drugset
drugset / Trial / NCT03311555

A Salvage Trial of AR Inhibition With ADT and Apalutamide With Radiation Therapy Followed by Docetaxel in Men With PSA Recurrent Prostate Cancer After Radical Prostatectomy (STARTAR)

NCT03311555 ↗

Phase 2 Completed 39 enrolled Andrew J. Armstrong, MD
NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to describe the rate of 3-year progression free survival in men with recurrent PSA-only disease after prostatectomy, who receive combined apalutamide (ARN-509) and standard ADT with salvage radiation therapy followed by docetaxel, ADT, and apalutamide, AND who have had testosterone recovery to \>100 ng/dl at 36 months. The hypothesis is that AR inhibition with apalutamide added to standard salvage external beam radiation with androgen deprivation therapy, as well as the addition of 6 cycles of docetaxel, will further prolong progression free survival.

Timeline

Start
2018-03-28
Primary completion
2022-12-22
Completion
2022-12-22

Drugs

EvaluationDrugModalityDoseRoute
Subject Apalutamide Small molecule 240 mg —
Subject Docetaxel Small molecule 75 mg/m2 Intravenous
Background Decapeptyl Unknown 11.25 mg Intramuscular
Background Decapeptyl Unknown 22.5 mg Intramuscular
Background Degarelix Other / unclassified 120 mg Subcutaneous
Background Degarelix Other / unclassified 240 mg Subcutaneous
Background Goserelin Other / unclassified 10.8 mg Subcutaneous
Background Leuprolide Other / unclassified 22.5 mg Intramuscular
Background Leuprolide Other / unclassified 45 mg Intramuscular

Indications

prostate cancer