OncologyPhase 2NCT05712174
A Study of [18]F-PSMA-1007 in Patients With Known or Suspected Metastatic Prostate Cancer
A Phase 2 study testing [18]F-PSMA-1007 in people with Oncology and Prostate Cancer, run by AHS Cancer Control Alberta at 1 site in Canada.
Trial summary
A [18]F-PSMA-1007 PET/CT or PET/MRI scan are nuclear medicine tests used to create pictures of the whole body that may show where cells that express Prostate-Specific Membrane Antigen (PSMA) are found. PSMA is a transmembrane protein that is overexpressed in the majority of prostate cancers. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Oncology, Prostate Cancer
- What is being tested?
- [18]F-PSMA-1007
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteCanada
- Study dates
- 14 Sep 2023to 5 May 2025
- 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
- Confirmed prostate cancer by histopathology or cytology;
- Eastern Cooperative Oncology Group (ECOG) Performance Scale Score ≤ 2 within two weeks of enrollment;
- Males at least 18 years of age;
- Any of the following clinical criteria:
- High risk localized, treatment naive prostate cancer, defined as clinical ≥T3a, Gleason score ≥8 (or grade group 4-5), or PSA >20ng/mL. Clinical T-stage may be defined based on physical exam or standard pelvic imaging (MRI/CT).
- High-tier intermediate risk, defined as at least two of the following: clinical T2c, Gleason score ≥7 (or Grade group 2-3) and PSA 10-20 ng/mL.
Show all 12Show fewer
- Biochemically recurrent prostate cancer defined as persistently elevated or rising PSA after radical prostatectomy, with a PSA value of ≥0.2ng/mL on at least two readings, or PSA with a rise of at least ≥2 ng/mL above the nadir in patients who have received definitive radiation therapy (28).
- Metastatic disease documented on conventional imaging (CT and/or bone scan).
- 99m-Technecium bone scan and CT of the chest abdomen and pelvis, within 4 weeks of study enrollment.
- Receipt of a complete [18]F-PSMA-1007 PET/CT or PET/MRI referral package, including baseline history information and treatment intent from the referring physician, prior to enrolment.
- Able and willing to follow instructions and comply with the protocol;
- Ability to provide written informed consent prior to participation in the study.
Who cannot join
- Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.);
- Inability to complete the investigational imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.);
- Weight exceeding the PET/CT or PET/MRI scanner limit;
- Known allergic reaction to [18]F-PSMA-1007;
- Patients who have initiated new therapy (ADT, systemic therapy, or radiation) for their prostate cancer within 4 weeks of enrollment in those with high-tier intermediate risk or high risk localized prostate cancer, or biochemically recurrent prostate cancer post-prostatectomy or definitive radiotherapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Study of Fluorine-18 (18F)-Labeled PSMA-1007 in Patients With Known or Suspected Metastatic Prostatic Carcinoma
A [18]F-PSMA-1007 PET/CT or PET/MRI scan are nuclear medicine tests used to create pictures of the whole body that may show where cells that express Prostate-Specific Membrane Antigen (PSMA) are found. PSMA is a transmembrane protein that is overexpressed in the majority of prostate cancers. PSMA imaging utilizes this overexpression, by binding on the transmembrane receptor and internalization in the cancer cells. The internalized isotope can then be imaged with the use of a PET/CT or PET/MRI scanner and show where cancer cells may be present in the body. This imaging modality has been shown to be superior to conventional imaging, such as bone scan and CT, in the detection of prostate cancer tumors.
The purpose of this study is to: 1) assess the clinical impact of a [18]F-PSMA-1007 scan on patient management plans; 2) assess the diagnostic effectiveness of a [18]F-PSMA-1007 scan in participants with known or suspected metastatic prostate cancer, as compared to standard of care CT chest, abdomen, pelvis and bone scan; 3) evaluate the safety of [18]F-PSMA-1007; and 4) assess potential correlations of PSMA level of uptake in certain tumors with cancer biologic markers such as PSA and Gleason score.
Read the detailed description
This is a Phase II, diagnostic imaging, controlled, open-label, single site study in four cohorts of patients with known or suspected metastatic prostate cancer. All participants will be imaged with [18]F-PSMA-1007 PET/CT; [18]F-PSMA-1007 PET/MRI may be performed instead of a PET/CT, if PET/MRI is available.
The patients will be assessed for AEs after administration of [18]F-PSMA-1007, during their visit to the Nuclear Medicine Department. The assessment of impact on patient management will be performed using a questionnaire both before and after the [18]F-PSMA-1007 PET/CT or PET/MRI scan. The efficacy evaluation will consist of [18]F-PSMA-1007 PET/CT or PET/MRI clinical accuracy compared to standard of care CT and bone scan. Standard gadolinium-based contrast enhanced PET/MRI imaging may be performed if clinically indicated and if there are no contraindications. If a PET/MRI is performed, the clinical accuracy of the MRI component of the PET/MRI will be compared to the baseline CT. [18]F-PSMA-1007 uptake (SUVmax, Uptake Score) will be assessed in a selection of lesions and compared to PSA values collected on the day of the scan and Gleason score collected from the participant's medical history.
- Conditions
- Oncology, Prostate Cancer
- Being tested
- [18]F-PSMA-1007
- Keywords
- PSMA, [18]F-PSMA-1007, Positron Emission Tomography
- Medical subject headings
- Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18]F-PSMA-1007Drug
[18]F-PSMA-1007 is a diagnostic radiopharmaceutical for use with PET/CT or PET/MRI scanning to diagnose prostate cancer.
| Study group | Role | What they receive |
|---|---|---|
| [18]F-PSMA-1007 PET/CT or PET/MRI | Experimental | All participants will undergo a single [18]F-PSMA-1007 PET/CT or PET/MRI scan. Intravenous bolus injection of 4 MBq/kg +/- 10% of [18]F-PSMA-1007, up to a maximum of 400 MBq. Receives: Drug: [18]F-PSMA-1007 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire based assessment of the impact of [18]F-PSMA-1007 PET/CT or PET/MRI on patient management plans
There is sparsity of evidence regarding the impact of the results of [18]F-PSMA-1007 PET/CT or PET/MRI on patient management. With this analysis we will study whether the treatment plan is modified with the findings of the [18]F-PSMA-1007 PET/CT or PET/MRI, by asking the referring physician to complete a questionnaire on paper or electronically (via REDCap). Questions will include the patient's clinical TNM stage, treatment intent (curative vs palliative), planned treatment modalities, and clinical confidence in their treatment plan, both before and after [18]F-PSMA-1007 imaging.
Measured: Prior to and within 30 days following [18]F-PSMA-1007 PET/CT or PET/MRI
Secondary outcomes (5)
To confirm the diagnostic effectiveness of [18]F-PSMA-1007 PET/CT or PET/MRI in participants with known or suspected metastatic prostate cancer compared to standard of care cross-sectional imaging (CT chest, abdomen, pelvis)
A Nuclear Medicine physician will correlate the [18]F-PSMA-1007 PET/CT or PET/MRI findings with CT findings and comment on whether [18]F-PSMA-1007 avid lesions are visualized on standard of care imaging. The [18]F-PSMA-1007 PET/CT or PET/MRI scan findings will be compared globally to standard of care imaging to document if more or fewer lesions are seen on [18]F-PSMA-1007 PET/CT or PET/MRI than conventional imaging.
A reader confidence score will be used to assess reader certainty in finding characterization. The findings will be considered metastatic for scores 4 and 5.
Measured: Within 7 days post [18]F-PSMA-1007 PET/CT or PET/MRI
To confirm the diagnostic effectiveness of [18]F-PSMA-1007 PET/CT or PET/MRI in participants with known or suspected metastatic prostate cancer compared to standard of care cross-sectional imaging (bone scan)
A Nuclear Medicine physician will correlate the [18]F-PSMA-1007 PET/CT or PET/MRI findings with bone scan findings and comment on whether [18]F-PSMA-1007 avid lesions are visualized on standard of care imaging. The [18]F-PSMA-1007 PET/CT or PET/MRI scan findings will be compared globally to standard of care imaging to document if more or fewer lesions are seen on [18]F-PSMA-1007 PET/CT or PET/MRI than conventional imaging.
A reader confidence score will be used to assess reader certainty in finding characterization. The findings will be considered metastatic for scores 4 and 5.
Measured: Within 7 days post [18]F-PSMA-1007 PET/CT or PET/MRI
The [18]F-PSMA-1007 level of avidity will be assessed in selected lesions and compared to background activity and cancer biologic markers (PSA value)
We will explore whether there is a correlation between [18]F-PSMA-1007 uptake and PSA values. The intensity of tumor uptake of [18]F-PSMA-1007 will be assessed by an experienced Nuclear Medicine physician using visual interpretation and computer-assisted techniques in up to five (5) lesions. The maximum Standardized Uptake Value (SUVmax) will be determined for the tumor site(s), the liver, blood pool and parotid using the standard algorithm available on the PET scanners.
Measured: Within 7 days post [18]F-PSMA-1007 PET/CT or PET/MRI
The [18]F-PSMA-1007 level of avidity will be assessed in selected lesions and compared to background activity and cancer biologic markers (Gleason score)
We will explore whether there is a correlation between [18]F-PSMA-1007 uptake and Gleason score. The intensity of tumor uptake of [18]F-PSMA-1007 will be assessed by an experienced Nuclear Medicine physician using visual interpretation and computer-assisted techniques in up to five (5) lesions. The maximum Standardized Uptake Value (SUVmax) will be determined for the tumor site(s), the liver, blood pool and parotid using the standard algorithm available on the PET scanners.
Measured: Within 7 days post [18]F-PSMA-1007 PET/CT or PET/MRI
To evaluate the safety of [18]F-PSMA-1007 PET/CT or PET/MRI imaging
Adverse events (AEs) following [18]F-PSMA-1007 administration will be assessed and graded using CTCAE v.5.
Measured: Up to 24 hours after [18]F-PSMA-1007 administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2023
- Study start14 Sep 2023
- Primary completion5 May 2025
- Study completion5 May 2025
Why it stopped: Accrual to the biochemically recurrent and metastatic cohorts complete; however, accrual to the remaining two cohorts was lagging and deemed no longer feasible.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OncologyStudies 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
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- AHS Cancer Control Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stella Koumna, MD, Principal investigator, Cross Cancer Institute, Alberta Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05712174
- Sponsor's protocol ID
- IIT-0030
- Status last verified
- Jun 2025
- First submitted
- 17 Jan 2023
- Last updated
- 12 Jun 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 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Fluorine-18 (18F)-Labeled PSMA-1007 in Patients With Known or Suspected Metastatic Prostatic Carcinoma
- ClinicalTrials.gov ID
- NCT05712174
- Acronym / sponsor ID
- IIT-0030
- Conditions
- Oncology, Prostate Cancer
- Keywords
- PSMA, [18]F-PSMA-1007, Positron Emission Tomography
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Accrual to the biochemically recurrent and metastatic cohorts complete; however, accrual to the remaining two cohorts was lagging and deemed no longer feasible.
- Enrolment
- 176 participants (actual)
- Lead sponsor
- AHS Cancer Control AlbertaUniversity, hospital or other
- Study start
- 14 Sep 2023 (actual)
- Primary completion
- 5 May 2025 (actual)
- Study completion
- 5 May 2025 (actual)
- First posted
- 3 Feb 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.
A [18]F-PSMA-1007 PET/CT or PET/MRI scan are nuclear medicine tests used to create pictures of the whole body that may show where cells that express Prostate-Specific Membrane Antigen (PSMA) are found. PSMA is a transmembrane protein that is overexpressed in the majority of prostate cancers. PSMA imaging utilizes this overexpression, by binding on the transmembrane receptor and internalization in the cancer cells. The internalized isotope can then be imaged with the use of a PET/CT or PET/MRI scanner and show where cancer cells may be present in the body. This imaging modality has been shown to be superior to conventional imaging, such as bone scan and CT, in the detection of prostate cancer tumors.
The purpose of this study is to: 1) assess the clinical impact of a [18]F-PSMA-1007 scan on patient management plans; 2) assess the diagnostic effectiveness of a [18]F-PSMA-1007 scan in participants with known or suspected metastatic prostate cancer, as compared to standard of care CT chest, abdomen, pelvis and bone scan; 3) evaluate the safety of [18]F-PSMA-1007; and 4) assess potential correlations of PSMA level of uptake in certain tumors with cancer biologic markers such as PSA and Gleason score.
Detailed description
This is a Phase II, diagnostic imaging, controlled, open-label, single site study in four cohorts of patients with known or suspected metastatic prostate cancer. All participants will be imaged with [18]F-PSMA-1007 PET/CT; [18]F-PSMA-1007 PET/MRI may be performed instead of a PET/CT, if PET/MRI is available.
The patients will be assessed for AEs after administration of [18]F-PSMA-1007, during their visit to the Nuclear Medicine Department. The assessment of impact on patient management will be performed using a questionnaire both before and after the [18]F-PSMA-1007 PET/CT or PET/MRI scan. The efficacy evaluation will consist of [18]F-PSMA-1007 PET/CT or PET/MRI clinical accuracy compared to standard of care CT and bone scan. Standard gadolinium-based contrast enhanced PET/MRI imaging may be performed if clinically indicated and if there are no contraindications. If a PET/MRI is performed, the clinical accuracy of the MRI component of the PET/MRI will be compared to the baseline CT. [18]F-PSMA-1007 uptake (SUVmax, Uptake Score) will be assessed in a selection of lesions and compared to PSA values collected on the day of the scan and Gleason score collected from the participant's medical history.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [18]F-PSMA-1007 PET/CT or PET/MRI | Experimental | Drug: [18]F-PSMA-1007All participants will undergo a single [18]F-PSMA-1007 PET/CT or PET/MRI scan. Intravenous bolus injection of 4 MBq/kg +/- 10% of [18]F-PSMA-1007, up to a maximum of 400 MBq. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Confirmed prostate cancer by histopathology or cytology;
- Eastern Cooperative Oncology Group (ECOG) Performance Scale Score ≤ 2 within two weeks of enrollment;
- Males at least 18 years of age;
- Any of the following clinical criteria:
- 99m-Technecium bone scan and CT of the chest abdomen and pelvis, within 4 weeks of study enrollment.
Key exclusion criteria (5 listed)
- Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.);
- Inability to complete the investigational imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.);
- Weight exceeding the PET/CT or PET/MRI scanner limit;
- Known allergic reaction to [18]F-PSMA-1007;
- Patients who have initiated new therapy (ADT, systemic therapy, or radiation) for their prostate cancer within 4 weeks of enrollment in those with high-tier intermediate risk or high risk localized prostate cancer, or biochemically recurrent prostate cancer post-prostatectomy or definitive radiotherapy.
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 |
|---|---|---|
| [18]F-PSMA-1007[18]F-PSMA-1007 is a diagnostic radiopharmaceutical for use with PET/CT or PET/MRI scanning to diagnose prostate cancer. | Drug | [18]F-PSMA-1007 PET/CT or PET/MRI |
Primary outcome
Questionnaire based assessment of the impact of [18]F-PSMA-1007 PET/CT or PET/MRI on patient management plans
Time frame: Prior to and within 30 days following [18]F-PSMA-1007 PET/CT or PET/MRI
There is sparsity of evidence regarding the impact of the results of [18]F-PSMA-1007 PET/CT or PET/MRI on patient management. With this analysis we will study whether the treatment plan is modified with the findings of the [18]F-PSMA-1007 PET/CT or PET/MRI, by asking the referring physician to complete a questionnaire on paper or electronically (via REDCap). Questions will include the patient's clinical TNM stage, treatment intent (curative vs palliative), planned treatment modalities, and clinical confidence in their treatment plan, both before and after [18]F-PSMA-1007 imaging.
5 secondary outcomes
To confirm the diagnostic effectiveness of [18]F-PSMA-1007 PET/CT or PET/MRI in participants with known or suspected metastatic prostate cancer compared to standard of care cross-sectional imaging (CT chest, abdomen, pelvis)
Time frame: Within 7 days post [18]F-PSMA-1007 PET/CT or PET/MRI
To confirm the diagnostic effectiveness of [18]F-PSMA-1007 PET/CT or PET/MRI in participants with known or suspected metastatic prostate cancer compared to standard of care cross-sectional imaging (bone scan)
Time frame: Within 7 days post [18]F-PSMA-1007 PET/CT or PET/MRI
The [18]F-PSMA-1007 level of avidity will be assessed in selected lesions and compared to background activity and cancer biologic markers (PSA value)
Time frame: Within 7 days post [18]F-PSMA-1007 PET/CT or PET/MRI
The [18]F-PSMA-1007 level of avidity will be assessed in selected lesions and compared to background activity and cancer biologic markers (Gleason score)
Time frame: Within 7 days post [18]F-PSMA-1007 PET/CT or PET/MRI
To evaluate the safety of [18]F-PSMA-1007 PET/CT or PET/MRI imaging
Time frame: Up to 24 hours after [18]F-PSMA-1007 administration
Results and safety
The study was stopped early (reason given: Accrual to the biochemically recurrent and metastatic cohorts complete; however, accrual to the remaining two cohorts was lagging and deemed no longer feasible.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 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.
Stella Koumna, MD principal investigator
Cross Cancer Institute, Alberta Health Services
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 [18]F-PSMA-1007 in people with Oncology and Prostate Cancer, run by AHS Cancer Control 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 12 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: stopped early, as of the sponsor's last update on 12 Jun 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 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 was stopped early (reason given: Accrual to the biochemically recurrent and metastatic cohorts complete; however, accrual to the remaining two cohorts was lagging and deemed no longer feasible.). Results are not available in the source record.
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?
Questionnaire based assessment of the impact of [18]F-PSMA-1007 PET/CT or PET/MRI on patient management plans (time frame: Prior to and within 30 days following [18]F-PSMA-1007 PET/CT or PET/MRI). 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 12 Jun 2025.