Biomarker-driven Intermittent Docetaxel in Metastatic Castration-resistant Prostate Cancer

NCT04918810 | Terminated Phase 2 DMC

• 1 other identifier: ANZUP 1903
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 8

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.

Conditions

Castration Resistant Prostatic Cancer

Keywords

mGSTPi

Outcome Measures

Primary Outcomes (1)

• Radiographic progression free survival (rPFS)

  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.

  From enrollment until last patient has completed 2 years in follow up, on average 3.5 years

Secondary Outcomes (9)

• Time on treatment holidays

  From enrollment until last patient has completed 2 years in follow up, on average 3.5 years

• 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

• Overall survival

  From enrollment until last patient has completed 2 years in follow up, on average 3.5 years

• Overall quality of life

  From enrollment until last patient has completed 2 years in follow up, on average 3.5 years

• Fatigue

  From enrollment until last patient has completed 2 years in follow up, on average 3.5 years

Study Arms (1)

Arm 1: Intermittent docetaxel treatment

EXPERIMENTAL

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

Drug: Docetaxel intermittent

Interventions

Docetaxel intermittent DRUG

After 3 or 4 cycles of docetaxel chemotherapy (75mg/m\^2 every 21 days or 50mg/m\^2 every 14 days) in combination with an undetectable mGSTP1 level, patients will stop docetaxel treatment. Plasma mGSTP1 is measured every 21 days or 28 days (depending on Docetaxel regimen) and docetaxel treatment will be recommenced if it mGSTP1 becomes detectable again.

Arm 1: Intermittent docetaxel treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Australian and New Zealand Urogenital and Prostate Cancer Trials Group: lead
• Peter MacCallum Cancer Centre, Australia: collaborator

Study Sites (8)

Border Medical Oncology Research Unit / The Border Cancer Hospital

Albury, New South Wales, 2460, Australia

Location

Chris O'Brien Lifehouse

Camperdown, New South Wales, 2050, Australia

Location

St Vincent's Hospital

Darlinghurst, New South Wales, 2021, Australia

Location

Dubbo Base Hospital

Dubbo, New South Wales, 2830, Australia

Location

Concord Repatriation General Hospital

Sydney, New South Wales, Australia

Location

Frankston Hospital-Peninsula Health

Frankston, Victoria, 3199, Australia

Location

Goulburn Valley Health

Shepparton, Victoria, 3630, Australia

Location

LaTrobe Regional Hospital

Traralgon, Victoria, 3844, Australia

Location

Related Links

• ANZUP website

MeSH Terms

Conditions

Prostatic Neoplasms, Castration-Resistant

Condition Hierarchy (Ancestors)

Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Kate Mahon

  Chris Obrien Lifehouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2021
• First Posted: June 9, 2021
• Study Start: July 29, 2022
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (8)