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Brief Title: Biomarker-driven Intermittent Docetaxel Versus Standard-of-care (SOC) Docetaxel in Metastatic Castration-resistant Prostate Cancer
Official Title: A Randomised Non-comparative Phase II Trial of Biomarker-driven Intermittent Docetaxel Versus Standard-of-care (SOC) Docetaxel in Metastatic Castration-resistant Prostate Cancer (mCRPC)
Study ID: NCT04918810
Brief Summary: The purpose of this study is to see if a prostate cancer marker in the blood (mGSTP1) can be used to guide chemotherapy treatment. Based on the level of this blood marker, some men 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 men 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Border Medical Oncology Research Unit / The Border Cancer Hospital, Albury, New South Wales, Australia
Chris O'Brien Lifehouse, Camperdown, New South Wales, Australia
St Vincent's Hospital, Darlinghurst, New South Wales, Australia
Dubbo Base Hospital, Dubbo, New South Wales, Australia
Concord Repatriation General Hospital, Sydney, New South Wales, Australia
Frankston Hospital-Peninsula Health, Frankston, Victoria, Australia
Goulburn Valley Health, Shepparton, Victoria, Australia
LaTrobe Regional Hospital, Traralgon, Victoria, Australia
Name: Kate Mahon
Affiliation: Chris Obrien Lifehouse
Role: PRINCIPAL_INVESTIGATOR