Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04918810




Registration number
NCT04918810
Ethics application status
Date submitted
26/05/2021
Date registered
9/06/2021
Date last updated
29/03/2023

Titles & IDs
Public title
Biomarker-driven Intermittent Docetaxel Versus Standard-of-care (SOC) Docetaxel in Metastatic Castration-resistant Prostate Cancer
Scientific 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)
Secondary ID [1] 0 0
ANZUP 1903
Universal Trial Number (UTN)
Trial acronym
GUIDE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Castration Resistant Prostatic Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Docetaxel intermittent
Treatment: Drugs - Docetaxel standard of care

Experimental: Arm 1: Intermittent docetaxel treatment - suspend docetaxel prior to cycle 4, recommencement based on mGSTP1 monitoring

Active Comparator: Arm 2: Standard of Care docetaxel treatment - Docetaxel administered as per Standard of Care: as per clinician recommendation


Treatment: Drugs: 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 stop docetaxel treatment. Plasma mGSTP1 is measured every 21 days and docetaxel treatment will be recommenced if it mGSTP1 becomes detectable again.

Treatment: Drugs: Docetaxel standard of care
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)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Radiographic progression free survival (rPFS)
Timepoint [1] 0 0
From randomisation until last patient has completed 2 years in follow up, on average 3.5 years
Secondary outcome [1] 0 0
Time on treatment holidays
Timepoint [1] 0 0
From randomisation until last patient has completed 2 years in follow up, on average 3.5 years
Secondary outcome [2] 0 0
Overall treatment safety
Timepoint [2] 0 0
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
Secondary outcome [3] 0 0
Overall survival
Timepoint [3] 0 0
From randomisation until last patient has completed 2 years in follow up, on average 3.5 years
Secondary outcome [4] 0 0
Overall quality of life
Timepoint [4] 0 0
From randomisation until last patient has completed 2 years in follow up, on average 3.5 years
Secondary outcome [5] 0 0
Fatigue
Timepoint [5] 0 0
From randomisation until last patient has completed 2 years in follow up, on average 3.5 years
Secondary outcome [6] 0 0
Fear of progression
Timepoint [6] 0 0
From randomisation until last patient has completed 2 years in follow up, on average 3.5 years
Secondary outcome [7] 0 0
Patient reported adverse events
Timepoint [7] 0 0
From randomisation until last patient has completed 2 years in follow up, on average 3.5 years
Secondary outcome [8] 0 0
Frequency of health resource utilisation
Timepoint [8] 0 0
From time of consent until End of Study, on average 3.5 years
Secondary outcome [9] 0 0
Overall cost associated with treatment
Timepoint [9] 0 0
From time of consent until End of Study, on average 3.5 years

Eligibility
Key inclusion criteria
PRESCREENING 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

PRESCREENING EXCLUSION CRITERIA

1. Prior docetaxel or cabazitaxel chemotherapy for castration-resistant prostate cancer

2. Prior docetaxel in the castration sensitive prostate cancer setting within the
previous 2 years

3. Known hypersensitivity to docetaxel or its excipients

4. Concurrent illness, including severe infection that may jeopardise the ability of the
patient to undergo the procedures outlined in this protocol with reasonable safety

5. Serious medical or psychiatric conditions that might limit the ability of the patient
to comply with the protocol

MAIN SCREENING INCLUSION CRITERIA

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
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/11/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2026
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Border Medical Oncology Research Unit / The Border Cancer Hospital - Albury
Recruitment hospital [2] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment hospital [3] 0 0
St Vincent's Hospital - Darlinghurst
Recruitment hospital [4] 0 0
Dubbo Base Hospital - Dubbo
Recruitment hospital [5] 0 0
Concord Repatriation General Hospital - Sydney
Recruitment hospital [6] 0 0
Frankston Hospital-Peninsula Health - Frankston
Recruitment hospital [7] 0 0
Goulburn Valley Health - Shepparton
Recruitment hospital [8] 0 0
LaTrobe Regional Hospital - Traralgon
Recruitment postcode(s) [1] 0 0
2460 - Albury
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
2021 - Darlinghurst
Recruitment postcode(s) [4] 0 0
2830 - Dubbo
Recruitment postcode(s) [5] 0 0
- Sydney
Recruitment postcode(s) [6] 0 0
3199 - Frankston
Recruitment postcode(s) [7] 0 0
3630 - Shepparton
Recruitment postcode(s) [8] 0 0
3844 - Traralgon

Funding & Sponsors
Primary sponsor type
Other
Name
Australian and New Zealand Urogenital and Prostate Cancer Trials Group
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Peter MacCallum Cancer Centre, Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04918810
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kate Mahon
Address 0 0
Chris Obrien Lifehouse
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Ronan Burder
Address 0 0
Country 0 0
Phone 0 0
03 8559 5088
Fax 0 0
Email 0 0
ronan.burder@petermac.org
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04918810