None listed
Conditions
Brief summary
A multicentre clinical trial evaluating the additive value of a novel diagnostic test (Prostate Specific Membrane Antigen Positron Emission Tomography (PSMA PET)) in addition to and in combination with the current gold-standard reference in men undergoing 12-month confirmatory biopsy during Active Surveillance for low- or intermediate-risk prostate cancer Who is it for? You may be eligible to join this study if you are aged 18 and above, have been newly diagnosed prostate cancer deemed suitable for active surveillance by treating urologist and not yet had a 12-month confirmatory biopsy on active surveillance Study details All participants in this study will undergo a limited (pelvic only) 68Ga-PSMA PET/CT in addition to their standard-of-care surveillance mpMRI within 3 months prior to their 12-month (range 6-18-months) confirmatory biopsy. The diagnostic accuracy of PSMA PET will be compared to the current gold-standard reference test of mpMRI and saturation transperineal confirmatory biopsy. Although recent studies have demonstrated the value of mpMRI as a surveillance tool, it has a propensity to miss a small proportion of clinically significant PCa which has limited its ability to safely replace surveillance biopsies. To date, the additive value of PSMA PET in AS has not been evaluated. Given its promising performance in the detection of both metastatic PCa in a BCR setting and the primary diagnosis of intraprostatic PCa, we propose the evaluation of its use in AS.
Interventions
All patients newly enrolled onto Active Surveillance program will undergo a limited (pelvic only) 68Ga-PSMA PET/CT in addition to their standard-of-care surveillance mpMRI within 3 months prior to their 12-month (range 6-18-months) confirmatory biopsy.
68Ga-PSMA (HBED CC-11), will be produced on-site compliant to the Good Laboratory Practices procedure. Radio-pharmacy quality control will be undertaken using a high-pressure liquid chromatography (HPLC). 68Ga-PSMA (HBED CC-11) 1.8-2.2MBq/kg, su
All patients newly enrolled onto Active Surveillance program will undergo a limited (pelvic only) 68Ga-PSMA PET/CT in addition to their standard-of-care surveillance mpMRI within 3 months prior to their 12-month (range 6-18-months) confirmatory biopsy. 68Ga-PSMA (HBED CC-11), will be produced on-site compliant to the Good Laboratory Practices procedure. Radio-pharmacy quality control will be undertaken using a high-pressure liquid chromatography (HPLC). 68Ga-PSMA (HBED CC-11) 1.8-2.2MBq/kg, subject to variation in yield from Ge-68/Ga-68 generator will be administered. A limited field of view PSMA PET of the pelvis (minimum of 3 minutes/bed stop) will be undertaken around 60 minutes (+/- 10 minutes) post injection with a non-contrast-enhanced CT scan (pelvis) performed around 60 minutes (+/- 10 minutes) post tracer injection.
Sponsors
St. Vincent's Prostate Cancer Research Centre
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1 18 years or greater of age 2 Life expectancy of 10 years or greater 3 Newly diagnosed PCa deemed suitable for AS by treating urologist and not yet had a 12-month confirmatory biopsy on AS 4 A diagnosis of PCa meeting the following histopathological criteria: o Organ-confined PCa: cT1-2a, cN0 and/or cM0/x o ISUP Grade Group 2 PCa with < 20% Gleason pattern 4 overall and in each location; or o ISUP Grade Group 1 PCa with ANY of the following high-risk features: > 30% maximum cancer core involvement of any single core; or > 6 mm cancer in any core; or > 4 locations with cancer on biopsy; or PI-RADS V2.1 4 or 5 lesion on baseline mpMRI Focus on PSMA PET suspicious for PCa (SUVmax > 4 in PZ or > 5 in TZ) 5 No evidence of intraductal or cribriform architecture or EPE 6 No previous PCa treatment 7 Able to provide written informed consent to and willing to remain on AS 8 Planned for confirmatory biopsy within next 12 months following enrolment onto the study 9 Able to give written informed consent to, willing to participate and comply with the study
Exclusion criteria
• Inability/incapacity to provide written informed consent to either AS or study • Unwilling to remain on AS for the duration of study • Has a diagnosis of PCa deemed not suitable for AS and treating urologist/not meeting ideal histological criteria • Has had prior treatment for PCa • Has had a prior normal or non-suspicious PSMA PET within 2 years of confirmatory biopsy • Has a contraindication to mpMRI or PSMA PET
Outcome results
None listed