Eligibility Details:
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