Status:
TERMINATED
Biomarker-driven Intermittent Docetaxel in Metastatic Castration-resistant Prostate Cancer
Lead Sponsor:
Australian and New Zealand Urogenital and Prostate Cancer Trials Group
Collaborating Sponsors:
Peter MacCallum Cancer Centre, Australia
Conditions:
Castration Resistant Prostatic Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
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 h...
Eligibility Criteria
Inclusion
- PRESCREENING INCLUSION CRITERIA
- Patient has provided written informed consent using the GUIDE pre-screening PICF
- Age ≥ 18 years at the time of pre-screening consent
- Males with metastatic castration-resistant prostate cancer (as per PCWG3) AND are planned to commence docetaxel chemotherapy
- WHO Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (Appendix 1)
- Histological confirmation of prostate cancer
- 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
- 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
- Prior docetaxel or cabazitaxel chemotherapy for castration-resistant prostate cancer
- Prior docetaxel in the castration sensitive prostate cancer setting within the previous 2 years
- Known hypersensitivity to docetaxel or its excipients
- Concurrent illness, including severe infection that may jeopardise the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety
- Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol
- MAIN SCREENING INCLUSION CRITERIA
- Patient has provided written informed consent for the main GUIDE study PICF
- Patient has a detectable plasma mGSTP1 deoxyribonucleic acid (DNA) as measured by central laboratory at prescreening prior to commencing first cycle of docetaxel chemotherapy
- Patient has commenced 3 cycles of docetaxel
- Patient has undetectable plasma mGSTP1 DNA as measured by central laboratory from blood taken prior to the third cycle of docetaxel
- Patient is willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments.
- MAIN SCREENING EXCCLUSION CRITERIA
- Known hypersensitivity to docetaxel or its excipients
- Concurrent illness, including severe infection that may jeopardise the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety
- Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol
- Progressive disease by RECIST 1.1 within the first 3 cycles of docetaxel
Exclusion
Key Trial Info
Start Date :
July 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2024
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04918810
Start Date
July 29 2022
End Date
November 1 2024
Last Update
November 22 2024
Active Locations (8)
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1
Border Medical Oncology Research Unit / The Border Cancer Hospital
Albury, New South Wales, Australia, 2460
2
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia, 2050
3
St Vincent's Hospital
Darlinghurst, New South Wales, Australia, 2021
4
Dubbo Base Hospital
Dubbo, New South Wales, Australia, 2830