Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
128 participants
OBSERVATIONAL
2023-07-11
2024-11-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Prostate specific membrane antigen (PSMA) is seen on many patients' prostate cancer tumours, and that PSMA expression can not only help detect cancer earlier, but it can also help determine how to treat patients with both standard treatments (e.g., surgery or radiation), as well as systemic new medical treatments (e.g. \[177Lu\]-PSMA-617). The new imaging technology, PSMA PET/CT, has been shown to be more sensitive and specific for the detection of metastatic prostate cancer than the current standard of care imaging (CT and bone scan) and is starting to make its way into clinical use worldwide, but is not yet available outside of clinical trials in Canada.
In recent years, prostate-specific membrane antigen (PSMA, glutamate carboxypeptidase II) has gained a resurgence of interest as a powerful imaging biomarker in prostate cancer. PSMA has been labelled with several single positron emission computed tomography (SPECT) and PET radiotracers to radiographically detect and stage the extent of disease in prostate cancer. This registry study will provide Alberta centres access to a new PET tracer, \[18F\]-PSMA-1007. A prospective registry study of PSMA PET/CT to guide therapy will allow enhanced access to PSMA-PET/CT and examine its effectiveness in characterizing patterns of extent, staging recurrence, and/or metastasis of high-risk prostate cancer, and to personalize therapies in men with prostate cancer. The aim is to determine the proportion of PSMA-PET/CT imaging with positive findings at local, regional, or distant sites.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Experimental: [18F]PSMA-1007 Injection
A single intravenous dose of 3 - 4 MBq/kg (up to a maximum of 400 MBq) of \[18F\]PSMA-1007 Injection will be administered followed by PET/CT imaging.
[18F]-PSMA-1007
\[18F\]PSMA-1007 is a diagnostic radiopharmaceutical for Positron Emission Tomography (PET) scan. The intervention involves single intravenous administration of \[18F\]PSMA-1007 for PET scan.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
[18F]-PSMA-1007
\[18F\]PSMA-1007 is a diagnostic radiopharmaceutical for Positron Emission Tomography (PET) scan. The intervention involves single intravenous administration of \[18F\]PSMA-1007 for PET scan.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Age greater than or equal to 18 years.
3. Subjects with histological diagnosis of prostate cancer.
4. Subjects with Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
5. Subjects with biochemical recurrence or persistence of prostate cancer following initial curative treatment by radical prostatectomy, with two consecutive PSA values \>0.2 ng/ml measured more than 6 weeks after radical prostatectomy. If subjects received subsequent systemic therapy, the most recent PSA measurement prior to PET/CT imaging must be greater than 0.2 ng/mL OR
6. Subjects with biochemical recurrence or persistence of prostate cancer following initial curative treatment by radical prostatectomy and subsequently treated by salvage radiotherapy or pelvic node dissection, with two consecutive PSA values \>0.2 ng/ml. If subjects received subsequent systemic therapy, the most recent PSA measurement prior to PET/CT imaging must be greater than 0.2 ng/mL OR
7. Subjects with biochemical recurrence of prostate cancer after initial curative therapy with radiation therapy (including brachytherapy), or non-standard local ablative therapy (such as high frequency ultrasound, cryoablation, focal laser ablation, etc.), with a PSA level \>2 ng/mL above the nadir after radiation therapy OR
8. Subjects with advanced castration sensitive or castration resistant prostate cancer being considered for localized treatment (surgery, brachytherapy, radiotherapy) of recurrent or oligometastatic prostate cancer. Castration resistance is defined as a PSA level \> 1.0 ng/mL, with 2 consecutive rises above the nadir, in the presence of castrate levels of testosterone (\< 1.7 nmol/L) OR
9. Subjects with metastatic or castration resistant prostate cancer being evaluated for systemic therapy administered in therapeutic clinical trials. The PSA level must be \> 1.0 ng/mL, with 2 consecutive rises above the nadir, in the presence of castrate levels of testosterone (\< 1.7 nmol/L) OR
10. Subjects with high-risk prostate cancer, defined as T3a, Gleason ≥8, or PSA ≥20, and "very high risk" as T3b or T4 disease.
11. Patients of childbearing potential must adhere to the contraception requirement from screening throughout the study period up to 90 days after the last dose of study intervention.
Exclusion Criteria
2. Unable to provide written consent.
3. Exceeds safe weight limit of the PET/CT bed (204.5 kg) or unable to fit through the PET/CT bore (diameter 70 cm).
4. Lack of IV access.
5. History of allergic reaction to \[18F\]-PSMA-1007.
18 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AHS Cancer Control Alberta
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Steven Yip, MD
Role: PRINCIPAL_INVESTIGATOR
Alberta Health services
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Tom Baker Cancer Centre/Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta, Canada
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PSMA-PET-1007
Identifier Type: -
Identifier Source: org_study_id