Brief Summary
The purpose of this study is to see if a prostatea walnut-shaped gland in the male reproductive system that is responsible for producing semen - a bodily fluid that acts as a vessel for sperm transport during ejaculation cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs marker in the bloodthe red bodily fluid that transports oxygen and other nutrients around the body (mGSTP1) can be used to guide chemotherapya cancer treatment that uses drugs to kill or slow the growth of cancer cells, while minimising damage to healthy cells treatment. Based on the level of this blood marker, some people may be able to have breaks in treatment rather than having chemotherapy continuously which is the current standard of care. This study will tell us if having these treatment breaks guided by mGSTP1 can improve how people feel during treatment while still treating the prostate cancer effectively.
Docetaxel is a chemotherapy drug that is approved to treat prostate cancer and has been used for many years to treat prostate cancer like yours. Your doctor has already discussed this with you and you have both agreed that docetaxel is the best treatment for you to have at this time. You will have already started this chemotherapeutic treatment with docetaxel.
Intervention / Treatment
- Drug: Docetaxel intermittent
Inclusion Criteria
PRESCREENING INCLUSION CRITERIA
- Patient has provided written informed consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment. using the GUIDE pre-screening PICF
- Age ≥ 18 years at the time of pre-screening consent
- Males with metastatic castration-resistant prostate cancer (as per PCWG3) AND are planned to commence docetaxel chemotherapy
- WHO Eastern Cooperative Oncologythe study, diagnosis and treatment of cancer Group (ECOG) performance status 0-2 (Appendix 1)
- Histological confirmation of prostate cancer
- Patients must have adequate bone marrowsoft, spongy tissue found in bones that makes blood cells 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)
- Plateletssmall disc-shaped blood cells that clump together to form clots to stop bleeding ≥ 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
- Willing and able to comply with all pre-screening study requirements, including blood teststesting done to measure the levels of certain substances in the blood for mGSTP1 analysis before and during docetaxel treatment
MAIN SCREENINGtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer screening INCLUSION CRITERIA
- Patient has provided written informed consent for the main GUIDE study PICF
- Patient has a detectable plasma mGSTP1 deoxyribonucleic acid (DNA) as measured by central laboratory at prescreening prior to commencing first cycle of docetaxel chemotherapy
- Patient has commenced 3 cycles of docetaxel
- Patient has undetectable plasma mGSTP1 DNA as measured by central laboratory from blood taken prior to the third cycle of docetaxel
- Patient is willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments.