Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-25 @ 3:47 AM
NCT ID:
NCT04097002
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04097002
Study Brief:
Protocol Section:
NCT04097002