None listed
Conditions
Brief summary
The primary purpose of this trial is to evaluate the comparative accuracy of different scans and biopsy diagnostic techniques for low risk prostate cancer. Who is it for? You may be eligible to enroll in this trial if you are aged 40 to 75 years and have been diagnosed with low risk prostate cancer, and with a life expectancy of at least 10 years. Study details All participants enrolled in this trial will receive a 68Ga-HBED-CC PSMA PET/MRI of the prostate and pelvis, which involves injection of a radioactive substance (68Ga-HBED-CC PSMA) following by lying in the scanner for 1-2 hours. All participants will then receive a transperineal biopsy of the prostate. Participants who have lesions identified on the 68Ga-HBED-CC PSMA PET/MRI scan will receive a biopsy procedure targeting those lesions when they have transperineal biopsy of the prostate. Researchers will then complete genetic analysis on the previous biopsy sample. The results of the scanning techniques, the biopsy result and the genetic testing score will all be compared to determine the most accurate technique for reclassifying men previously diagnosed with low risk prostate cancer into higher risk categories.
Interventions
Each participant will attend a 68Ga-PSMA PET/MR scan (combining PET and mpMRI), a transperineal template saturation prostate biopsy, a Biojet MRI USS Fusion transperineal prostate biopsy when having transperineal biopsy if lesions of interest are identified on the 68Ga-PSMA PET/MR scan, and will have a Prolaris Cell Cycle Progression test on previous samples.
[68Ga]Gallium-labelled prostate specific membrane antigen HBED-CC ligand (68Ga-PSMA)
It is an intravenous (IV) solution. The strength is
Each participant will attend a 68Ga-PSMA PET/MR scan (combining PET and mpMRI), a transperineal template saturation prostate biopsy, a Biojet MRI USS Fusion transperineal prostate biopsy when having transperineal biopsy if lesions of interest are identified on the 68Ga-PSMA PET/MR scan, and will have a Prolaris Cell Cycle Progression test on previous samples. [68Ga]Gallium-labelled prostate specific membrane antigen HBED-CC ligand (68Ga-PSMA) It is an intravenous (IV) solution. The strength is 150MBq. One infusion is needed for the scan. The infusion of the 68Ga-PSMA ligands takes about 45 mins. Then, 68Ga-PSMA PET/MR scan will be performed. The scan will take 1-2 hours. Multi Parameteric Magnetic Resonance Imaging (mpMRI) This type of scan does not use radiation. As in standard MRI, mpMRI uses magnetic signal to build up a picture of the prostate. However, in addition to this, mpMRI uses additional types of magnetic signals to build up more complete images of the prostate. This gives an overall assessment of the prostate and identifies areas of suspicion that can be targeted specifically for biopsy. Use of mpMRI approach increases the accuracy of the scan result and subsequent biopsy but we cannot be sure if this is the best approach without doing the study. Positron Emission Tomography (PET) PET scans are often used in the management of cancer and for diagnosis of suspected cancer conditions. This type of scan involves the use of a PET scanner and a radiotracer (radioactive agent). The PET radiotracer used in this study is 68Ga PSMA ligand which is a radioactive protein marker. PET scans may be performed with low dose whole body computer tomography or MRI. The new imaging we are proposing is a hybrid of the above two described techniques. Both will occur at the same within the same machine. As the images are taken at the same time, there is a potential for significant improvement in the quality of the imaging with improved higher grade cancer detection rate on subsequent biopsy. Biojet MRI USS Fusion Transperineal Prostate Biopsy It is a technology used to assist in biopsy the prostate. With the advent of mpMRI of the prostate, identification of lesions suspicious for high-grade cancer in the prostate for targeting is now possible with high accuracy. The Biojet technology allows fusion of the MRI and PSMA PET imaging previously performed to live Transrectal Ultrasound (TRUS) imaging in real-time (via a computer and provided software) in order to more accurately target lesions of interest. The biopsies are also performed via a transperineal approach (through the skin of the perineum between anus and base of scrotum) which allows more accurate localisation of lesions and better access to the anterior zones, with decreased potential infectious complications as a transrectal biopsy approach is avoided. These biopsies are performed under general anaesthetic at the Princess Alexandra Hospital within 3 months after the 68Ga-PSMA PET/MR scan. The biopsy procedure will take 45 min and will be performed by Urologists. Prolaris Cell Cycle Progression (CCP) Score It is a commercially available genetic test performed on the cancer sample obtained from the prostate biopsy. This test looks at the expression of 31 genes (termed cell cycle progression genes) normalized to 15 housekeeping genes in the cancer sample. This expression along with clinical information are used to calculate the CCP score which indicates how aggressively the individual cancer may behave in the future in comparison to other patients with similar clinical criteria. This may assist participants and the surgeon in the decision to continue on an Active Surveillance (AS) protocol or proceed with active treatment (surgery or radiation). This new test has never been compared with PSMA PET MRI imaging and fusion biopsy in its ability to accurately identify men with more aggressive cancer who are on an AS protocol.
Sponsors
Princess Alexandra Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. 40 to 75 years of age, with a life expectancy of at least 10 years with pathologically diagnosed low risk prostate cancer deemed suitable for active surveillance (based on NICE criteria) or definitive therapy of curative intent 2. History of previous prostate biopsy diagnosing low risk prostate cancer no sooner than 6 weeks prior. 3. No known problems with peripheral intravenous or central line access 4. Able to provide informed signed consent
Exclusion criteria
1. Age under 40 or greater than 75 years 2. Unable to lie flat during or unable to tolerate PET/MRI 3. Contraindication to PET scan or [68Ga]gallium-labelled PSMA ligand 4. Claustrophobia not manageable by oral sedatives ie Temazepam 5. Renal impairment (eGFR less than 30) 6. Contraindication to confirmatory prostate biopsy of identified lesions under general anaesthetic 7. Not suitable for definitive therapy of curative intent
Outcome results
None listed