Prostate CancerPhase 3NCT04684628
68Ga-PSMA PET/CT in Prostate Cancer
A Phase 3 study testing 68Ga-PSMA PET/CT in people with Prostate Cancer, run by University of Saskatchewan at 1 site in Canada.
Trial summary
This is a single-center, multi-arm, open-label, phase III trial in up to 500 patients with biopsy-proven prostate cancer. Participants will receive regular standard of clinical care. Read more about this study
- Who is it for?
- Ages 18 to 100 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- 68Ga-PSMA PET/CT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteCanada
- Study dates
- 9 Dec 2020to Dec 2025
- Phase
- Phase 3
- 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 to 100 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male sex
- Age 18 years or older
- Previously diagnosed with prostate cancer, under referring physician's care
- ECOG performance status 0 - 3, inclusive
- Able to understand and provide written informed consent
- Able to tolerate the physical/logistical requirements of a PET/CT scan including lying supine (or prone) for up to 40 minutes and tolerating intravenous cannulation for injection
Who cannot join
- Patients who are medically unstable (e.g. acute cardiac or respiratory distress or hypotensive)
- Patients who exceed the safe weight limit of the PET/CT bed (usually approximately 400 lbs.) or who cannot fit through the PET/CT bore (usually approximately 70 cm diameter)
- Patients with unmanageable claustrophobia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Sensitivity and Specificity of 68Ga-HBED-CC-PSMA PET/CT in Prostate Cancer
This is a single-center, multi-arm, open-label, phase III trial in up to 500 patients with biopsy-proven prostate cancer.
Participants will receive regular standard of clinical care. The only study-specific procedures will the administration of 68Ga-PSMA-11 followed by a PET/CT (positron emission tomography/computed tomography) scan. Participants will be followed for two hours after the infusion for identification of any immediate adverse events (AE), and will be contacted by telephone after 7 to 14 days to enquire about any delayed AEs.
PET/CT images, CT-alone images and bone scans will be read by separate readers who will not be blinded to all other clinical and imaging information. The standard of truth will be a consensus of the readers based on all available clinical, imaging, and histopathological information available for up to 6 months after the PET/CT scan.
- Conditions
- Prostate Cancer
- Being tested
- 68Ga-PSMA PET/CT
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-PSMA PET/CTDrug
Administration of 68Ga-PSMA-11 followed by a PET/CT scan at 45 min after injection.
| Study group | Role | What they receive |
|---|---|---|
| Biochemical Reoccurrence | Experimental | Patients with biochemical reoccurrence (post-prostatectomy or post radical radiotherapy) or patients with biochemical relapse with rising PSA in spite of taking hormone treatment (this situation is characterized as non-metastatic castration resistant prostate cancer M0CRPC) and compare it to bone scan and CT in 2 groups:
PSA >= 0.2 ng/mL and <= 0.5 ng/mL or PSA > 0.5 ng/ml Receives: Drug: 68Ga-PSMA PET/CT |
| High Risk Prostate Cancer | Experimental | Patients with high risk prostate cancer who have not received any definitive treatment. These high-risk patients are defined using the D'Amico Classification System: Those with a PSA of more than 20, or a Gleason score equal to or greater than 8, or have a clinical stage greater than T2c. Receives: Drug: 68Ga-PSMA PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of 68Ga-PSMA-11 PET/CT compared to that of CT alone and bone scan in two different cohorts of prostrate cancer patients.
PET/CT images, CT-alone images and bone scans will be read by separate readers who will not be blinded to all other clinical and imaging information. A target lesion list will be created, finalized and entered into the research study file. Reviewer will assign each patient an overall likelihood of prostate cancer score, equal to the highest score of any target lesion on the PET/CT scan. Following the entry of final PET/CT, CT-only and bone scan target lesion lists and overall likelihood scores into the study file, all the experienced readers will become un-blinded and adjudicate by consensus in conjunction with referring physicians all lesions identified by each on their respective datasets and will assign a final consensus to each lesion. Each target lesion identified by each reader will be followed clinically, radiologically and histopathologically over a minimum period of 6 months and the final consensus can be modified based on this follow-up.
Measured: 6 months
Secondary outcomes (1)
The secondary endpoint is the number of adverse events, both immediate and delayed.
Immediate and delayed adverse events will be captured for every patient and will be analysed at the end of study.
Measured: baseline (i.e. Imaging visit) and at the end of study visit (day 7 to day 14)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study start9 Dec 2020
- Primary completionJan 2025 (estimated)
- Study completionDec 2025 (estimated)
Why it stopped: Study is suspended due to some logistic issues
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.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- There will be two groups depending upon the disease status. Cohort 1- Participant will be in Cohort 1 if have biochemical reoccurrence (post-prostatectomy or post radical radiotherapy) or have biochemical relapse with rising PSA in spite of taking hormone treatment (this situation is characterized as non-metastatic castration resistant prostate cancer M0CRPC). Cohort 2- Participant will be in Cohort 2 if have high risk prostate cancer and have not received any definitive treatment. Participants of both cohorts will receive the same study drug for imaging procedure. Participants of both the cohort will undergo one PET/CT scan at 45 minute after a single dose injection of 68Ga-PSMA-11.
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rajan Rakheja, University of Saskatchewan
- Investigators
- Rajan Rakheja, Principal investigator, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04684628
- Sponsor's protocol ID
- PSMA-01
- Status last verified
- Apr 2024
- First submitted
- 14 Dec 2020
- Last updated
- 2 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Sensitivity and Specificity of 68Ga-HBED-CC-PSMA PET/CT in Prostate Cancer
- ClinicalTrials.gov ID
- NCT04684628
- Acronym / sponsor ID
- PSMA-01
- Conditions
- Prostate Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Study is suspended due to some logistic issues
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Study start
- 9 Dec 2020 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 24 Dec 2020 (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 is a single-center, multi-arm, open-label, phase III trial in up to 500 patients with biopsy-proven prostate cancer.
Participants will receive regular standard of clinical care. The only study-specific procedures will the administration of 68Ga-PSMA-11 followed by a PET/CT (positron emission tomography/computed tomography) scan. Participants will be followed for two hours after the infusion for identification of any immediate adverse events (AE), and will be contacted by telephone after 7 to 14 days to enquire about any delayed AEs.
PET/CT images, CT-alone images and bone scans will be read by separate readers who will not be blinded to all other clinical and imaging information. The standard of truth will be a consensus of the readers based on all available clinical, imaging, and histopathological information available for up to 6 months after the PET/CT scan.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- There will be two groups depending upon the disease status. Cohort 1- Participant will be in Cohort 1 if have biochemical reoccurrence (post-prostatectomy or post radical radiotherapy) or have biochemical relapse with rising PSA in spite of taking hormone treatment (this situation is characterized as non-metastatic castration resistant prostate cancer M0CRPC). Cohort 2- Participant will be in Cohort 2 if have high risk prostate cancer and have not received any definitive treatment. Participants of both cohorts will receive the same study drug for imaging procedure. Participants of both the cohort will undergo one PET/CT scan at 45 minute after a single dose injection of 68Ga-PSMA-11.
| Arm | Type | Receives |
|---|---|---|
| Biochemical Reoccurrence | Experimental | Drug: 68Ga-PSMA PET/CTPatients with biochemical reoccurrence (post-prostatectomy or post radical radiotherapy) or patients with biochemical relapse with rising PSA in spite of taking hormone treatment (this situation is characterized as non-metastatic castration resistant prostate cancer M0CRPC) and compare it to bone scan and CT in 2 groups: PSA >= 0.2 ng/mL and <= 0.5 ng/mL or PSA > 0.5 ng/ml |
| High Risk Prostate Cancer | Experimental | Drug: 68Ga-PSMA PET/CTPatients with high risk prostate cancer who have not received any definitive treatment. These high-risk patients are defined using the D'Amico Classification System: Those with a PSA of more than 20, or a Gleason score equal to or greater than 8, or have a clinical stage greater than T2c. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male sex
- Age 18 years or older
- Previously diagnosed with prostate cancer, under referring physician's care
- ECOG performance status 0 - 3, inclusive
- Able to understand and provide written informed consent
Key exclusion criteria (3 listed)
- Patients who are medically unstable (e.g. acute cardiac or respiratory distress or hypotensive)
- Patients who exceed the safe weight limit of the PET/CT bed (usually approximately 400 lbs.) or who cannot fit through the PET/CT bore (usually approximately 70 cm diameter)
- Patients with unmanageable claustrophobia
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 |
|---|---|---|
| 68Ga-PSMA PET/CTAdministration of 68Ga-PSMA-11 followed by a PET/CT scan at 45 min after injection. | Drug | Biochemical Reoccurrence, High Risk Prostate Cancer |
Primary outcome
Sensitivity and specificity of 68Ga-PSMA-11 PET/CT compared to that of CT alone and bone scan in two different cohorts of prostrate cancer patients.
Time frame: 6 months
PET/CT images, CT-alone images and bone scans will be read by separate readers who will not be blinded to all other clinical and imaging information. A target lesion list will be created, finalized and entered into the research study file. Reviewer will assign each patient an overall likelihood of prostate cancer score, equal to the highest score of any target lesion on the PET/CT scan. Following the entry of final PET/CT, CT-only and bone scan target lesion lists and overall likelihood scores into the study file, all the experienced readers will become un-blinded and adjudicate by consensus in conjunction with referring physicians all lesions identified by each on their respective datasets and will assign a final consensus to each lesion. Each target lesion identified by each reader will be followed clinically, radiologically and histopathologically over a minimum period of 6 months and the final consensus can be modified based on this follow-up.
1 secondary outcome
The secondary endpoint is the number of adverse events, both immediate and delayed.
Time frame: baseline (i.e. Imaging visit) and at the end of study visit (day 7 to day 14)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
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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.
Rajan Rakheja principal investigator
University of Saskatchewan
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 68Ga-PSMA PET/CT in people with Prostate Cancer, run by University of Saskatchewan 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 6 inclusion and 3 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: paused, as of the sponsor's last update on 2 May 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 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?
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?
Sensitivity and specificity of 68Ga-PSMA-11 PET/CT compared to that of CT alone and bone scan in two different cohorts of prostrate cancer patients. (time frame: 6 months). 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 2 May 2024.