Phase II Study of the Use of Neoadjuvant Cabazitaxel With Hormonal Treatment in Patients Operable Prostate Cancer, Assess the Efficacy and Toxicity of Cabazitaxel, and Explore Potential Predictive and Prognostic Markers of Clinical Outcome

Launched by THE CLATTERBRIDGE CANCER CENTRE NHS FOUNDATION TRUST · Nov 4, 2020

Keywords

ClinConnect Summary

This clinical trial is investigating the use of cabazitaxel, a type of chemotherapy, in combination with hormonal treatment prior to surgery for patients with operable prostate cancer that is considered high-risk for returning after surgery. The goal is to see how effective this treatment is and to understand any potential side effects. Researchers are also looking for certain markers that might help predict how well patients respond to the treatment.

To be eligible for this trial, participants must be at least 18 years old and have been diagnosed with high-risk prostate cancer, which may include specific tumor sizes or levels of a protein called PSA. They must also be suitable candidates for surgery and have good overall health. Participants will undergo treatment and regular check-ups to monitor their health throughout the study. It's important to note that the trial is not currently recruiting participants, so there may be a waiting period before anyone can join.

Gender

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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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