Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response

• Status: NOT_YET_RECRUITING
• Trial end date: 2034-06-01

Summary

The objective of this study is to determine the safety and clinical effects of alternating pharmacologic (i.e. supraphysiologic) testosterone therapy with darolutamide in men with metastatic prostate cancer as first line hormonal therapy. Correlative studies will be conducted to assess the effect of alternating therapy on quality of life, gene expression and metabolic changes associated with alternating therapy.

• Phase: PHASE2

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: Bayer
• Treatments: acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide; darolutamide; Gonadotropin-Releasing Hormone; Leuprolide; luprolide acetate gel depot; relugolix; testosterone 17 beta-cypionate; Triptorelin Pamoate