Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Prostatic Neoplasms, Castration-Resistant

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Antineoplastic Agents

All Drugs and Chemicals

Docetaxel

Tubulin Modulators

Antimitotic Agents

suspend docetaxel prior to cycle 4, recommencement based on mGSTP1 monitoring

Docetaxel administered as per Standard of Care: as per clinician recommendation

After 3 cycles of docetaxel chemotherapy (75mg/m\^2 every 21) in combination with an undetectable mGSTP1 level, patients randomised to this arm will stop docetaxel treatment. Plasma mGSTP1 is measured every 21 days and docetaxel treatment will be recommenced if it mGSTP1 becomes detectable again.

Docetaxel intermittent

After 3 cycles of docetaxel chemotherapy (75mg/m\^2 every 21) in combination with an undetectable mGSTP1 level, patients randomised to this arm will continue with standard Docetaxel treatment (75mg/m\^2 every 21)

Docetaxel standard of care

Ronan Burder

Margaret McJannett

Craig Underhill

Jacqui McBurnie

Jacquie Harvey

Kate Mahon

Robert Kent

Megan Crumbaker

Florian Honeyball

Alicia Bell

Karen Ji

Martin Stockler

Jade Rice

Sanjeev Seewak

Javier Torres

Carole Mott

Jhodie Duncan

Hieu Chau

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.

Parallel Assignment randomised non-comparative

Biomarker-driven Intermittent Docetaxel Versus Standard-of-care (SOC) Docetaxel in Metastatic Castration-resistant Prostate Cancer

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)

Radiographic progression free survival (rPFS) is defined as the time from randomisation (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.

Time on treatment holidays is defined as the total length of time patients on the intermittent docetaxel arm spend off docetaxel within the treatment period i.e. prior to permanent treatment discontinuation

Incidence and severity of adverse events (AEs) using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.

Overall survival is defined as the time from randomisation to the date of death due to any cause

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, 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 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 using the patient reported modified PRO-CTCAE instrument

To compare resource use associated with mGSTP1 directed therapy per treatment group.

Will be measured from trial based eCRFs and will include frequency of mGSTP1 testing, use of docetaxel and corticosteroids, pathology tests and imaging.

Men 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)

To compare costs associated with treatment per treatment group. 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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Biomarker-driven Intermittent Docetaxel Versus Standard-of-care (SOC) Docetaxel in Metastatic Castration-resistant Prostate Cancer	NCT04918810	Castration Resi...	Docetaxel inter... Docetaxel stand...	18 Years -	Australian and New Zealand Urogenital and Prostate Cancer Trials Group
Biomarker-driven Intermittent Docetaxel Versus Standard-of-care (SOC) Docetaxel in Metastatic Castration-resistant Prostate Cancer	NCT04918810	Castration Resi...	Docetaxel inter... Docetaxel stand...	18 Years -	Australian and New Zealand Urogenital and Prostate Cancer Trials Group

Spots Global Cancer Trial Database for docetaxel intermittent