Prostate Cancer (Adenocarcinoma)PSMA-FTNCT07747493
68Ga-PSMA-11 PET/MRI for Selecting Men With Prostate Cancer for Focal Therapy
A study testing Gallium Ga 68 Gozetotide (68Ga-PSMA-11) and Intervention Description: Integrated positron emission tomography/magnetic resonance imaging (PET/MRI) combines molecular imaging with high-resolution anatomical MRI to evaluate intraprostatic lesions in people with Prostate Cancer (Adenocarcinoma) and Localized Prostate Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Focal therapy is a minimally invasive treatment option for some men with localized prostate cancer. Unlike surgery or radiation, focal therapy treats only the area of the prostate containing clinically significant cancer, with the goal of preserving urinary and sexual function. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer (Adenocarcinoma), Localized Prostate Cancer
- What is being tested?
- Gallium Ga 68 Gozetotide (68Ga-PSMA-11) and Intervention Description: Integrated positron emission tomography/magnetic resonance imaging (PET/MRI) combines molecular imaging with high-resolution anatomical MRI to evaluate intraprostatic lesions
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2026to 31 Dec 2027
- Phase
- Interventional
- 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
- Ability to provide written informed consent.
- Age 18 years or older.
- Clinically significant prostate cancer (csPCa) with clinical stage ≤ T2c and planned radical prostatectomy.
- Serum prostate-specific antigen (PSA) ≤ 20 ng/mL.
- Clinically significant prostate cancer within an MRI-visible lesion, defined as - International Society of Urological Pathology (ISUP) Grade Group 2 or 3 (Gleason score 3+4 or 4+3) in any biopsy core.
Who cannot join
- Inability to lie still for the PET/MRI examination.
- Known contraindication or hypersensitivity to gallium Ga 68 gozetotide (68Ga-PSMA-11) or to the MRI gadolinium contrast agent, including any component of the formulation.
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
University Health Network - Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
Adriano Basso Dias, MD, Radiologist, 1-647-504-4609, adriano.bassodias@uhn.ca
Kateri Corr, 416-946-4501 ext. 5501, kateri.corr@uhn.ca
About this study
Official title: The Role of 68Ga-PSMA-11 PSMA PET/MRI in Selecting Patients With Prostate Cancer for Focal Therapy: A Pilot Study
Focal therapy is a minimally invasive treatment option for some men with localized prostate cancer. Unlike surgery or radiation, focal therapy treats only the area of the prostate containing clinically significant cancer, with the goal of preserving urinary and sexual function. Successful focal therapy depends on accurately identifying all areas of clinically significant prostate cancer before treatment. Currently, multiparametric magnetic resonance imaging (MRI) is the standard imaging method used to determine whether a patient is a suitable candidate for focal therapy. However, MRI may miss some clinically significant cancers, which can lead to incomplete treatment.
This pilot study will evaluate whether 68Ga-PSMA-11 positron emission tomography/magnetic resonance imaging (PET/MRI) can improve the selection of men with localized prostate cancer for focal therapy compared with MRI alone. The study will enroll men with intermediate-risk prostate cancer who are already planning to undergo radical prostatectomy as part of their standard care.
Read more
Participants will receive a single injection of 68Ga-PSMA-11 followed by a PET/MRI scan before surgery. The PET/MRI findings and MRI findings will be reviewed separately and compared with the prostate tissue examined after surgery, which serves as the reference standard for determining the true location and extent of cancer.
The main question this study is trying to answer is whether 68Ga-PSMA-11 PET/MRI is more accurate than MRI alone in identifying men who are appropriate candidates for focal therapy. The study will also evaluate whether PET/MRI detects more clinically significant prostate cancer lesions than MRI alone.
Researchers hypothesize that 68Ga-PSMA-11 PET/MRI will improve the detection of clinically significant prostate cancer and more accurately identify patients who are suitable candidates for focal therapy, potentially reducing the risk of untreated cancer remaining in the prostate after treatment. If successful, the results of this pilot study will support the development of a larger clinical trial and may help improve future treatment planning for men with localized prostate cancer.
Read the detailed description
Prostate cancer is one of the most commonly diagnosed cancers in men. For patients with localized, clinically significant disease, focal therapy has emerged as a minimally invasive treatment option that targets only the cancerous portion of the prostate while preserving surrounding healthy tissue. Compared with whole-gland treatments such as radical prostatectomy or radiation therapy, focal therapy has the potential to reduce treatment-related side effects, including urinary incontinence and erectile dysfunction, while maintaining cancer control in appropriately selected patients.
The success of focal therapy depends on accurately identifying all clinically significant prostate cancer within the prostate before treatment. Multiparametric magnetic resonance imaging (MRI) is currently the standard imaging modality used to evaluate patients being considered for focal therapy. Although MRI has substantially improved prostate cancer detection and localization, clinically significant tumors may remain undetected. Failure to identify all clinically significant disease may result in incomplete treatment, persistent cancer outside the treated area, or disease recurrence following focal therapy.
Prostate-specific membrane antigen (PSMA) is a protein that is highly expressed on the surface of most prostate cancer cells. Radiotracers that target PSMA, such as 68Ga-PSMA-11, allow prostate cancer lesions to be visualized using positron emission tomography (PET). When PET is combined with MRI in a hybrid PET/MRI scanner, molecular information from PET is integrated with the high-resolution anatomical detail provided by MRI. Previous studies have demonstrated that combining PSMA PET with MRI improves the detection of clinically significant prostate cancer compared with MRI alone, but the value of this approach for selecting patients for focal therapy has not been established.
This prospective pilot study will evaluate the diagnostic performance of 68Ga-PSMA-11 PET/MRI compared with MRI alone in men with localized intermediate-risk prostate cancer who have already elected to undergo radical prostatectomy as part of their standard clinical care. Because the prostate gland will subsequently be removed, detailed whole-mount histopathological examination of the surgical specimen can be used as the reference standard to determine the true location and extent of cancer throughout the prostate. This provides a unique opportunity to directly compare imaging findings with pathology.
Imaging findings from MRI alone and from integrated PET/MRI will be independently interpreted and compared with whole-mount histopathology to determine how each imaging strategy would influence patient selection for focal therapy. The study will assess whether additional lesions detected by PET/MRI would alter eligibility for focal therapy or require modification of the planned treatment strategy. The analysis will evaluate theoretical focal therapy approaches, including targeted, zonal, and hemi-gland ablation, based on the distribution of clinically significant disease identified on surgical pathology. Participants will not receive focal therapy as part of this study, and PET/MRI findings will not influence their clinical management.
The investigators hypothesize that 68Ga-PSMA-11 PET/MRI will improve identification of clinically significant prostate cancer compared with MRI alone and more accurately identify patients who are appropriate candidates for focal therapy. Improved patient selection has the potential to reduce treatment failures caused by undetected cancer outside the intended treatment area while preserving the quality-of-life benefits associated with focal therapy.
As a pilot feasibility study, the results will provide preliminary evidence to inform the design of a larger prospective clinical trial. If the findings demonstrate improved diagnostic performance, 68Ga-PSMA-11 PET/MRI may become an important imaging tool for patient selection in future focal therapy programs and clinical trials, ultimately supporting more individualized treatment planning for men with localized prostate cancer.
- Being tested
- Gallium Ga 68 Gozetotide (68Ga-PSMA-11), Intervention Description: Integrated positron emission tomography/magnetic resonance imaging (PET/MRI) combines molecular imaging with high-resolution anatomical MRI to evaluate intraprostatic lesions
- Keywords
- Prostate Cancer, Gallium Ga 68 Gozetotide, Positron Emission Tomography Magnetic Resonance Imaging, Multiparametric Magnetic Resonance Imaging, Focal Therapy, Localized Prostate Cancer, Intermediate-Risk Prostate Cancer, Radical Prostatectomy, Diagnostic Imaging
- Medical subject headings
- Prostatic Neoplasms, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gallium Ga 68 Gozetotide (68Ga-PSMA-11)Drug
Also called Diagnostic Test
Intervention Description: Gallium Ga 68 gozetotide (68Ga-PSMA-11) is a prostate-specific membrane antigen (PSMA)-targeted positron-emitting radiopharmaceutical used for PET imaging of prostate cancer. In this study, a single intravenous dose (111-259 MBq) will be administered before PET/MRI to evaluate its diagnostic performance for identifying clinically significant prostate cancer and improving selection of patients for focal therapy.
Intervention Description: Integrated positron emission tomography/magnetic resonance imaging (PET/MRI) combines molecular imaging with high-resolution anatomical MRI to evaluate intraprostatic lesionsDiagnostic test
Gallium Ga 68 gozetotide (68Ga-PSMA-11) is a prostate-specific membrane antigen (PSMA)-targeted positron-emitting radiopharmaceutical approved for PET imaging of PSMA-expressing lesions in men with prostate cancer. In this study, it is administered as a single intravenous injection (111-259 MBq) before PET/MRI to evaluate its ability to improve detection of clinically significant intraprostatic disease and selection of patients for focal therapy compared with multiparametric MRI alone.
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-PSMA-11 PET/MRI Imaging | Experimental | Participants will receive a single intravenous administration of gallium Ga 68 gozetotide (68Ga-PSMA-11) (111-259 MBq) followed by integrated positron emission tomography/magnetic resonance imaging (PET/MRI) approximately 50-100 minutes after injection. PET/MRI findings will be compared with multiparametric MRI alone and whole-mount histopathology following planned radical prostatectomy to evaluate the diagnostic performance of 68Ga-PSMA-11 PET/MRI for selecting men with localized intermediate-risk prostate cancer for focal therapy. PET/MRI results will not influence clinical management, and all participants will proceed with standard-of-care radical prostatectomy. Receives: Drug: Gallium Ga 68 Gozetotide (68Ga-PSMA-11); Diagnostic Test: Intervention Description: Integrated positron emission tomography/magnetic resonance imaging (PET/MRI) combines molecular imaging with high-resolution anatomical MRI to evaluate intraprostatic lesions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specificity of 68Ga-PSMA-11 PET/MRI for Determining Eligibility for Focal Therapy
To evaluate the specificity of 68Ga-PSMA-11 PET/MRI compared with multiparametric MRI alone for determining eligibility for focal therapy in men with localized intermediate-risk prostate cancer. Imaging findings will be compared with whole-mount histopathology following radical prostatectomy, which serves as the reference standard.
Measured: Through study completion, an average of 1 year
Secondary outcomes (1)
Detection Rate of 68Ga-PSMA-11 PET/MRI for Clinically Significant Prostate Cancer
To evaluate the detection rate of 68Ga-PSMA-11 PET/MRI compared with multiparametric MRI alone for identifying clinically significant prostate cancer (International Society of Urological Pathology [ISUP] Grade Group ≥2) in men with localized intermediate-risk prostate cancer who are potential candidates for focal therapy. The outcome will be measured as the percentage of lesions correctly identified by each imaging modality using whole-mount histopathology following radical prostatectomy as the reference standard.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate Cancer (Adenocarcinoma)Studies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-group, prospective diagnostic imaging study in which all participants receive the same study intervention, consisting of intravenous administration of gallium Ga 68 gozetotide (68Ga-PSMA-11) followed by PET/MRI before planned radical prostatectomy. Each participant serves as their own control, with PET/MRI findings compared with multiparametric MRI alone and whole-mount histopathology to evaluate diagnostic performance for selecting patients for focal therapy.
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adriano Basso Dias, MD, MSc, Radiologist, Principal investigator, University Health Network - Toronto General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07747493
- Sponsor's protocol ID
- 23-5473
- Acronym
- PSMA-FT
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 5 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of 68Ga-PSMA-11 PSMA PET/MRI in Selecting Patients With Prostate Cancer for Focal Therapy: A Pilot Study
- ClinicalTrials.gov ID
- NCT07747493
- Acronym / sponsor ID
- PSMA-FT / 23-5473
- Keywords
- Prostate Cancer, Gallium Ga 68 Gozetotide, Positron Emission Tomography Magnetic Resonance Imaging, Multiparametric Magnetic Resonance Imaging, Focal Therapy, Localized Prostate Cancer, Intermediate-Risk Prostate Cancer, Radical Prostatectomy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 5 Aug 2026 (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.
Focal therapy is a minimally invasive treatment option for some men with localized prostate cancer. Unlike surgery or radiation, focal therapy treats only the area of the prostate containing clinically significant cancer, with the goal of preserving urinary and sexual function. Successful focal therapy depends on accurately identifying all areas of clinically significant prostate cancer before treatment. Currently, multiparametric magnetic resonance imaging (MRI) is the standard imaging method used to determine whether a patient is a suitable candidate for focal therapy. However, MRI may miss some clinically significant cancers, which can lead to incomplete treatment.
This pilot study will evaluate whether 68Ga-PSMA-11 positron emission tomography/magnetic resonance imaging (PET/MRI) can improve the selection of men with localized prostate cancer for focal therapy compared with MRI alone. The study will enroll men with intermediate-risk prostate cancer who are already planning to undergo radical prostatectomy as part of their standard care.
Participants will receive a single injection of 68Ga-PSMA-11 followed by a PET/MRI scan before surgery. The PET/MRI findings and MRI findings will be reviewed separately and compared with the prostate tissue examined after surgery, which serves as the reference standard for determining the true location and extent of cancer.
The main question this study is trying to answer is whether 68Ga-PSMA-11 PET/MRI is more accurate than MRI alone in identifying men who are appropriate candidates for focal therapy. The study will also evaluate whether PET/MRI detects more clinically significant prostate cancer lesions than MRI alone.
Researchers hypothesize that 68Ga-PSMA-11 PET/MRI will improve the detection of clinically significant prostate cancer and more accurately identify patients who are suitable candidates for focal therapy, potentially reducing the risk of untreated cancer remaining in the prostate after treatment. If successful, the results of this pilot study will support the development of a larger clinical trial and may help improve future treatment planning for men with localized prostate cancer.
Detailed description
Prostate cancer is one of the most commonly diagnosed cancers in men. For patients with localized, clinically significant disease, focal therapy has emerged as a minimally invasive treatment option that targets only the cancerous portion of the prostate while preserving surrounding healthy tissue. Compared with whole-gland treatments such as radical prostatectomy or radiation therapy, focal therapy has the potential to reduce treatment-related side effects, including urinary incontinence and erectile dysfunction, while maintaining cancer control in appropriately selected patients.
The success of focal therapy depends on accurately identifying all clinically significant prostate cancer within the prostate before treatment. Multiparametric magnetic resonance imaging (MRI) is currently the standard imaging modality used to evaluate patients being considered for focal therapy. Although MRI has substantially improved prostate cancer detection and localization, clinically significant tumors may remain undetected. Failure to identify all clinically significant disease may result in incomplete treatment, persistent cancer outside the treated area, or disease recurrence following focal therapy.
Prostate-specific membrane antigen (PSMA) is a protein that is highly expressed on the surface of most prostate cancer cells. Radiotracers that target PSMA, such as 68Ga-PSMA-11, allow prostate cancer lesions to be visualized using positron emission tomography (PET). When PET is combined with MRI in a hybrid PET/MRI scanner, molecular information from PET is integrated with the high-resolution anatomical detail provided by MRI. Previous studies have demonstrated that combining PSMA PET with MRI improves the detection of clinically significant prostate cancer compared with MRI alone, but the value of this approach for selecting patients for focal therapy has not been established.
This prospective pilot study will evaluate the diagnostic performance of 68Ga-PSMA-11 PET/MRI compared with MRI alone in men with localized intermediate-risk prostate cancer who have already elected to undergo radical prostatectomy as part of their standard clinical care. Because the prostate gland will subsequently be removed, detailed whole-mount histopathological examination of the surgical specimen can be used as the reference standard to determine the true location and extent of cancer throughout the prostate. This provides a unique opportunity to directly compare imaging findings with pathology.
Imaging findings from MRI alone and from integrated PET/MRI will be independently interpreted and compared with whole-mount histopathology to determine how each imaging strategy would influence patient selection for focal therapy. The study will assess whether additional lesions detected by PET/MRI would alter eligibility for focal therapy or require modification of the planned treatment strategy. The analysis will evaluate theoretical focal therapy approaches, including targeted, zonal, and hemi-gland ablation, based on the distribution of clinically significant disease identified on surgical pathology. Participants will not receive focal therapy as part of this study, and PET/MRI findings will not influence their clinical management.
The investigators hypothesize that 68Ga-PSMA-11 PET/MRI will improve identification of clinically significant prostate cancer compared with MRI alone and more accurately identify patients who are appropriate candidates for focal therapy. Improved patient selection has the potential to reduce treatment failures caused by undetected cancer outside the intended treatment area while preserving the quality-of-life benefits associated with focal therapy.
As a pilot feasibility study, the results will provide preliminary evidence to inform the design of a larger prospective clinical trial. If the findings demonstrate improved diagnostic performance, 68Ga-PSMA-11 PET/MRI may become an important imaging tool for patient selection in future focal therapy programs and clinical trials, ultimately supporting more individualized treatment planning for men with localized prostate cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-group, prospective diagnostic imaging study in which all participants receive the same study intervention, consisting of intravenous administration of gallium Ga 68 gozetotide (68Ga-PSMA-11) followed by PET/MRI before planned radical prostatectomy. Each participant serves as their own control, with PET/MRI findings compared with multiparametric MRI alone and whole-mount histopathology to evaluate diagnostic performance for selecting patients for focal therapy.
| Arm | Type | Receives |
|---|---|---|
| 68Ga-PSMA-11 PET/MRI Imaging | Experimental | Drug: Gallium Ga 68 Gozetotide (68Ga-PSMA-11), Diagnostic Test: Intervention Description: Integrated positron emission tomography/magnetic resonance imaging (PET/MRI) combines molecular imaging with high-resolution anatomical MRI to evaluate intraprostatic lesionsParticipants will receive a single intravenous administration of gallium Ga 68 gozetotide (68Ga-PSMA-11) (111-259 MBq) followed by integrated positron emission tomography/magnetic resonance imaging (PET/MRI) approximately 50-100 minutes after injection. PET/MRI findings will be compared with multiparametric MRI alone and whole-mount histopathology following planned radical prostatectomy to evaluate the diagnostic performance of 68Ga-PSMA-11 PET/MRI for selecting men with localized intermediate-risk prostate cancer for focal therapy. PET/MRI results will not influence clinical management, and all participants will proceed with standard-of-care radical prostatectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ability to provide written informed consent.
- Age 18 years or older.
- Clinically significant prostate cancer (csPCa) with clinical stage ≤ T2c and planned radical prostatectomy.
- Serum prostate-specific antigen (PSA) ≤ 20 ng/mL.
- Clinically significant prostate cancer within an MRI-visible lesion, defined as - International Society of Urological Pathology (ISUP) Grade Group 2 or 3 (Gleason score 3+4 or 4+3) in any biopsy core.
Key exclusion criteria (2 listed)
- Inability to lie still for the PET/MRI examination.
- Known contraindication or hypersensitivity to gallium Ga 68 gozetotide (68Ga-PSMA-11) or to the MRI gadolinium contrast agent, including any component of the formulation.
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 |
|---|---|---|
| Gallium Ga 68 Gozetotide (68Ga-PSMA-11)Also: Diagnostic TestIntervention Description: Gallium Ga 68 gozetotide (68Ga-PSMA-11) is a prostate-specific membrane antigen (PSMA)-targeted positron-emitting radiopharmaceutical used for PET imaging of prostate cancer. In this study, a single intravenous dose (111-259 MBq) will be administered before PET/MRI to evaluate its diagnostic performance for identifying clinically significant prostate cancer and improving selection of patients for focal therapy. | Drug | 68Ga-PSMA-11 PET/MRI Imaging |
| Intervention Description: Integrated positron emission tomography/magnetic resonance imaging (PET/MRI) combines molecular imaging with high-resolution anatomical MRI to evaluate intraprostatic lesionsGallium Ga 68 gozetotide (68Ga-PSMA-11) is a prostate-specific membrane antigen (PSMA)-targeted positron-emitting radiopharmaceutical approved for PET imaging of PSMA-expressing lesions in men with prostate cancer. In this study, it is administered as a single intravenous injection (111-259 MBq) before PET/MRI to evaluate its ability to improve detection of clinically significant intraprostatic disease and selection of patients for focal therapy compared with multiparametric MRI alone. | Diagnostic test | 68Ga-PSMA-11 PET/MRI Imaging |
Primary outcome
Specificity of 68Ga-PSMA-11 PET/MRI for Determining Eligibility for Focal Therapy
Time frame: Through study completion, an average of 1 year
To evaluate the specificity of 68Ga-PSMA-11 PET/MRI compared with multiparametric MRI alone for determining eligibility for focal therapy in men with localized intermediate-risk prostate cancer. Imaging findings will be compared with whole-mount histopathology following radical prostatectomy, which serves as the reference standard.
1 secondary outcome
Detection Rate of 68Ga-PSMA-11 PET/MRI for Clinically Significant Prostate Cancer
Time frame: Through study completion, an average of 1 year
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 5 Aug 2026.
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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.
Adriano Basso Dias, MD, MSc, Radiologist principal investigator
University Health Network - Toronto General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gallium Ga 68 Gozetotide (68Ga-PSMA-11) and Intervention Description: Integrated positron emission tomography/magnetic resonance imaging (PET/MRI) combines molecular imaging with high-resolution anatomical MRI to evaluate intraprostatic lesions in people with Prostate Cancer (Adenocarcinoma) and Localized Prostate Cancer, run by University Health Network, Toronto 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 5 inclusion and 2 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: opening soon, as of the sponsor's last update on 5 Aug 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.
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 Kateri Corr (1-416-500-5737, kateri.corr@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Specificity of 68Ga-PSMA-11 PET/MRI for Determining Eligibility for Focal Therapy (time frame: Through study completion, an average of 1 year). 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 5 Aug 2026.