None listed
Conditions
Brief summary
The purpose of this study is to examine the diagnostic accuracy of a non-invasive PET scan in the context of prostate cancer. Who is it for? You may be eligible for this study if you are over 18, have an elevated PSA or abnormal DRE, are scheduled to or have undergone a prostate MRI and are considering a prostate biopsy. Study details All participants in this study will undergo an additional PET scan prior to their scheduled biopsy. If prostate lesions are identified on this scan, they will be targeted at the time of biopsy. It is hoped this research will help to reduce unnecessary prostate biopsies in men being investigated for prostate cancer, by identifying situations where a biopsy is required more precisely.
Interventions
A single pre-biopsy pelvic gallium 68 prostate specific membrane antigen positron emission tomography (68Ga-PSMA PET) will be performed, 68Ga-PSMA (H-BED CC-11) 2.0mbq/kg will be administered. A limited field of view PSMA PET of the pelvis (6 minutes/bed stop) will be undertaken a minimum 60 minutes post injection with a non-contrast-enhanced CT scan (pelvis) performed 60 minutes post tracer injection using the following CT parameters: 2 mm slice thickness soft tissue reconstruction kernel, 120
A single pre-biopsy pelvic gallium 68 prostate specific membrane antigen positron emission tomography (68Ga-PSMA PET) will be performed, 68Ga-PSMA (H-BED CC-11) 2.0mbq/kg will be administered. A limited field of view PSMA PET of the pelvis (6 minutes/bed stop) will be undertaken a minimum 60 minutes post injection with a non-contrast-enhanced CT scan (pelvis) performed 60 minutes post tracer injection using the following CT parameters: 2 mm slice thickness soft tissue reconstruction kernel, 120 keV and 50 mAs, pitch of 0·828, 600 mm FOV and a 512 matrix and interpreted by specialist nuclear medicine physicians at a centralised location (Sydney - St Vincent's Public Hospital, Melbourne - Peter MacCallum Cancer Centre). This will occur within 8 weeks of initial referral for investigation of prostate cancer, prior to a template transperineal biopsy. The mpMRI will also occur prior to biopsy, and can occur before or after the PSMA PET.
Sponsors
St Vincent's Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
•Male, aged 18 years or over •Suspicion or prostate cancer with either an abnormal DRE OR PSA greater than age specific reference range on two or more occasions •No previously diagnosed prostate cancer •No previous prostate biopsies •Has undergone an mpMRI within the last 6 months, or scheduled to undergo an mpMRI prior to biopsy •Ability to give written informed consent, participate in and comply with the study
Exclusion criteria
• Previous diagnosis of PCa • Previous prostate biopsies • Inability/ incapacity to provide own consent • PSA >20ng/ml • greater than or equal to cT3 on DRE • Contraindication to MRI, including but not restricted to: o Pacemaker or other electronic implant o Allergy or contraindiation to MRI contrast, e.g. renal failure (eGFR <30mL/min) o Shrapnel, tattoos, non-removable body piercings (relative contraindication)
Outcome results
None listed