drugset / Trial / NCT04918810

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

NCT04918810 ↗

NaSingle-groupOpen-labelTreatment

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.

Timeline

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

Outcome

Outcome not reported

Stopped (Enrollment): “Recruitment lower than expected. The proportion of patients with mGSTPi undetectable prior to chemo. was significantly higher than anticipated. Decision made to close due to insufficient patient numbers to able to obtain meaningful data collection.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Docetaxel Small molecule 50 mg/m2 —
Subject Docetaxel Small molecule 75 mg/m2 —