68Ga-PSMA-11 PET/MRI for Selecting Men With Prostate Cancer for Focal Therapy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity Health Network, Toronto
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 design
Design model
Single group
Treatments tested in this trial
Gallium Ga 68 Gozetotide (68Ga-PSMA-11)
DrugIntervention 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 lesions
Diagnostic testGallium 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.
Treatment groups
8 Participants
are divided into 1 treatment groupGroup A: 68Ga-PSMA-11 PET/MRI ImagingExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Through study completion, an average of 1 yearSecondary 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.
Time frame
Through study completion, an average of 1 yearOther outcomes
1
Primary Endpoint:
Lesions identified by PSMA PET/MRI or MRI alone will be compared to histopathology after radical prostatectomy as reference standard (the hypothesis being that PET/MRI will exclude more patients from Focal Therapy who would be considered ineligible for FT by histopathology).
Time frame
Through study completion, an average of 1 yearSponsors and contacts
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Source ClinicalTrials.gov
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