None listed
Conditions
Brief summary
This study aims to determine the accuracy of an imaging technique, known as PSMA PET/MRI scanning, in detecting, diagnosing and characterising prostate cancer lesions. Who is it for? You may be eligible to join this study if you are a male aged 18 years or above and have new biopsy diagnosed prostate cancer, for which you are eligible for definitive (surgical) treatment with a radical prostatectomy. Study details All participants in this study will undergo an extra scan in addition to standard clinical care (which includes a multiparametric prostate MRI scan and a Ga68 PSMA PET/CT scan). The additional scan is called PSMA positron emission tomography/magnetic resonance imaging (PET/MRI). It is done immediately after the participant has undergone the standard scans, and does not require any additional radiotracer to be injected. A PET/MRI nuclear medicine technologist will perform the scan, taking around 30 minutes to 1 hour, at a research imaging facility in metropolitan Melbourne. It is hoped that the additional scan will help to detect and characterise prostate cancer lesions and associated metastatic disease.
Interventions
Simultaneous hybrid positron emission tomography/magnetic resonance imaging (PET/MRI) scanning for prostate cancer using the Siemens Biograph mMR hybrid PET/MRI machine.
The intervention will involve using the already injected Ga68 PSMA radiotracer (dose is weight based) from standard clinical care to perform an additional PET/MRI scan. The scan is done immediately after the patient has undergone the control treatment, a Ga68 PSMA PET/CT scan, as part of standard clinical care. No additional ra
Simultaneous hybrid positron emission tomography/magnetic resonance imaging (PET/MRI) scanning for prostate cancer using the Siemens Biograph mMR hybrid PET/MRI machine. The intervention will involve using the already injected Ga68 PSMA radiotracer (dose is weight based) from standard clinical care to perform an additional PET/MRI scan. The scan is done immediately after the patient has undergone the control treatment, a Ga68 PSMA PET/CT scan, as part of standard clinical care. No additional radiotracer will need to be injected. The patient will travel to another facility containing the PET/MRI machine. A PET/MRI nuclear medicine technologist will perform the scan, and the images will be interpreted and reported by a nuclear medicine physician. The intervention will only be performed once, taking around 30 minutes to 1 hour, at a research imaging facility in metropolitan Melbourne.
Sponsors
Australian Urology Associates
Study design
Allocation
Non-randomised trial
Intervention model
Crossover
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion criteria: (1) adult 18 years of age and above with new transperineal/transrectal biopsy diagnosed prostate cancer (2) male sex (3) eligible for definitive treatment with radical prostatectomy (based on age, medical co-morbidities, past history, disease progression/severity, life expectancy or other factors), as determined by the treating urologist (4) eligible to undergo a Ga68 PSMA PET/CT scan as part of standard clinical care (5) biopsy diagnosed cancer is intermediate risk prostate cancer or higher (greater than or equal to Gleason 3+4=7 or Grade Group 2) (6) Signed, written, informed consent
Exclusion criteria
Exclusion criteria: (1) <18 years old (2) low risk prostate cancers (Less than or equal to Gleason 3+3=6 or Grade Group 1) (3) previously diagnosed prostate cancers (includes treated and untreated prostate cancers) (4) ineligible for definitive treatment with radical prostatectomy due to age, medical co-morbidities, past history, disease progression/severity, life expectancy or other factors as determined by the treating urologist (5) contraindications to injection of Gallium 68 labelled PSMA radiotracer, magnetic resonance imaging and PET/CT
Outcome results
None listed