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

NCT04918810 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2024-11-22

No results posted yet for this study

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

Interventions

DRUG

Docetaxel intermittent

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.

Sponsors & Collaborators

  • Peter MacCallum Cancer Centre, Australia

    collaborator OTHER

  • Australian and New Zealand Urogenital and Prostate Cancer Trials Group

    lead OTHER

Principal Investigators

  • Kate Mahon · Chris Obrien Lifehouse

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-29
Primary Completion
2024-11-01
Completion
2024-11-01

Countries

  • Australia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04918810 on ClinicalTrials.gov