Prostate CancerPhase 3NCT05520255
18F-PSMA-1007 PET/CT in Prostate Cancer - Access Trial 2022 to 2028
A Phase 3 study testing 18F-PSMA-1007 in people with Prostate Cancer, run by University of Alberta at 1 site in Canada.
Trial summary
A two-centre prospective cohort phase III study of 18F-PSMA-1007 PET/CT imaging in specific patient populations: 1. Adults patients (≥18 years old) with a history of radical prostatectomy for treatment of prostate cancer, and a serum prostate specific antigen (PSA) ≥ 0.2 mcg/L 2. 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?
- 18F-PSMA-1007
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,800 participants
- Where
- 1 siteCanada
- Study dates
- 25 Jul 2023to Dec 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Adult participants (≥ 18 years old) with a history of radical prostatectomy for treatment of prostate cancer, and a serum prostate specific antigen (PSA) ≥ 0.2 mcg/L
- Adult participants with a history of radiotherapy, cryotherapy, or brachytherapy for treatment of prostate cancer, and a serum PSA progressively rising to ≥ 2 mcg/L (minimum two samples) OR a serum PSA doubling time of < 9 months
- Adult participants with a history of biopsy-proven prostate cancer and high-risk features for metastatic disease prior to treatment with radical prostatectomy, radiotherapy, cryotherapy, brachytherapy, or other similar therapy. High-risk features include a Gleason score ≥ 7, serum PSA ≥ 20 mcg/L, OR minimum clinical T-stage T2c
- Adult patients who do not meet criteria 1-3 but in whom a 18F-PSMA-1007 PET/CT scan is expected to provide clinical benefit as determined by a Urologist, Radiation Oncologist, Medical Oncologist, or Nuclear Medicine physician (licensed in Alberta)
Who cannot join
- Unable to obtain consent
- Weight > 225 kg (weight limit of PET/CT scanners)
- Unable to lie flat for 30 minutes to complete the PET/CT imaging session
- Lack of intravenous access
- History of allergic reaction to 18F-PSMA-1007
- Residence outside the Province of Alberta, Northwest Territory, or Yukon Territory (Canada)
- Less than 18 years old
- NOTE: Androgen deprivation therapy (ADT) is NOT a contraindication to participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University of Alberta
Edmonton, Alberta, T6G 2R3
Jonathan Abele, MD, 780-407-6907, jabele@ualberta.ca
About this study
A two-centre prospective cohort phase III study of 18F-PSMA-1007 PET/CT imaging in specific patient populations:
- Adults patients (≥18 years old) with a history of radical prostatectomy for treatment of prostate cancer, and a serum prostate specific antigen (PSA) ≥ 0.2 mcg/L
- Adult patients with a history of radiotherapy, cryotherapy, or brachytherapy for treatment of prostate cancer, and a serum PSA progressively rising to ≥ 2 mcg/L (minimum two samples) OR a serum PSA doubling time of < 9 months
- Adult patients with a history of biopsy-proven prostate cancer and high-risk features for metastatic disease prior to treatment with radical prostatectomy, radiotherapy, cryotherapy, or brachytherapy. High-risk features include a Gleason score ≥ 7, serum PSA ≥ 20 mcg/L, OR minimum clinical T-stage T2c
- Adult patients who do not meet criteria 1-3 but in whom a 18F-PDAM-1007 PET/CT scan is expected to provide clinical benefit as determined by a Urologist, Radiation Oncologist, Medical Oncologist, or Nuclear Medicine physician (licensed in Alberta)
Read more
The safety of the investigational 18F-PSMA-1007 tracer will be evaluated in 3 ways:
- The participant will be screened for adverse effects immediately post-injection
- The participant will be screened for adverse effects immediately after the scan (approximately 2.5 hours after tracer injection)
- The participant will be provided an information sheet and contact information for self-reporting of any delayed adverse events (1-7 days post injection)
The incidence of and activity of non-specific bone lesions will be quantified and evaluated as follows:
- All lesions categorized as non-specific bone lesions (PSMA-1007 SUVmax > 2.5 but no corresponding lesion on CT) will be recorded
- The SUVmax and anatomic location will be recorded for each lesion (max 5 per participant)
- Recorded lesions will be evaluated a minimum of 1 year post-scan to determine whether they are benign or malignant based on previously published reference standard criteria (Arnfield et al., 2021)
- Equivocal lesions will be considered unevaluable and will be excluded from assessment of accuracy
- Conditions
- Prostate Cancer
- Being tested
- 18F-PSMA-1007
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-PSMA-1007Drug
18F-PSMA-1007 intravenous injection
| Study group | Role | What they receive |
|---|---|---|
| 18F-PSMA-1007 | Experimental | 18F-PSMA-1007, 4 MBq/kg (max 400 MBq; +/- 15%), intravenous, single dose Receives: Drug: 18F-PSMA-1007 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - immediate
The participant will be screened for adverse effects immediately post-injection
Measured: Immediately after tracer injection
Safety - post scan
The participant will be screened for adverse effects immediately after the scan (approx 2.5 hours after injection).
Measured: 2.5 hours after tracer injection
Safety - delayed
The participant will be provided information to contact the study team to self-report and delayed adverse events (1-7 days post-injection)
Measured: 1-7 days after tracer injection
Non-specific bone lesion assessment (NSBLs)
SUVmax and anatomic location of NSBLs (max 5 per participant) will be compared to a reference standard 1 year after tracer injection
Measured: 1 year after tracer injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2022
- Study start25 Jul 2023
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (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.
- 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 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Two-centre prospective cohort phase III study
- Masking
- None (open label)
- Enrolment
- 2,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05520255
- Sponsor's protocol ID
- CC-22-0204
- Status last verified
- Sep 2026
- First submitted
- 25 Aug 2022
- Last updated
- 24 Sep 2026
- 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 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 18F-PSMA-1007 PET/CT in Prostate Cancer - Access Trial 2022 to 2028
- ClinicalTrials.gov ID
- NCT05520255
- Acronym / sponsor ID
- CC-22-0204
- Conditions
- Prostate Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,800 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 25 Jul 2023 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 29 Aug 2022 (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 two-centre prospective cohort phase III study of 18F-PSMA-1007 PET/CT imaging in specific patient populations:
- Adults patients (≥18 years old) with a history of radical prostatectomy for treatment of prostate cancer, and a serum prostate specific antigen (PSA) ≥ 0.2 mcg/L
- Adult patients with a history of radiotherapy, cryotherapy, or brachytherapy for treatment of prostate cancer, and a serum PSA progressively rising to ≥ 2 mcg/L (minimum two samples) OR a serum PSA doubling time of < 9 months
- Adult patients with a history of biopsy-proven prostate cancer and high-risk features for metastatic disease prior to treatment with radical prostatectomy, radiotherapy, cryotherapy, or brachytherapy. High-risk features include a Gleason score ≥ 7, serum PSA ≥ 20 mcg/L, OR minimum clinical T-stage T2c
- Adult patients who do not meet criteria 1-3 but in whom a 18F-PDAM-1007 PET/CT scan is expected to provide clinical benefit as determined by a Urologist, Radiation Oncologist, Medical Oncologist, or Nuclear Medicine physician (licensed in Alberta)
The safety of the investigational 18F-PSMA-1007 tracer will be evaluated in 3 ways:
- The participant will be screened for adverse effects immediately post-injection
- The participant will be screened for adverse effects immediately after the scan (approximately 2.5 hours after tracer injection)
- The participant will be provided an information sheet and contact information for self-reporting of any delayed adverse events (1-7 days post injection)
The incidence of and activity of non-specific bone lesions will be quantified and evaluated as follows:
- All lesions categorized as non-specific bone lesions (PSMA-1007 SUVmax > 2.5 but no corresponding lesion on CT) will be recorded
- The SUVmax and anatomic location will be recorded for each lesion (max 5 per participant)
- Recorded lesions will be evaluated a minimum of 1 year post-scan to determine whether they are benign or malignant based on previously published reference standard criteria (Arnfield et al., 2021)
- Equivocal lesions will be considered unevaluable and will be excluded from assessment of accuracy
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Two-centre prospective cohort phase III study
| Arm | Type | Receives |
|---|---|---|
| 18F-PSMA-1007 | Experimental | Drug: 18F-PSMA-100718F-PSMA-1007, 4 MBq/kg (max 400 MBq; +/- 15%), intravenous, single dose |
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)
- Adult participants (≥ 18 years old) with a history of radical prostatectomy for treatment of prostate cancer, and a serum prostate specific antigen (PSA) ≥ 0.2 mcg/L
- Adult participants with a history of radiotherapy, cryotherapy, or brachytherapy for treatment of prostate cancer, and a serum PSA progressively rising to ≥ 2 mcg/L (minimum two samples) OR a serum PSA doubling time of < 9 months
- Adult participants with a history of biopsy-proven prostate cancer and high-risk features for metastatic disease prior to treatment with radical prostatectomy, radiotherapy, cryotherapy, brachytherapy, or other similar therapy. High-risk features include a Gleason score ≥ 7, serum PSA ≥ 20 mcg/L, OR minimum clinical T-stage T2c
- Adult patients who do not meet criteria 1-3 but in whom a 18F-PSMA-1007 PET/CT scan is expected to provide clinical benefit as determined by a Urologist, Radiation Oncologist, Medical Oncologist, or Nuclear Medicine physician (licensed in Alberta)
Key exclusion criteria (8 listed)
- Unable to obtain consent
- Weight > 225 kg (weight limit of PET/CT scanners)
- Unable to lie flat for 30 minutes to complete the PET/CT imaging session
- Lack of intravenous access
- History of allergic reaction to 18F-PSMA-1007
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-PSMA-100718F-PSMA-1007 intravenous injection | Drug | 18F-PSMA-1007 |
Primary outcome
Safety - immediate
Time frame: Immediately after tracer injection
The participant will be screened for adverse effects immediately post-injection
Safety - post scan
Time frame: 2.5 hours after tracer injection
The participant will be screened for adverse effects immediately after the scan (approx 2.5 hours after injection).
Safety - delayed
Time frame: 1-7 days after tracer injection
The participant will be provided information to contact the study team to self-report and delayed adverse events (1-7 days post-injection)
Non-specific bone lesion assessment (NSBLs)
Time frame: 1 year after tracer injection
SUVmax and anatomic location of NSBLs (max 5 per participant) will be compared to a reference standard 1 year after tracer injection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 18F-PSMA-1007 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 4 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: looking for participants now, as of the sponsor's last update on 24 Sep 2026. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jonathan T Abele, MD (780-407-6907, jabele@ualberta.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety - immediate (time frame: Immediately after tracer injection). The study lists 4 primary outcomes in all. 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 24 Sep 2026.