Biomarker-driven Intermittent Docetaxel in Metastatic Castration-resistant Prostate Cancer
- Conditions
- Castration Resistant Prostatic Cancer
- Interventions
- Registration Number
- NCT04918810
- Lead Sponsor
- Australian and New Zealand Urogenital and Prostate Cancer Trials Group
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Male
- Target Recruitment
- 6
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Arm 1: Intermittent docetaxel treatment Docetaxel intermittent suspend docetaxel prior to cycle 4, recommencement based on mGSTP1 monitoring
- Primary Outcome Measures
Name Time Method Radiographic progression free survival (rPFS) From enrollment until last patient has completed 2 years in follow up, on average 3.5 years Radiographic progression free survival (rPFS) is defined as the time from enrollment (i.e. prior to cycle 4), the date of first documented progression on imaging by site investigator (PCWG3 criteria for bone lesions and RECIST 1.1 for soft tissue lesions) or death due to any cause.
- Secondary Outcome Measures
Name Time Method Time on treatment holidays From enrollment until last patient has completed 2 years in follow up, on average 3.5 years Time on treatment holidays is defined as the total length of time patients on the intermittent docetaxel spend off docetaxel within the treatment period i.e. prior to permanent treatment discontinuation
Frequency of health resource utilisation From time of consent until End of Study, on average 3.5 years To compare resource use associated with mGSTP1 directed therapy. Will be measured from trial based eCRFs and will include frequency of mGSTP1 testing, use of docetaxel and corticosteroids, pathology tests and imaging.
People participating in the GUIDE study will be consented for access to their Medicare claims data providing information on outpatient use of PBS listed therapies (such as those for metastatic bone disease) and Medicare services (such as outpatient clinician services)Overall treatment safety From the date of signing consent on the Main study until 90 days after the last day of protocol treatment, on average 3.5 years Incidence and severity of adverse events (AEs) using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.
Overall survival From enrollment until last patient has completed 2 years in follow up, on average 3.5 years Overall survival is defined as the time from enrollment to the date of death due to any cause
Overall quality of life From enrollment until last patient has completed 2 years in follow up, on average 3.5 years Quality of Life using the EORTC QLQ-C30 (European Organisation for Research on Treatment of Cancer - Quality of Life Questionnaire for cancer patients) instrument.
The instrument uses 28 questions about overall quality of life with each question answerable using a scale from 1 (not at all) to 4 (very much). Overall scores can be from a minimum of 28 indicating a better quality of life and higher scores with a maximum of 112 indicating lower overall quality of life.
The questionnaire also has two summary questions which asks participants to rank 1) overall health and 2) overall quality of life on scale of from 1, very poor, to 7, excellent.Fatigue From enrollment until last patient has completed 2 years in follow up, on average 3.5 years Fatigue, using the EORTC FA-12 (European Organisation for Research on Treatment of Cancer - Fatigue) instrument.
This instrument uses 12 questions for participants about fatigue with each question answerable on a scale of 1 (not at all) to 4 (Very Much) to a maximum score of 48 indicating worse overall self-rated fatigue.Fear of progression From enrollment until last patient has completed 2 years in follow up, on average 3.5 years Fear of progression using the short FOP12 (Fear of Progression) instrument.
This instrument uses 12 questions about participant's own Fear of Progression with each question answerable using a scale from "Never" to "very often" with lower scores indicating a better outcome.Patient reported adverse events From enrollment until last patient has completed 2 years in follow up, on average 3.5 years Patient reported adverse events using the patient reported modified PRO-CTCAE instrument
Overall cost associated with treatment From time of consent until End of Study, on average 3.5 years To compare costs associated with treatment. Will be reported by type of health care used and the total cost of health care used over the period of the trial and follow-up.
Market prices will be applied to items of resource use to estimate costs.
Trial Locations
- Locations (8)
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