Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of Oxford
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
Males aged 18 years and older
Histologically confirmed prostate cancer diagnosed on biopsy within 6 months
Clinically localised, low or intermediate risk prostate cancer, i.e.:
* Gleason score ≤ 7
* Local tumour stage ≤T2c
* No evidence of metastases (Nx/N0 and Mx/M0)
* PSA ≤ 20 ng/ml
Scheduled for and considered fit for radical prostatectomy
Absence of any indication to perform urgent surgery that would not allow administration of the vaccine during the 12 week period prior to radical prostatectomy
No invasive treatment for prostatic disease within the last 2 years
Subject is free of clinically apparent/active autoimmune disease (no prior confirmed diagnosis or treatment for autoimmune disease including Systemic Lupus Erythematosis, Grave's Disease, Hashimoto's Thyroiditis, Multiple Sclerosis, and Insulin Dependent Diabetes Mellitus). Note subjects with Non-Insulin Dependent Diabetes Mellitus can be included.
Subject has adequate bone marrow function as defined by an Absolute Lymphocyte Count (ALC) ≥ 500/µL, Absolute Neutrophil Count (ANC) \>1200/µL, Platelet Count \>100,000/µL.
Subject must practice a reliable form of contraception (barrier or vasectomy) while they are being treated with vaccines and another effective method of birth control must also be used by their partner
Males aged 18 and older
Histologically confirmed prostate cancer diagnosed on biopsy within 6 months
Clinically localised, low or intermediate risk prostate cancer, i.e.:
* Gleason score ≤ 7
* Local tumour stage ≤T2c
* No evidence of metastases (Nx/N0 and Mx/M0)
* PSA ≤ 20 ng/ml
Stable disease on Active Surveillance for a minimum of 12 months previously
Suitable to remain on Active Surveillance at time of last clinical assessment
No invasive treatment for prostatic disease within the last 2 years
Subject is free of clinically apparent/active autoimmune disease (no prior confirmed diagnosis or treatment for autoimmune disease including Systemic Lupus Erythematosis, Grave's Disease, Hashimoto's Thyroiditis, Multiple Sclerosis, and Insulin Dependent Diabetes Mellitus). Note subjects with Non-Insulin Dependent Diabetes Mellitus can be included.
Subject has adequate bone marrow function as defined by an Absolute Lymphocyte Count (ALC) ≥ 500/µL, Absolute Neutrophil Count (ANC) \>1200/µL, Platelet Count \>100,000/µL.
Subject must practice a reliable form of contraception (barrier or vasectomy) while they are being treated with vaccines and another effective method of birth control must also be used by their partner
You may not be if
Diagnosis of any cancer other than prostate cancer within the last 5 years (except basal cell carcinoma)
Any suspicion of metastatic cancer
Any Gleason grade 5 component in the prostatic biopsies
Participation in another research study involving an investigational product in the 30 days preceding enrolment, or planned use during the study period
Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate
Seropositive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) or HIV
Any confirmed or suspected immunosuppressive or immunodeficient state, asplenia, recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled/topical steroids are allowed)
