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:
2025-12-24 @ 12:32 PM
Ignite Modification Date:
2025-12-24 @ 12:32 PM
NCT ID:
NCT04622761
Eligibility Criteria:
Inclusion Criteria:
1. Aged ≥18 years
2. ECOG performance status 0-1 (Appendix 2)
3. Diagnosis of high risk prostate cancer as defined by one or more of the following: clinically T2c/T3, Gleason 8-10 and or PSA \>10ng/ml
4. Appropriate candidate for radical prostatectomy
5. Life expectancy greater than 10 years
6. Adequate organ function as evidenced by peripheral blood counts and serum chemistries at enrolment
7. Ability and capacity to consent and comply with study and follow-up procedures
8. Fit to receive chemotherapy
Exclusion Criteria:
1. Locally advanced or metastatic disease
2. Patients with a history of other previous malignancy except treated CIN or non melanomatous skin cancer
3. Grade ≥2 peripheral neuropathy
4. Grade ≥2 stomatitis
5. History of severe hypersensitivity reaction (≥ grade 3) to taxane
6. History of severe hypersensitivity reaction (≥ grade 3) to polysorbate 80 containing drugs
7. Other concurrent serious illness or medical conditions
8. Inadequate organ and bone marrow function as evidenced by:
1. Haemoglobin \<10.0 g/dL
2. Absolute neutrophil count \<1.5 x 109/L
3. Platelet count \<100 x 109/L
4. AST/SGOT and/or ALT/SGPT \>1.5 xULN
5. Total bilirubin \>1.5 x ULN
6. Serum creatinine \>1.5 x ULN (if creatinine is 1.0 - 1.5 xULN, creatinine clearance will be calculated according to CKD-EPI formula and patients with creatinine clearance \<60mL/min should be excluded - see Appendix 3)
9. Uncontrolled diabetes mellitus
10. Active uncontrolled gastro oesophageal reflux disease (GORD)
11. Active infection requiring systemic antibiotic or antifungal medication
12. Participation in another clinical trial with any investigational drug within 30 days prior to study enrolment
13. Concurrent or planned treatment with strong inhibitors of cytochrome P450 3A4/5 (a 1-week washout period is necessary for patients who are already on these treatments - see Appendix 5 for a list of CYP3A inhibitors)
14. Concurrent or planned treatment with strong inducers of cytochrome P450 3A4/5 (a 1-week washout period is necessary for patients who are already on these treatments) - see Appendix 4 for a list of CYP3A inducers)
15. Contraindications or sensitivity to GCSF treatments
16. History of myocardial infarction, unstable symptomatic ischemic heart disease, ongoing arrhythmias of Grade \> 2 (NCI CTCAE, version 4.03), thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events), or any other cardiac condition (e.g., pericardial effusion restrictive cardiomyopathy) within 6 months prior to first dose of study drug. Chronic stable atrial fibrillation on stable anticoagulant therapy is allowed.
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Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04622761
Study Brief:
Protocol Section:
NCT04622761