drugset / Trial / NCT03070886

Antiandrogen Therapy and Radiation Therapy With or Without Docetaxel in Treating Patients With Prostate Cancer That Has Been Removed by Surgery

NCT03070886 ↗

Phase 2/3 Active not recruiting 612 enrolled NRG Oncology National Cancer Institute (NCI) · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

This randomized phase II/III trial studies docetaxel, antiandrogen therapy, and radiation therapy to see how well it works compared with antiandrogen therapy and radiation therapy alone in treating patients with prostate cancer that has been removed by surgery. Androgen can cause the growth of prostate cells. Antihormone therapy may lessen the amount of androgen made by the body. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving antiandrogen therapy and radiation therapy with or without docetaxel after surgery may kill any remaining tumor cells.

Timeline

Start
2017-04-05
Primary completion
2025-10-31
Completion
2030-10-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Docetaxel Small molecule — Intravenous
Background Bicalutamide Other / unclassified — Oral
Background Degarelix Other / unclassified — Intramuscular
Background Flutamide Small molecule — Oral
Background Goserelin Other / unclassified — Intramuscular
Background Leuprolide Other / unclassified — Intramuscular
Background Nilutamide Small molecule — —