spread or bone metastases) in men newly… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Prostatic Neoplasm, Urogenital Neoplasms
- What is being tested?
- [68Ga]Ga-PSMA-11 PET/CT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 20 Sep 2020to 20 Sep 2024
- Phase
- Interventional
- 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 with histo-pathological confirmation of PCa with intermediate or high-risk disease according to 2019 Prostate Cancer EAU Guidelines Risk Group Stratification (see Study Population paragraph)
- Patients with conventional imaging mpMRI (with or without CT of the lower abdomen and Bone scan) performed as baseline in primary PCa staging according to 2019 Prostate Cancer EAU Guidelines
- Age >18 years/old
- Ability to provide written informed consent
Who cannot join
- Contra-indication for PET/CT scan: Patients not capable of getting PET study due to weight, claustrophobia, or inability to lay still for the duration of the exam
- Impaired renal function
- Impaired liver function: AST or ALT > 2.5 x ULN
- Patients unable to understand the purpose of the study
- Medical history of allergic reactions or hypersensitivity to [68Ga] Ga-PSMA-11 as well as to any excipient or component of the experimental medicinal product
- Having partecipated in clinical trial in which the experimental intervention was administered within 30 days (or 5 half-life) from administration the endovenous solution of [68Ga]Ga-PSMA-11
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedaliero-Universitaria di Modena
Modena, 41124
Pietro Ghedini, MD, 0594225167, ghedini.pietro@aou.mo.it
Antonella Franceschetto, MD
About this study
This is a diagnostic accuracy prospective, single-centre, open-label, single group assignment interventional study.
Its aim is to evaluate the diagnostic accuracy of [68Ga]Ga-PSMA-11 PET/CT in detection of primary tumour and extra prostatic disease (lymph node, soft tissues spread or bone metastases) in men newly diagnosed with Prostate Cancer at Intermediate and High Risk, according to 2019 Prostate Cancer EAU Guidelines Risk Group Stratification (see Study Population paragraph).
The investigators are interested in the possible future role of [68Ga]Ga-labelled PSMA PET/CT as integration to conventional imaging mpMRI (with or without CT of the lower abdomen and Bone scan) in the detection of primary tumor and extra-prostatic disease (lymph node and soft tissues spread or bone metastases).
Read the detailed description
This is a diagnostic accuracy prospective, single-centre, open-label, single group assignment interventional study.
The primary objective of this study is to evaluate the diagnostic accuracy of [68Ga]Ga-PSMA-11 PET/CT in detection of primary tumor and extraprostatic disease (lymph node, soft tissues spread or bone metastases) in men newly diagnosed with prostate cancer at intermediate or high-risk.
The secondary objective of this study is to compare the diagnostic accuracy of [68Ga]Ga-PSMA-11 PET/CT to the diagnostic accuracy of conventional imaging mpMRI (with or without CT of the lower abdomen and Bone scan) in the prostatic bed and extra prostatic disease in men newly diagnosed with prostate cancer at intermediate or high-risk.
To evaluate association between [68Ga]Ga-PSMA-11 PET/CT uptake value (SUVmax and SUVmean) and aggressiveness of prostate tumor (e.g. PSA serum level and Gleason Score).
- Conditions
- Prostate Cancer, Prostatic Neoplasm, Urogenital Neoplasms, Prostatic Disease, Disease Attributes, Neoplasms
- Being tested
- [68Ga]Ga-PSMA-11 PET/CT
- Keywords
- 68GaPSMA PET/CT, Prostate cancer, primary staging
- Medical subject headings
- Prostatic Neoplasms, Urogenital Neoplasms, Prostatic Diseases, Disease Attributes, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[68Ga]Ga-PSMA-11 PET/CTDiagnostic test
1.8-2.2 MBq (0.049-0.060 mCi) per kilogram bodyweight will be injected intravenously prior to perform the PET/CT
| Study group | Role | What they receive |
|---|---|---|
| [68Ga]Ga-PSMA-11 PET/CT | Experimental | 1.8-2.2 MBq (0.049-0.060 mCi) per kilogram bodyweight will be injected intravenously prior to perform the PET/CT Receives: Diagnostic Test: [68Ga]Ga-PSMA-11 PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy measures (sensitivity, specificity, positive and negative predictive values) of [68Ga]Ga-PSMA-11 PET/CT in detection of primary tumor and extraprostatic disease (lymph node, soft tissues spread or bone metastases).
For the primary objective, the following index test and reference test will be considered:
Index test: [68Ga]Ga-PSMA-11 PET/CT performed before treatment. Reference test: clinical, radiological and histo-pathologic assessment, when available, at 12 months followup and up to 24 months after treatment.
Two nuclear medicine physicians will review the PET images using PET/CT Software Syngo.via.
A PET positive finding for pelvic or retroperitoneal lymph nodes or lymph nodes ≥ 8mm is defined with PSMA uptake equal to or above blood pool and lower than liver.
A PET positive finding in lymph nodes of other regions is defined with PSMA uptake equal to or above liver and lower than parotid gland. Any uptake equal to or above parotid gland will be considered positive.
The readers will be blinded to clinical and pathologic data, except for the knowledge of diagnosis of biopsy proven prostate cancer.
Measured: Up to 24 months after treatment
Secondary outcomes (1)
Comparation diagnostic accuracy of the [68Ga]Ga-PSMA-11 PET/CT versus the conventional imaging mpMRI (with or without CT of the lower abdomen and Bone scan) in the prostatic bed and extra prostatic disease.
For the secondary objective, the following index test and reference test will be considered:
Index test: conventional imaging mpMRI performed before treatment. Reference test: clinical, radiological and histo-pathologic assessment at 12 months follow-up and up to 24 months after treatment.
MRI imaging results will be evaluated by two radiologists specializing in body MRI imaging with the PI-RADS version 2 criteria.
In addition, for the secondary objective, after testing the assumption of normality with the Kolmogorov-Smirnov test, the metabolic PET parameters (SUV max and SUV mean) will be correlated with PSA serum level, by using the Pearson correlation, and with Gleason score and tumor volume, by using the Spearman correlation.
Measured: Up to 24 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start20 Sep 2020 (estimated)
- Primary completion20 Sep 2024 (estimated)
- Study completion20 Sep 2024 (estimated)
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.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria di Modena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonella Franceschetto, Azienda Ospedaliero-Universitaria di Modena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04462926
- Sponsor's protocol ID
- ND
- Other IDs
- 2019-004685-18, 2019
- Acronym
- PSMA-PROSTAPET
- Status last verified
- Sep 2020
- First submitted
- 26 Jun 2020
- Last updated
- 17 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Diagnostic Accuracy of [68Ga]Ga-PSMA-11 PET/CT in Primary Staging of Intermediate and High Risk Prostatic Cancer in Men Newly Diagnosed
- ClinicalTrials.gov ID
- NCT04462926
- Acronym / sponsor ID
- PSMA-PROSTAPET / ND
- Conditions
- Prostate Cancer, Prostatic Neoplasm, Urogenital Neoplasms, Prostatic Disease, Disease Attributes, Neoplasms
- Keywords
- 68GaPSMA PET/CT, Prostate cancer, primary staging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Azienda Ospedaliero-Universitaria di ModenaUniversity, hospital or other
- Study start
- 20 Sep 2020 (estimated)
- Primary completion
- 20 Sep 2024 (estimated)
- Study completion
- 20 Sep 2024 (estimated)
- First posted
- 8 Jul 2020 (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 is a diagnostic accuracy prospective, single-centre, open-label, single group assignment interventional study.
Its aim is to evaluate the diagnostic accuracy of [68Ga]Ga-PSMA-11 PET/CT in detection of primary tumour and extra prostatic disease (lymph node, soft tissues spread or bone metastases) in men newly diagnosed with Prostate Cancer at Intermediate and High Risk, according to 2019 Prostate Cancer EAU Guidelines Risk Group Stratification (see Study Population paragraph).
The investigators are interested in the possible future role of [68Ga]Ga-labelled PSMA PET/CT as integration to conventional imaging mpMRI (with or without CT of the lower abdomen and Bone scan) in the detection of primary tumor and extra-prostatic disease (lymph node and soft tissues spread or bone metastases).
Detailed description
This is a diagnostic accuracy prospective, single-centre, open-label, single group assignment interventional study.
The primary objective of this study is to evaluate the diagnostic accuracy of [68Ga]Ga-PSMA-11 PET/CT in detection of primary tumor and extraprostatic disease (lymph node, soft tissues spread or bone metastases) in men newly diagnosed with prostate cancer at intermediate or high-risk.
The secondary objective of this study is to compare the diagnostic accuracy of [68Ga]Ga-PSMA-11 PET/CT to the diagnostic accuracy of conventional imaging mpMRI (with or without CT of the lower abdomen and Bone scan) in the prostatic bed and extra prostatic disease in men newly diagnosed with prostate cancer at intermediate or high-risk.
To evaluate association between [68Ga]Ga-PSMA-11 PET/CT uptake value (SUVmax and SUVmean) and aggressiveness of prostate tumor (e.g. PSA serum level and Gleason Score).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [68Ga]Ga-PSMA-11 PET/CT | Experimental | Diagnostic Test: [68Ga]Ga-PSMA-11 PET/CT1.8-2.2 MBq (0.049-0.060 mCi) per kilogram bodyweight will be injected intravenously prior to perform the PET/CT |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with histo-pathological confirmation of PCa with intermediate or high-risk disease according to 2019 Prostate Cancer EAU Guidelines Risk Group Stratification (see Study Population paragraph)
- Patients with conventional imaging mpMRI (with or without CT of the lower abdomen and Bone scan) performed as baseline in primary PCa staging according to 2019 Prostate Cancer EAU Guidelines
- Age >18 years/old
- Ability to provide written informed consent
Key exclusion criteria (6 listed)
- Contra-indication for PET/CT scan: Patients not capable of getting PET study due to weight, claustrophobia, or inability to lay still for the duration of the exam
- Impaired renal function
- Impaired liver function: AST or ALT > 2.5 x ULN
- Patients unable to understand the purpose of the study
- Medical history of allergic reactions or hypersensitivity to [68Ga] Ga-PSMA-11 as well as to any excipient or component of the experimental medicinal product
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 |
|---|---|---|
| [68Ga]Ga-PSMA-11 PET/CT1.8-2.2 MBq (0.049-0.060 mCi) per kilogram bodyweight will be injected intravenously prior to perform the PET/CT | Diagnostic test | [68Ga]Ga-PSMA-11 PET/CT |
Primary outcome
Diagnostic accuracy measures (sensitivity, specificity, positive and negative predictive values) of [68Ga]Ga-PSMA-11 PET/CT in detection of primary tumor and extraprostatic disease (lymph node, soft tissues spread or bone metastases).
Time frame: Up to 24 months after treatment
For the primary objective, the following index test and reference test will be considered: Index test: [68Ga]Ga-PSMA-11 PET/CT performed before treatment. Reference test: clinical, radiological and histo-pathologic assessment, when available, at 12 months followup and up to 24 months after treatment. Two nuclear medicine physicians will review the PET images using PET/CT Software Syngo.via. A PET positive finding for pelvic or retroperitoneal lymph nodes or lymph nodes ≥ 8mm is defined with PSMA uptake equal to or above blood pool and lower than liver. A PET positive finding in lymph nodes of other regions is defined with PSMA uptake equal to or above liver and lower than parotid gland. Any uptake equal to or above parotid gland will be considered positive. The readers will be blinded to clinical and pathologic data, except for the knowledge of diagnosis of biopsy proven prostate cancer.
1 secondary outcome
Comparation diagnostic accuracy of the [68Ga]Ga-PSMA-11 PET/CT versus the conventional imaging mpMRI (with or without CT of the lower abdomen and Bone scan) in the prostatic bed and extra prostatic disease.
Time frame: Up to 24 months after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2020.
- Individual participant dataSharing planned: Undecided. Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing [68Ga]Ga-PSMA-11 PET/CT in people with Prostate Cancer and Prostatic Neoplasm, run by Azienda Ospedaliero-Universitaria di Modena 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 6 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: status not confirmed, as of the sponsor's last update on 17 Sep 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pietro Ghedini, MD (0594225167, ghedini.pietro@aou.mo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy measures (sensitivity, specificity, positive and negative predictive values) of [68Ga]Ga-PSMA-11 PET/CT in detection of primary tumor and extraprostatic disease (lymph node, soft tissues spread or bone metastases). (time frame: Up to 24 months after treatment). 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 17 Sep 2020.