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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04918810
Ethics application status
Date submitted
26/05/2021
Date registered
9/06/2021

Titles & IDs
Public title
Biomarker-driven Intermittent Docetaxel in Metastatic Castration-resistant Prostate Cancer
Scientific title
A Phase II Trial of Biomarker-driven Intermittent 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

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


Treatment: Drugs: Docetaxel intermittent
After 3 cycles of docetaxel chemotherapy (75mg/m\^2 every 21) in combination with an undetectable mGSTP1 level, patients will stop docetaxel treatment. Plasma mGSTP1 is measured every 21 days and docetaxel treatment will be recommenced if it mGSTP1 becomes detectable again.
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 enrollment 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 enrollment 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 enrollment 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 enrollment 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 enrollment 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 enrollment 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 enrollment 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
NA
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
Single group
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
30/12/2026
Actual
Sample size
Target
28
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
Trial website
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
Antoinette Fontela
Address 0 0
Country 0 0
Phone 0 0
02 9562 5033
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04918810