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RecruitingLast updated: 16 January 2024

GUIDE: This Phase II trial is trying to understand how effective chemotherapy (docetaxel) is when delivered intermittently, compared to continuously, in men with metastatic castration-resistant prostate cancerA Randomised Non-comparative Phase II Trial of Biomarker-driven Intermittent Docetaxel Versus Standard-of-care (SOC) Docetaxel in Metastatic Castration-resistant Prostate Cancer (mCRPC)

Clinical summary

Summary

This is a randomised trial that is assessing whether docetaxel can be effectively delivered intermittently, based on a prostate cancer marker in the blood (mGSTP1), rather than continuously which is the current standard of care.

In the Experimental Arm, participants will receive 3 cycles of docetaxel chemotherapy (75mg/m^2 every 21 days) in combination with undetectable mGSTP1 level and then will stop docetaxel treatment. Plasma mGSTP1 is measured every 21 days and docetaxel treatment will be recommenced if mGSTP1 becomes detectable again.

In the Active Comparator Arm, participants will receive the standard of care docetaxel treatment of continuous docetaxel treatment.

Conditions

This trial is treating patients with prostate cancer

Cancer

Urinary System Cancers Genitourinary

Age

People18+

Phase

II

Trial Acronym

GUIDE

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Peter MacCallum Cancer Centre,Australian & New Zealand Urogenital and Prostate Cancer Trials Group Limited (ANZUP)

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)

Eligibility

Inclusion

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

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.

 

Exclusion

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 EXCLUSION 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

Inclusion

  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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