None listed
Conditions
Brief summary
This is a proof of concept study with the purpose of examining the anti-tumour immune response after local irreversible electroporation (IRE) in patients with prostate cancer. Who is it for? You may be eligible for this study if you are male, aged 18 years or over, have prostate cancer, and scheduled for either IRE or radical prostatectomy. Study details There will be two groups of participants: patients scheduled for IRE, and patients scheduled for radical prostatectomy. Both groups of participants will undergo their scheduled treatment as usual. In addition, both groups will have blood samples collected before treatment, and on days 3, 14 and 30 after treatment. It is hoped that this research will improve understanding of systemic anti-tumour immune response after IRE, and thus offer insight for future cancer treatment strategies.
Interventions
This project is a single-centre proof of concept study conducted at St Vincent’s Private Hospital, Sydney (Patient recruitment and treatment centre). Patients that are planned for focal irreversible electroporation (IRE) also known as NanoKnife procedure will undergo venous blood collection prior to treatment (baseline) and 3, 14 and 30 days post IRE. The immunological response following IRE will be compared to patients that are treated by radical prostatectomy and have had blood collected at th
This project is a single-centre proof of concept study conducted at St Vincent’s Private Hospital, Sydney (Patient recruitment and treatment centre). Patients that are planned for focal irreversible electroporation (IRE) also known as NanoKnife procedure will undergo venous blood collection prior to treatment (baseline) and 3, 14 and 30 days post IRE. The immunological response following IRE will be compared to patients that are treated by radical prostatectomy and have had blood collected at the same time points, to assess whether there is an ongoing systemic anti-tumour response. Blood tests will only be used for the purpose of the study analysis and will not affect patient treatment
Sponsors
St. Vincent's Private Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients must meet the following inclusion criteria to be eligible to participate in the study • Male, aged 18 years or over • Confirmed adenocarcinoma of prostate with organ confined (less than or equal to cT2) disease and Gleason 3 + 4 = 7 or Gleason 4 + 3 = 7 prostate cancer. • Currently scheduled for either IRE or radical prostatectomy • No previously diagnosed prostate cancer • No use of immunosuppressive drugs • Ability to give written informed consent, participate in and comply with study • Able to attend blood collection centre at appropriate time.
Exclusion criteria
Patients who meet any of the following exclusion criteria are not eligible to participate in the study • Use of immunosuppressive drugs • Previous diagnosis of prostate cancer • Inability/ incapacity to provide own consent • Inability/ incapacity for venous blood collection • PSA >20ng/ml • greater than or equal to cT3 on DRE
Outcome results
None listed