NCT04918810

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

A Phase II Trial of Biomarker-driven Intermittent Docetaxel in Metastatic Castration-resistant Prostate Cancer (mCRPC)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Australian and New Zealand Urogenital and Prostate Cancer Trials Group · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2022-07-29
• Primary completion: 2024-11-01
• Completion: 2024-11-01
• First posted: 2021-06-09
• Last updated: 2024-11-22

Locations

8 sites across 1 country: Australia