Prostatic NeoplasmNCT04484701
[68Ga]Ga-PSMA-11 PET/CT in the Assessment of High Risk and Recurrent Prostate Cancer
An observational study of Prostatic Neoplasm and Prostatic Cancer, run by British Columbia Cancer Agency at 1 site in Canada.
Trial summary
Prostate cancer is the third most common cause of cancer death in men. Most patients with localized prostate cancer will be cured with surgery or radiation therapy, but up to 35% of patients will have their prostate cancer return. Read more about this study
- Who is it for?
- Ages 19 to 99 years, men only
- Conditions the study is for
- Prostatic Neoplasm, Prostatic Cancer
- What is being tested?
- 68Ga-PSMA-11
- How many people
- 1,574 participants
- Where
- 1 siteCanada
- Study dates
- 1 Feb 2021to Sep 2028
- How long will I take part?
- 5 Years
- Phase
- Observational
- 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 19 to 99 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with high risk prostate cancer at initial presentation (CAPRA score 6 or higher), subjects with biochemical persistence of prostate cancer following radical prostatectomy, subjects with biochemical recurrence of prostate cancer following initial curative treatment with radical prostatectomy or radiation therapy, subjects with biochemical recurrence of prostate cancer following radical prostatectomy who received subsequent salvage radiotherapy, and subjects with advanced prostate cancer (castration sensitive or castration resistant disease that is metastatic with conventional imaging, castration resistant disease that is non-metastatic on conventional imaging).
Who may be able to join
- Eastern Cooperative Oncology Group performance status of 2 or less.
- Subjects with high risk prostate cancer (CAPRA score 6 or higher) being considered for curative-intent surgery or radiation therapy (including brachytherapy)
- Subjects with biopsy confirmed prostate cancer being considered for curative-intent surgery or radiation therapy (including brachytherapy), who have unconfirmed suspicious findings on conventional medical imaging staging examinations.
- 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.
- 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.
- 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.
- 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).
- 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).
Who cannot join
- Medically unstable (e.g. acute illness, unstable vital signs)
- Unable to lie supine for the duration of imaging
- Unable to provide written consent
- Exceeds safe weight limit of the PET/CT bed (204.5 kg) or unable to fit through the PET/CT bore (diameter 70 cm)
- Exclusion criteria for the use of furosemide Subjects can still participate in the research study and undergo the [68Ga]Ga-PSMA-11 scan if they are unable or unwilling to receive a furosemide injection.
- Subjects with end stage renal disease.
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- Subjects with documented history of severe progressive chronic kidney disease (glomerular filtration rate less than 30 mL/min/1.73 m2).
- Subjects with hypersensitivity to furosemide (Lasix).
- While cross-reactivity between sulfonamide antibiotics and non-antibiotics has been disproven, subjects who have a history of sulfonamide antibiotics or sulfonylureas may be at a higher risk of allergic reaction to furosemide due to a higher general predisposition to allergic reactions. In those instances, the administration of furosemide is left at the discretion of the local site investigator after discussion with the study subject.
- Subjects with severe hypokalemia, hyponatremia, hypovolemia, dehydration or hypotension.
- Subjects with untreated bladder outlet obstruction or lower urinary tract symptoms, who have a history of obstructive episodes that required hospitalization, emergency department visits and/or bladder catheterization for relief of symptoms.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 68Ga-PSMA-11 Positron Emission Tomography / Computed Tomography (PET/CT) for Assessment of High Risk or Recurrent Prostate Cancer
Prostate cancer is the third most common cause of cancer death in men. Most patients with localized prostate cancer will be cured with surgery or radiation therapy, but up to 35% of patients will have their prostate cancer return. Whether it has returned locally or distantly determines which type of treatment they will receive. Current conventional imaging modalities have limitations particularly at low prostate specific antigen levels. This study proposes to use Gallium-68-PSMA-11 (68Ga-PSMA-11) Positron Emission Tomography / Computer Tomography (PET/CT) scans which targets prostate-specific membrane antigens (PSMA) to detect where in the body the prostate cancer has recurred.
Read the detailed description
This is a prospective registry study to evaluate the diagnostic utility of 68Ga-PSMA-11 PET/CT to stage patients with high risk prostate cancer, localize sites of biochemical recurrence of prostate cancer, and restage patients with advanced prostate cancer before and after onset of new therapy.
Eligible subjects will undergo a 68Ga-PSMA-11 PET/CT at the British Columbia Cancer (BCC) - Vancouver. Each subject will receive a 68Ga-PSMA-11 PET/CT scan at the BCC - Vancouver, as part of this research study. Each study subject will receive a bolus intravenous dose of 68Ga-PSMA-11. The subject will rest in a comfortable chair for 60 minutes and will then be taken to the PET/CT scanner for images. The PET/CT scan will take approximately 2.5 hours of patient time above and beyond the time needed for standard of care.
Medical History Questionnaire: Demographic and medical history data will be collected either in person before the PET scan appointment or by mail or phone, whichever is the most convenient to the subject.
Follow-up assessments: All subjects will be contacted by phone the day after the injection of 68Ga-PSMA-11. The subjects will be asked if they experienced any undesirable effects during the 12 hours after the administration of 68Ga-PSMA-11. The local site attending nuclear medicine physician will then make an assessment as to whether these effects are likely related to 68Ga-PSMA-11 administration.
All subjects will be followed for 5 years following the 68Ga-PSMA-11 PET/CT exam to assess the presence of recurrence. The evaluation will include a chart review of available imaging, laboratory tests, and treatment. The data required can be obtained from a review of the patient's paper and electronic charts, supplemented by telephone contact as needed to complete the information.
- Conditions
- Prostatic Neoplasm, Prostatic Cancer
- Being tested
- 68Ga-PSMA-11
- 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-11Drug
PET/CT scan with radiotracer 68Ga-PSMA-11
| Study group | Role | What they receive |
|---|---|---|
| PSMA-11 PET/CT scan | All participants will undergo the same procedures listed in "Detailed Description" in the protocol section. Receives: Drug: 68Ga-PSMA-11 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of 68Ga-PSMA-11 PET/CT imaging in the assessment of high risk and recurrent prostate cancer.
Determination of sensitivity when compared with pathology reports (if available) and routine imaging (CT, MRI, bone scan) if available.
Measured: 5 years after PSMA-11 PET/CT scan
Secondary outcomes (4)
Predictive value of 68Ga-PSMA-11 PET/CT imaging
The clinical predictive value will be assessed by multivariate analysis, using a Cox proportional hazard model, including established clinical parameters at initial presentation or relapse for the 5 most active lesions.
Measured: 5 years after the PSMA PET scan
Accuracy of 68Ga-PSMA-11 PET/CT imaging
The accuracy (along with the confidence interval) of 68Ga-PSMA-11 will be calculated for subjects with an available gold standard.
The gold standard for the detection of lesions will be established through a combination of: 1) pathology results following surgical resection; 2) disease progression of specific 68Ga-PSMA-11 findings on clinical or conventional imaging follow-up; 3) unequivocal disease response of specific 68Ga-PSMA-11 findings on conventional imaging follow-up after treatment; 4) decrease of PSA level after targeted radiation of 68Ga-PSMA-11 findings; 5) progression of 68Ga-PSMA-11 findings on subsequent 68Ga-PSMA-11 imaging associated with a concurrent increase in PSA level; 6) regression of [68Ga]Ga-PSMA-11 findings on subsequent [68Ga]Ga-PSMA-11 imaging associated with a concurrent decrease in PSA level.
Measured: 5 years after the PSMA PET scan
Specificity of 68Ga-PSMA-11 PET/CT imaging
The specificity (along with the confidence interval) of [68Ga]Ga-PSMA-11 will be calculated for subjects with an available gold standard (see above for definition).
Measured: 5 years after the PSMA PET scan
Number of participants with self-reported 68Ga-PSMA-11-related adverse event
Patients will be contacted by phone the day after the 68Ga-PSMA-11 PET/CT scan to see if they experienced any adverse events in the 12 hours following the 68Ga-PSMA-11 injection. These are recorded and evaluated for severity and likelihood they are related to the study drug. All adverse events will be recorded and summarized in the final report.
Measured: 12 hours post 68Ga-PSMA-11 injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start1 Feb 2021
- Primary completionMay 2026 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmStudies of the same condition, open and under way.
- More trials run by British Columbia Cancer AgencyThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,574 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- British Columbia Cancer Agency
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francois Benard, MD, Principal investigator, BC Cancer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04484701
- Sponsor's protocol ID
- H20-01325
- Status last verified
- May 2025
- First submitted
- 21 Jul 2020
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan.
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 68Ga-PSMA-11 Positron Emission Tomography / Computed Tomography (PET/CT) for Assessment of High Risk or Recurrent Prostate Cancer
- ClinicalTrials.gov ID
- NCT04484701
- Acronym / sponsor ID
- H20-01325
- Conditions
- Prostatic Neoplasm, Prostatic Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,574 participants (estimated)
- Lead sponsor
- British Columbia Cancer AgencyUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 23 Jul 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.
Prostate cancer is the third most common cause of cancer death in men. Most patients with localized prostate cancer will be cured with surgery or radiation therapy, but up to 35% of patients will have their prostate cancer return. Whether it has returned locally or distantly determines which type of treatment they will receive. Current conventional imaging modalities have limitations particularly at low prostate specific antigen levels. This study proposes to use Gallium-68-PSMA-11 (68Ga-PSMA-11) Positron Emission Tomography / Computer Tomography (PET/CT) scans which targets prostate-specific membrane antigens (PSMA) to detect where in the body the prostate cancer has recurred.
Detailed description
This is a prospective registry study to evaluate the diagnostic utility of 68Ga-PSMA-11 PET/CT to stage patients with high risk prostate cancer, localize sites of biochemical recurrence of prostate cancer, and restage patients with advanced prostate cancer before and after onset of new therapy.
Eligible subjects will undergo a 68Ga-PSMA-11 PET/CT at the British Columbia Cancer (BCC) - Vancouver. Each subject will receive a 68Ga-PSMA-11 PET/CT scan at the BCC - Vancouver, as part of this research study. Each study subject will receive a bolus intravenous dose of 68Ga-PSMA-11. The subject will rest in a comfortable chair for 60 minutes and will then be taken to the PET/CT scanner for images. The PET/CT scan will take approximately 2.5 hours of patient time above and beyond the time needed for standard of care.
Medical History Questionnaire: Demographic and medical history data will be collected either in person before the PET scan appointment or by mail or phone, whichever is the most convenient to the subject.
Follow-up assessments: All subjects will be contacted by phone the day after the injection of 68Ga-PSMA-11. The subjects will be asked if they experienced any undesirable effects during the 12 hours after the administration of 68Ga-PSMA-11. The local site attending nuclear medicine physician will then make an assessment as to whether these effects are likely related to 68Ga-PSMA-11 administration.
All subjects will be followed for 5 years following the 68Ga-PSMA-11 PET/CT exam to assess the presence of recurrence. The evaluation will include a chart review of available imaging, laboratory tests, and treatment. The data required can be obtained from a review of the patient's paper and electronic charts, supplemented by telephone contact as needed to complete the information.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PSMA-11 PET/CT scan | – | Drug: 68Ga-PSMA-11All participants will undergo the same procedures listed in "Detailed Description" in the protocol section. |
Who may qualify
- Ages
- 19 to 99 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with high risk prostate cancer at initial presentation (CAPRA score 6 or higher), subjects with biochemical persistence of prostate cancer following radical prostatectomy, subjects with biochemical recurrence of prostate cancer following initial curative treatment with radical prostatectomy or radiation therapy, subjects with biochemical recurrence of prostate cancer following radical prostatectomy who received subsequent salvage radiotherapy, and subjects with advanced prostate cancer (castration sensitive or castration resistant disease that is metastatic with conventional imaging, castration resistant disease that is non-metastatic on conventional imaging).
Key inclusion criteria (8 listed)
- Eastern Cooperative Oncology Group performance status of 2 or less.
- Subjects with high risk prostate cancer (CAPRA score 6 or higher) being considered for curative-intent surgery or radiation therapy (including brachytherapy)
- Subjects with biopsy confirmed prostate cancer being considered for curative-intent surgery or radiation therapy (including brachytherapy), who have unconfirmed suspicious findings on conventional medical imaging staging examinations.
- 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.
- 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.
Key exclusion criteria (11 listed)
- Medically unstable (e.g. acute illness, unstable vital signs)
- Unable to lie supine for the duration of imaging
- Unable to provide written consent
- Exceeds safe weight limit of the PET/CT bed (204.5 kg) or unable to fit through the PET/CT bore (diameter 70 cm)
- Exclusion criteria for the use of furosemide Subjects can still participate in the research study and undergo the [68Ga]Ga-PSMA-11 scan if they are unable or unwilling to receive a furosemide injection.
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-11PET/CT scan with radiotracer 68Ga-PSMA-11 | Drug | PSMA-11 PET/CT scan |
Primary outcome
Sensitivity of 68Ga-PSMA-11 PET/CT imaging in the assessment of high risk and recurrent prostate cancer.
Time frame: 5 years after PSMA-11 PET/CT scan
Determination of sensitivity when compared with pathology reports (if available) and routine imaging (CT, MRI, bone scan) if available.
4 secondary outcomes
Predictive value of 68Ga-PSMA-11 PET/CT imaging
Time frame: 5 years after the PSMA PET scan
Accuracy of 68Ga-PSMA-11 PET/CT imaging
Time frame: 5 years after the PSMA PET scan
Specificity of 68Ga-PSMA-11 PET/CT imaging
Time frame: 5 years after the PSMA PET scan
Number of participants with self-reported 68Ga-PSMA-11-related adverse event
Time frame: 12 hours post 68Ga-PSMA-11 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 9 May 2025.
- Individual participant dataSharing planned: No. No plan.
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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.
Francois Benard, MD principal investigator
BC Cancer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostatic Neoplasm and Prostatic Cancer, run by British Columbia Cancer Agency 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 8 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 9 May 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.
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?
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 of 68Ga-PSMA-11 PET/CT imaging in the assessment of high risk and recurrent prostate cancer. (time frame: 5 years after PSMA-11 PET/CT scan). 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 9 May 2025.