Prostate CancerNCT03174054
The Value of PSMA-PET Compared With Multi-parametric MRI in the Detection Prostate Lesions
An observational study of Prostate Cancer, run by Assuta Medical Center.
Trial summary
Prostate cancer is a common disease in men. In prostate 35% of biopsies, usually done due to increased PSA levels or clinical suspicion, are false negative, despite malignancy. Multi-parametric prostate MRI detects malignant neoplasm lesions better than other imaging devices. Read more about this study
- Who is it for?
- Ages 40 to 95 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2017to 1 Jun 2019
- Phase
- Observational
- 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 40 to 95 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Men aged 40 and over,with clinical suspicion of prostate cancer, referred for multi parametric MRI .
Who may be able to join
- Men aged 40 and over.
- Patients with clinical suspicion of prostate cancer, referred for multi parametric MRI
Who cannot join
- Are unable to perform multi-parameter MRI (eg GFR below 30, metals in the body, claustrophobia, etc.).
- Can not / want to sign informed consent form.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of the Added Value of PSMA-PET Compared With Multi-parametric MRI in the Detection and Classification of Prostate Lesions
Prostate cancer is a common disease in men. In prostate 35% of biopsies, usually done due to increased PSA levels or clinical suspicion, are false negative, despite malignancy.
Multi-parametric prostate MRI detects malignant neoplasm lesions better than other imaging devices.
Read more
A sonar-guided prostate biopsy based on multi-parametric MRI images improves detection of malignancy. Ga68 PSMA-PET test uses a radioactive marker that binds to the prostate's cells and is shown to be a primary prostate tumor site in addition to metastasis.
We believe that the combination of measures from a single Ga68 PSMA and multi-parametric MRI test can lead to further improvement in malignancy, better biopsy guidance, and optimal treatment for the patient.
Read the detailed description
Prostate cancer is the most common and second leading cause of cancer death in men.
Mostly, patients undergo prostate biopsy whenever abnormal digital rectal examination or elevated prostate specific antigen (PSA) levels have been found. Traditionally, trans-rectal US (TRUS) biopsy is performed using 10-12 needles that are inserted into different areas of the prostate gland. Despite this, up to 35% of prostate cancers are still not diagnosed.
The use of multi-parametric prostate MRI (mnMRI) in which T2-weighted sequence, diffusion weighted imaging (DWI) and dynamic contrast enhanced-imaging (DCE) are used has shown to increase the cancer detection rate of clinically significant lesions and better stratify prostate cancer compared to other modalities(3). A pre-biopsy mnMR can identify suspicious lesions that can be targeted on biopsy. Indeed, the use of MRI- US fusion in which pre-biopsy MR images are incorporated with real time biopsy US images has shown to reduce the number of biopsies performed on patients with low grade cancer and increase the detection of intermediate-high risk subgroups of patients(4).
The introduction of PET/MR with the use of PSMA as a radiotracer offers the potential to add a new biomarker to the well-established mnMRI. Different PSMA metrics such as SUV, metabolic tumor volume (MTV) and kinetic parameters can be correlated with lesion detection rate and Gleason score and help tailoring the precise treatment to patients.
The purpose of the current study is to reveal if PSMA-PET has an added value in the detection and stratification of prostate cancer to the currently used nmMRI.
First Objective: To examine whether PSMA-PET increases detection sensitivity and allows better classification of prostate lesions.
Secondary objective: To check the correlation between PSMA-PET measurements and the various indices of multi-parametrial MRI and the histological results.
The work hypothesis: The PSMA PET MRI measurements will improve the ability to identify and classify prostate lesions and conform to the various MRI measurements Research Methods-
The study population:
Patients who have a clinical suspicion of prostate cancer that will be referred to the prostate multi-parameter MRI before deciding on a prostate biopsy Sampling Method: The study is prospective and will include subjects who meet the criteria for inclusion in a continuous manner. The subjects will undergo a PET MRI PSMA test, followed by a prostate fusion biopsy (up to two weeks after the test) using US fusion technology.
Parameters of the PSMA PET-MR test :
PET Measurements: Quantitative calculation of the absorption of suspicious lesions.
The type of biopsy will depend on the PET MRI results. If a suspicious finding is found according to the PET or MR test or both, the biopsy will be done using the US FUSION MRI, and if a suspicious lesion is not seen, the biopsy will be performed by sonar alone, or not at all.
Sample size: 70 participants.
- Conditions
- Prostate Cancer
- Being tested
- Biopsy
- Keywords
- Men aged 40 and over, multi parametric MRI
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiopsyProcedure or surgery
Biopsies are part of standard procedures in the patients recruited and will not be done due to this study.
| Study group | Role | What they receive |
|---|---|---|
| Patients with no clear lesion in PET or MRI | If the clinical suspicion of cancer is low, there will be no biopsy, only follow-up. If the decision is to perform a biopsy on the prostate, it will be performed with transrectal sonar guidance and systematic biopsies will be performed (12 samples will be taken from different areas of the prostate) | |
| Patients with MRI lesions and overlapping mapping lesions | If MRI and PET are matched, a US FUSION MRI biopsy will be taken between 4-8 samples directly from the lesion as well as other systemic prostate samples according to the surgeon's decision. Will be taken and sent separately to pathology. Receives: Procedure: Biopsy | |
| Patients with a discrepancy between the PET and MRI | A FUSION approach will be biopsy. Four to eight samples for each lesion, as well as other systemic prostate samples will be taken according to the surgeon's decision, and the samples will be marked and sent separately to the pathology. Receives: Procedure: Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation between SUV to PSA levels.
PET Measurements vs. clinical measurements
Measured: 24 months in relation to each patient baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2017
- Study start1 Jun 2017 (estimated)
- Primary completion1 Jan 2019 (estimated)
- Study completion1 Jun 2019 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assuta Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, david groshar, Assuta Medical Center
- Investigators
- David Groshar, MD, Principal investigator, Head of nuclear medicine unit in Assuta Medical Centers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03174054
- Sponsor's protocol ID
- 0132-16
- Status last verified
- Jun 2017
- First submitted
- 18 Apr 2017
- Last updated
- 2 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- 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 2 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Added Value of PSMA-PET Compared With Multi-parametric MRI in the Detection and Classification of Prostate Lesions
- ClinicalTrials.gov ID
- NCT03174054
- Acronym / sponsor ID
- 0132-16
- Conditions
- Prostate Cancer
- Keywords
- Men aged 40 and over, multi parametric MRI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assuta Medical CenterUniversity, hospital or other
- Study start
- 1 Jun 2017 (estimated)
- Primary completion
- 1 Jan 2019 (estimated)
- Study completion
- 1 Jun 2019 (estimated)
- First posted
- 2 Jun 2017 (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.
Prostate cancer is a common disease in men. In prostate 35% of biopsies, usually done due to increased PSA levels or clinical suspicion, are false negative, despite malignancy.
Multi-parametric prostate MRI detects malignant neoplasm lesions better than other imaging devices.
A sonar-guided prostate biopsy based on multi-parametric MRI images improves detection of malignancy. Ga68 PSMA-PET test uses a radioactive marker that binds to the prostate's cells and is shown to be a primary prostate tumor site in addition to metastasis.
We believe that the combination of measures from a single Ga68 PSMA and multi-parametric MRI test can lead to further improvement in malignancy, better biopsy guidance, and optimal treatment for the patient.
Detailed description
Prostate cancer is the most common and second leading cause of cancer death in men.
Mostly, patients undergo prostate biopsy whenever abnormal digital rectal examination or elevated prostate specific antigen (PSA) levels have been found. Traditionally, trans-rectal US (TRUS) biopsy is performed using 10-12 needles that are inserted into different areas of the prostate gland. Despite this, up to 35% of prostate cancers are still not diagnosed.
The use of multi-parametric prostate MRI (mnMRI) in which T2-weighted sequence, diffusion weighted imaging (DWI) and dynamic contrast enhanced-imaging (DCE) are used has shown to increase the cancer detection rate of clinically significant lesions and better stratify prostate cancer compared to other modalities(3). A pre-biopsy mnMR can identify suspicious lesions that can be targeted on biopsy. Indeed, the use of MRI- US fusion in which pre-biopsy MR images are incorporated with real time biopsy US images has shown to reduce the number of biopsies performed on patients with low grade cancer and increase the detection of intermediate-high risk subgroups of patients(4).
The introduction of PET/MR with the use of PSMA as a radiotracer offers the potential to add a new biomarker to the well-established mnMRI. Different PSMA metrics such as SUV, metabolic tumor volume (MTV) and kinetic parameters can be correlated with lesion detection rate and Gleason score and help tailoring the precise treatment to patients.
The purpose of the current study is to reveal if PSMA-PET has an added value in the detection and stratification of prostate cancer to the currently used nmMRI.
First Objective: To examine whether PSMA-PET increases detection sensitivity and allows better classification of prostate lesions.
Secondary objective: To check the correlation between PSMA-PET measurements and the various indices of multi-parametrial MRI and the histological results.
The work hypothesis: The PSMA PET MRI measurements will improve the ability to identify and classify prostate lesions and conform to the various MRI measurements Research Methods-
The study population:
Patients who have a clinical suspicion of prostate cancer that will be referred to the prostate multi-parameter MRI before deciding on a prostate biopsy Sampling Method: The study is prospective and will include subjects who meet the criteria for inclusion in a continuous manner. The subjects will undergo a PET MRI PSMA test, followed by a prostate fusion biopsy (up to two weeks after the test) using US fusion technology.
Parameters of the PSMA PET-MR test :
PET Measurements: Quantitative calculation of the absorption of suspicious lesions.
The type of biopsy will depend on the PET MRI results. If a suspicious finding is found according to the PET or MR test or both, the biopsy will be done using the US FUSION MRI, and if a suspicious lesion is not seen, the biopsy will be performed by sonar alone, or not at all.
Sample size: 70 participants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with no clear lesion in PET or MRI | – | –If the clinical suspicion of cancer is low, there will be no biopsy, only follow-up. If the decision is to perform a biopsy on the prostate, it will be performed with transrectal sonar guidance and systematic biopsies will be performed (12 samples will be taken from different areas of the prostate) |
| Patients with MRI lesions and overlapping mapping lesions | – | Procedure: BiopsyIf MRI and PET are matched, a US FUSION MRI biopsy will be taken between 4-8 samples directly from the lesion as well as other systemic prostate samples according to the surgeon's decision. Will be taken and sent separately to pathology. |
| Patients with a discrepancy between the PET and MRI | – | Procedure: BiopsyA FUSION approach will be biopsy. Four to eight samples for each lesion, as well as other systemic prostate samples will be taken according to the surgeon's decision, and the samples will be marked and sent separately to the pathology. |
Who may qualify
- Ages
- 40 to 95 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men aged 40 and over,with clinical suspicion of prostate cancer, referred for multi parametric MRI .
Key inclusion criteria (2 listed)
- Men aged 40 and over.
- Patients with clinical suspicion of prostate cancer, referred for multi parametric MRI
Key exclusion criteria (2 listed)
- Are unable to perform multi-parameter MRI (eg GFR below 30, metals in the body, claustrophobia, etc.).
- Can not / want to sign informed consent form.
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 |
|---|---|---|
| BiopsyBiopsies are part of standard procedures in the patients recruited and will not be done due to this study. | Procedure or surgery | Patients with MRI lesions and overlapping mapping lesions, Patients with a discrepancy between the PET and MRI |
Primary outcome
correlation between SUV to PSA levels.
Time frame: 24 months in relation to each patient baseline
PET Measurements vs. clinical measurements
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2017.
- 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.
David Groshar, MD principal investigator
Head of nuclear medicine unit in Assuta Medical Centers
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Assuta Medical Center.
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 2 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: status not confirmed, as of the sponsor's last update on 2 Jun 2017. 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.
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 David Groshar, MD (+972-37645497, davidg@assuta.co.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correlation between SUV to PSA levels. (time frame: 24 months in relation to each patient baseline). 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 2 Jun 2017.