Biomarker-driven Intermittent Docetaxel in Metastatic Castration-resistant Prostate Cancer

Inclusion Criteria

• •1. Patient has provided written informed consent using the GUIDE pre-screening PICF
• •2. Age ≥ 18 years at the time of pre-screening consent
• •3. Males with metastatic castration-resistant prostate cancer (as per PCWG3) AND are planned to commence docetaxel chemotherapy
• •4. WHO Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Appendix 1)
• •5. Histological confirmation of prostate cancer
• •6. Patients must have adequate bone marrow and hepatic function within 14 days prior Cycle 1 day 1:
• •* Haemoglobin ≥ 90 g/L independent of transfusions (no red blood cell transfusion in last 4 weeks)
• •* Platelets ≥ 100 x 109/L
• •* Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
• •* Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN)
• •* Alanine aminotransferase (ALT)/Aspartate aminotransferase (AST) ≤ 2.5 x ULN
• •7. Willing and able to comply with all pre-screening study requirements, including blood tests for mGSTP1 analysis before and during docetaxel treatment
• •1. Patient has provided written informed consent for the main GUIDE study PICF
• •2. Patient has a detectable plasma mGSTP1 deoxyribonucleic acid (DNA) as measured by central laboratory at prescreening prior to commencing first cycle of docetaxel chemotherapy
• •3. Patient has commenced 3 cycles of docetaxel
• •4. Patient has undetectable plasma mGSTP1 DNA as measured by central laboratory from blood taken prior to the third cycle of docetaxel
• •5. Patient is willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments.
• •MAIN SCREENING EXCCLUSION CRITERIA
• •1. Known hypersensitivity to docetaxel or its excipients
• •2. Concurrent illness, including severe infection that may jeopardise the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety
• •3. Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol
• •4. Progressive disease by RECIST 1.1 within the first 3 cycles of docetaxel