First in Man Clinical Study to Evaluate Safety and Tolerability of an Oncolytic Adenovirus in Prostate Cancer Patients.

Inclusion Criteria: 1. Histologically confirmed adenocarcinoma of the prostate, which is localized to the prostate ( within 24 months of screening) 2. Absence of lymph node, bone or other metastases as determined by MRI and CT scan, Bone Scan or nano-MRI (≤3 months prior to first administration) 3. Men between 18 and 75 years inclusive 4. ECOG status 0 or 1 5. Ability to understand and willingness to sign informed consent 6. Adequate liver, renal and bone marrow function: AST \& ALT \< 2.5 x ULN, total bilirubin \< 1.5 x ULN, Alkaline phosphatase \< 3 x ULN, Serum creatinine \< 1.5 x ULN, Haemoglobin \> 9.0 g/dL (5.59 mmol/L), Platelet count \> 100x10\*9/L, Neutrophils \> 1.5x10\*9/L, INR \< 1.5xULN 7. eGFR ≥ 30 mL/min, using the Cockcroft - Gault Equation: Creatinine Clearance = \[{(140 - age in years) x (weight in kg)} x 1.23\] /serum Creatinine in Mmol/L Exclusion Criteria: 1. Tumor not accessible for injection 2. Prior treatment of prostate cancer with radiation therapy or brachytherapy 3. Prior use of chemotherapy/hormone therapy for treatment of cancer 4. Target tumor adherent to a major vascular structure 5. Participation in any investigational drug study within the last 12 months prior to first administration of ORCA-010 6. Clinically significant active infection (viral or bacterial) 7. Known immunosuppressive diseases (e.g. HIV, Hepatitis B and C) 8. History of any other oncological malignancy, excluding basal cell carcinoma of the skin, in the past 5 years 9. Not willing to refrain from sexual activities or use a double barrier contraceptive device (condom with foam or vaginal suppository, diaphragm with spermicide) after administration of ORCA-010 and until 42 days after the last ORCA-010 administration 10. Severe obesity defined as Body Mass Index (BMI) \> 30 kg/m2 11. Positive for adenovirus in throat swap or serum as determined by PCR at screening 12. Recent (within 3 months prior to enrolment in the study) history of alcohol abuse or other substances such as barbiturates, cannabinoids and amphetamines or a positive urine screen for drugs of abuse 13. Use of medication known to have immunosuppressive effects, except topical/inhaled steroids under 10 mg/day prednisolone equivalent (See Appendix 7) 14. Use of systemic antiviral medication within 3 months prior to enrolment in the study 15. Use of any anti-coagulants/blood thinner except for ASA 81mg 16. Any condition that in the opinion of the Investigator could interfere with the conduct of the study 17. For Part B only: Subjects enrolled in Part A of the study