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RecruitingNCT05520255Updated Sep 24, 2026

18F-PSMA-1007 PET/CT in Prostate Cancer - Access Trial 2022 to 2028

A Phase 3 interventional study of 18F-PSMA-1007 in Prostate Cancer, sponsored by University of Alberta. Recruiting at 1 site in Canada. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.

Sponsored by University of Alberta · Phase 3, Interventional, and Diagnostic

From the registry’s dates

  • Started Jul 2023; still recruiting 3 years 3 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
2,800
Allocation
Not applicable
Ages
18 Years and older
Sex
Male
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 11 studies in Prostatic Neoplasms by University of Alberta — 5 open to participants now, 6 under way, 2 of them phase 3. Prostatic Neoplasms · University of Alberta.

Planned enrollment
Largest of 10
2,800 · median 144
Started
2023
the only one that year
Phase 3
2 of 11
2 open now
Registered
6th of 11
by date

Among the 11 studies in Prostatic Neoplasms by University of Alberta, this one has the largest planned enrollment of the 10 interventional ones that give a count, is the only one that started in 2023, is one of 2 in phase 3, and was the 6th registered.

Prostatic Neoplasms

7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.

Browse Prostatic Neoplasms studies →

Open to participants now

5 of the 11 studies in Prostatic Neoplasms by University of Alberta are open now, in 5 countries. Recruiting first, the newest first:

By country, each count listing its studies:

Canada5
France1
Norway1
Spain1
United States1

All 5 open studies →

Who these studies take

Of the 1,228 Prostatic Neoplasms studies recruiting now, 928 (76%) set no upper age limit and 76 (6%) stop at 75 or younger; 67 take children under 18; 82 take healthy volunteers.

This study: 18 Years and older · male · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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02

Study 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. 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
  3. 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
  4. 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:

  1. The participant will be screened for adverse effects immediately post-injection
  2. The participant will be screened for adverse effects immediately after the scan (approximately 2.5 hours after tracer injection)
  3. 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:

  1. All lesions categorized as non-specific bone lesions (PSMA-1007 SUVmax > 2.5 but no corresponding lesion on CT) will be recorded
  2. The SUVmax and anatomic location will be recorded for each lesion (max 5 per participant)
  3. 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)
  4. Equivocal lesions will be considered unevaluable and will be excluded from assessment of accuracy
03

Conditions studied

  • Prostate Cancer

Browse trials for

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. 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
  2. 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
  3. Adult participants with a history of -proven prostate cancer and high-risk features for 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
  4. 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)

Exclusion criteria

Exclusion Criteria:

  1. Unable to obtain consent
  2. Weight > 225 kg (weight limit of PET/CT scanners)
  3. Unable to lie flat for 30 minutes to complete the PET/CT imaging session
  4. Lack of intravenous access
  5. History of allergic reaction to 18F-PSMA-1007
  6. Residence outside the Province of Alberta, Northwest Territory, or Yukon Territory (Canada)
  7. Less than 18 years old

NOTE: Androgen deprivation therapy (ADT) is NOT a to participation

Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 3
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
2,800 participants (estimated)

Study arms

  • Experimental
    18F-PSMA-1007

    18F-PSMA-1007, 4 MBq/kg (max 400 MBq; +/- 15%), intravenous, single dose

    Drug: 18F-PSMA-1007

Interventions

06

What researchers measure

Primary outcomes

  1. Safety - immediate

    The participant will be screened for adverse effects immediately post-injection

    Time frame: Immediately after tracer injection

  2. Safety - post scan

    The participant will be screened for adverse effects immediately after the scan (approx 2.5 hours after injection).

    Time frame: 2.5 hours after tracer injection

  3. 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)

    Time frame: 1-7 days after tracer injection

  4. 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

    Time frame: 1 year after tracer injection

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2023 (actual). Primary completion is estimated for Dec 2028, 65 months after the start.

Of 139 non-industry phase 3 interventional studies under Prostatic Neoplasms, half reached primary completion within 99 months of starting (the median), counting those still running; a quarter within 57 and three quarters within 144. This study's planned 65 months is below that.

Counting every sponsor, half of 265 studies reached it within 57 months; a quarter within 31 and three quarters within 100.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 25, 2022
First posted
Aug 29, 2022
StartActual
Jul 25, 2023
Primary completionEst.
Dec 2028
CompletionEst.
Dec 2029
Last update
Sep 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05520255
Lead sponsor
University of Alberta
Responsible party
Sponsor
First posted
Aug 29, 2022
Start date
Jul 25, 2023
Primary completion
Dec 2028 (estimated)
Completion
Dec 2029 (estimated)
Last update
Sep 24, 2026

Study contacts

Jonathan T Abele, MD
Contact
jabele@ualberta.ca
780-407-6907

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Discussion

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