Prostate cancer Cancer Prostate Cancer
Conditions
Interventions
Current interventions as of 09/09/2021:
PSMA Imaging is a feasibility study looking at patients who have high-risk prostate cancer (in the absence of clinical evidence for distant meta
Sponsors
Public Health Scotland
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Current participant inclusion criteria as of 09/09/2021: 1. High-risk prostate cancer with no detectable distant metastasis using standard of care imaging (MRI prostate/pelvis, isotope bone scan, CT, non-PSMA PET/CT) undergoing radical prostatectomy and pelvic lymph node dissection 2. 68Ga-PSMA PET/CT done as part of the staging investigation 3. Histologically proven prostate cancer 4. No prior prostate cancer treatment including androgen deprivation therapy 5. Male aged =18 years 6. Considered suitable candidate for radical surgery for prostate cancer 7. Willingness to comply with scheduled visits Previous participant inclusion criteria: 1. High risk prostate cancer with no detectable metastasis using standard of care imaging (MRI prostate/pelvis, isotope bone scan, CT, non-PSMA PET/CT) undergoing radical prostatectomy and pelvic lymph node dissection 2. Histologically proven prostate cancer 3. No prior prostate cancer treatment including androgen deprivation therapy 4. Male aged 18 or over 5. Considered suitable candidate for radical surgery for prostate cancer 6. Adequate hepatic, bone marrow, coagulation and renal function as defined by the following criteria: 6.1. Haemoglobin > 9.0 g/dL 6.2. Platelets > 100 x 109 L 6.3. Creatinine <2 x ULN 6.4. Hepatic function: total bilirubin = 2 x ULN; ALT and AST = 3 x ULN 6.5. Prothrombin time = 1.5 x ULN; APTT = 1.5 x ULN 7. Willingness to comply with scheduled visits (including an additional PET/CT scan)
Exclusion criteria
Exclusion criteria: Current participant exclusion criteria as of 09/09/2021: 1. Evidence of demonstrable distant metastasis on standard of care imaging using combination of MRI, CT, isotopic bone scan, non-PSMA PET/CT, or PSMA-PET/CT where undertaken as standard of care 2. Patients not willing to receive surgical treatment with radical prostatectomy and pelvic node dissection 3. Patients who are unable or unwilling to give informed consent Previous participant exclusion criteria: 1. Evidence of demonstrable metastasis on standard of care imaging using combination of MRI, CT and isotopic bone scan 2. Patients not willing to receive surgical treatment with radical prostatectomy and pelvic node dissection 3. Patients not able to undergo PET/CT scan because of weight (e.g. >180 kg), claustrophobia, or not able to lie still during the scanning duration 4. Patients who already had PSMA PET/CT scan for diagnosis of prostate cancer 5. Patients who are unable or unwilling to give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 24/06/2019: 1. To establish whether prostate tumours with high PSMA expression have enhanced risk of pelvic nodal metastasis. 2. To establish best practice and optimise protocols for multi-centre application of PSMA PET/CT imaging. Previous primary outcome measure: 1. SUVmax is measured for each lesion using the 68Ga-PSMA PET/CT within 2 weeks of a scheduled RP and ePLND this will be used along with independent nuclear medicine physicians to determine the sensitivity, specificity, positive predictive and negative predictive values of 68Ga-THP-PSMA imaging in detecting pelvic nodal metastasis 2. The establishment of best practice will be measured by the production of protocols for multi-centre application of PSMA PET/CT imaging | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 24/06/2019: 1. To evaluate the feasibility of a future large scale randomised controlled trial (RCT), and develop quality assurance measures across the study team/network. 2. To develop a platform to carry out RCT to study the usefulness of novel imaging/biomarkers for evidence-based treatment decisions in patients at risk of pelvic nodal prostate cancer. Previous secondary outcome measures: 1. The use of novel 68Ga-THP-PSMA radiopharmaceutical is measured using the successful assessment of 60 patients through to the end of study and inclusion in the study analysis 2. Feasibility of a future large scale randomised controlled trial is measured using recruitment of 60 patients into the study within the proposed timelines and by the development of quality assurance measures across the study team/network 3. The development of a platform to carry out RCT to study the usefulness of novel imaging/biomarkers for evidence-based treatment decisions in patients at risk of pelvic nodal prostate cancer is measured by the future development of RCT’s in this area. | — |
Countries
England, Scotland, United Kingdom
Contacts
Public ContactKathleen Riddle
Outcome results
None listed