Prostate CancerPhase 2NCT05141760
18F-PSMA PET and MRI in the Primary Staging of Prostate Cancer Patients
A Phase 2 study testing PSMA-1007 Positron Emission Tomography (PET) scan and 3T Magnetic Resonance Imaging (MRI) in people with Prostate Cancer, run by University of Alberta at 1 site in Canada.
Trial summary
This prospective phase II study assesses the accuracy of second generation prostate specific membrane antigen (PSMA) positron emission tomography (PET; utilizing 18F-PSMA-1007)) and multiparametric magnetic resonance imaging (MRI) for locoregional staging of clinically significant prostate cancer in men undergoing… 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?
- PSMA-1007 Positron Emission Tomography (PET) scan and 3T Magnetic Resonance Imaging (MRI)
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- 10 Feb 2022to 15 Jun 2023
- 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 or their legal medical decision makers will sign an informed consent prior to entering the study.
- Adult patient (≥ 18 years old) with a diagnosis of at least Gleason Grade Group 2 prostate cancer.
- Appropriate staging investigations have been performed prior to the participation in the study (i.e. CT abdomen/pelvis and 99mTc-MDP bone scan)
Who cannot join
- Unable to obtain consent
- Weight >250 kg (weight limitation of scanners)
- Unable to lie flat for 30 minutes to complete the PET or MRI imaging
- Severe claustrophobia precluding image acquisition
- Lack of intravenous access
- Non-MRI compatible pacemaker or hardware
- eGFR < 40 mL/min/1.73 m2 and/or a history of a severe reaction to MRI contrast
- Prior androgen deprivation therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing 18F-PSMA-1007 Positron Emission Tomography and Magnetic Resonance Imaging in the Primary Staging of Prostate Cancer Patients
This prospective phase II study assesses the accuracy of second generation prostate specific membrane antigen (PSMA) positron emission tomography (PET; utilizing 18F-PSMA-1007)) and multiparametric magnetic resonance imaging (MRI) for locoregional staging of clinically significant prostate cancer in men undergoing radical prostatectomy and bilateral pelvic lymph node dissection. The design will be a multicenter validating-paired cohort study using radical prostatectomy and pelvic lymph node dissection as the gold standard comparator. Each patient will undergo both 18F-PSMA-1007 PET and 3T MRI allowing comparison of each imaging modality within each subject. Furthermore, PET and MRI will be compared to standard-of-care imaging techniques (CT abdomen/pelvis and 99mTc-MDP Bone scan).
- Conditions
- Prostate Cancer
- Being tested
- PSMA-1007 Positron Emission Tomography (PET) scan and 3T Magnetic Resonance Imaging (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.
PSMA-1007 Positron Emission Tomography (PET) scan and 3T Magnetic Resonance Imaging (MRI)Diagnostic test
Additional staging PET and MRI scan prior to prostatectomy and lymph node dissection
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor T-staging
Differentiate Unilateral vs. Bilateral Tumor (i.e. T2a vs. T2b), Identify extracapsular extension (T3a) or Seminal vesicle invasion (T3b)
Measured: Through study completion, this is expected to be reviewed within 1 year of imaging
Secondary outcomes (13)
Sensitivity of PSMA-1007 PET
Compare final histology against PSMA-1007 PET
Measured: Through study completion, this is expected to be reviewed within 1 year of imaging
Sensitivity of MRI
Compare final histology against MR imaging
Measured: Through study completion, this is expected to be reviewed within 1 year of imaging
Specificity of PSMA-1007 PET
Compare final histology against PSMA-1007 PET
Measured: Through study completion, this is expected to be reviewed within 1 year of imaging
Specificity of MRI
Compare final histology against MR imaging
Measured: Through study completion, this is expected to be reviewed within 1 year of imaging
Negative Predictive Value of PSMA-1007 PET
Compare final histology against PSMA-1007 PET
Measured: Through study completion, this is expected to be reviewed within 1 year of imaging
Negative Predictive Value of MRI
Compare final histology against MR imaging
Measured: Through study completion, this is expected to be reviewed within 1 year of imaging
Positive Predictive Value of PSMA-1007 PET
Compare final histology against PSMA-1007 PET
Measured: Through study completion, this is expected to be reviewed within 1 year of imaging
Positive Predictive Value of MRI
Compare final histology against MRI
Measured: Through study completion, this is expected to be reviewed within 1 year of imaging
Nodal Staging
Accuracy of nodal disease on PSMA-1007 PET and MRI compared to bone scan + CT
Measured: Through study completion, this is expected to be reviewed within 1 year of imaging
Metastatic Staging
Accuracy of PSMA-1007 PET and MRI compared to bone scan + CT
Measured: Through study completion, this is expected to be reviewed within 1 year of imaging
Longest Tumor diameter
Compare final histology against PSMA-1007 PET and MRI measurements
Measured: Through study completion, this is expected to be reviewed within 1 year of imaging
Identification of dominant lesion
Compare rate of dominant lesion identification of PSMA-1007 PET and MRI against final histology
Measured: Through study completion, this is expected to be reviewed within 1 year of imaging
Identification of non-dominant lesion
Compare rate of non-dominant lesion identification of PSMA-1007 PET and MRI against final histology
Measured: Through study completion, this is expected to be reviewed within 1 year of imaging
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2021
- Study start10 Feb 2022
- Primary completion15 Jun 2023
- Study completion15 Jun 2023
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 University of AlbertaThe 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Urological Association Scholarship Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05141760
- Sponsor's protocol ID
- HREBA.CC-21-0073
- Status last verified
- Jun 2024
- First submitted
- 9 Nov 2021
- Last updated
- 6 Jun 2024
- 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 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing 18F-PSMA-1007 Positron Emission Tomography and Magnetic Resonance Imaging in the Primary Staging of Prostate Cancer Patients
- ClinicalTrials.gov ID
- NCT05141760
- Acronym / sponsor ID
- HREBA.CC-21-0073
- Conditions
- Prostate Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Canadian Urological Association Scholarship Foundation
- Study start
- 10 Feb 2022 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 2 Dec 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.
This prospective phase II study assesses the accuracy of second generation prostate specific membrane antigen (PSMA) positron emission tomography (PET; utilizing 18F-PSMA-1007)) and multiparametric magnetic resonance imaging (MRI) for locoregional staging of clinically significant prostate cancer in men undergoing radical prostatectomy and bilateral pelvic lymph node dissection. The design will be a multicenter validating-paired cohort study using radical prostatectomy and pelvic lymph node dissection as the gold standard comparator. Each patient will undergo both 18F-PSMA-1007 PET and 3T MRI allowing comparison of each imaging modality within each subject. Furthermore, PET and MRI will be compared to standard-of-care imaging techniques (CT abdomen/pelvis and 99mTc-MDP Bone scan).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
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)
- Patients or their legal medical decision makers will sign an informed consent prior to entering the study.
- Adult patient (≥ 18 years old) with a diagnosis of at least Gleason Grade Group 2 prostate cancer.
- Appropriate staging investigations have been performed prior to the participation in the study (i.e. CT abdomen/pelvis and 99mTc-MDP bone scan)
Key exclusion criteria (8 listed)
- Unable to obtain consent
- Weight >250 kg (weight limitation of scanners)
- Unable to lie flat for 30 minutes to complete the PET or MRI imaging
- Severe claustrophobia precluding image acquisition
- Lack of intravenous access
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 |
|---|---|---|
| PSMA-1007 Positron Emission Tomography (PET) scan and 3T Magnetic Resonance Imaging (MRI)Additional staging PET and MRI scan prior to prostatectomy and lymph node dissection | Diagnostic test | – |
Primary outcome
Tumor T-staging
Time frame: Through study completion, this is expected to be reviewed within 1 year of imaging
Differentiate Unilateral vs. Bilateral Tumor (i.e. T2a vs. T2b), Identify extracapsular extension (T3a) or Seminal vesicle invasion (T3b)
13 secondary outcomes
Sensitivity of PSMA-1007 PET
Time frame: Through study completion, this is expected to be reviewed within 1 year of imaging
Sensitivity of MRI
Time frame: Through study completion, this is expected to be reviewed within 1 year of imaging
Specificity of PSMA-1007 PET
Time frame: Through study completion, this is expected to be reviewed within 1 year of imaging
Specificity of MRI
Time frame: Through study completion, this is expected to be reviewed within 1 year of imaging
Negative Predictive Value of PSMA-1007 PET
Time frame: Through study completion, this is expected to be reviewed within 1 year of imaging
Negative Predictive Value of MRI
Time frame: Through study completion, this is expected to be reviewed within 1 year of imaging
Positive Predictive Value of PSMA-1007 PET
Time frame: Through study completion, this is expected to be reviewed within 1 year of imaging
Positive Predictive Value of MRI
Time frame: Through study completion, this is expected to be reviewed within 1 year of imaging
Nodal Staging
Time frame: Through study completion, this is expected to be reviewed within 1 year of imaging
Metastatic Staging
Time frame: Through study completion, this is expected to be reviewed within 1 year of imaging
Longest Tumor diameter
Time frame: Through study completion, this is expected to be reviewed within 1 year of imaging
Identification of dominant lesion
Time frame: Through study completion, this is expected to be reviewed within 1 year of imaging
Identification of non-dominant lesion
Time frame: Through study completion, this is expected to be reviewed within 1 year of imaging
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 6 Jun 2024.
- 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.
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 PSMA-1007 Positron Emission Tomography (PET) scan and 3T Magnetic Resonance Imaging (MRI) in people with Prostate Cancer, run by University of Alberta at 1 site in Canada.
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 8 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 6 Jun 2024. 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 Canada. 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?
Tumor T-staging (time frame: Through study completion, this is expected to be reviewed within 1 year of imaging). 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 6 Jun 2024.