IDeate-Prostate01: This study is recruiting people with metastatic castration-resistant prostate cancer (mCRPC) to see whether treatment with a new medicine (called I-DXd) is more effective than chemotherapyA Phase 3, Open-label Study of Ifinatamab Deruxtecan Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Trial purpose

Cancer treatment

Tumor type

Genitourinary

Age

18+

Trial acronym

IDeate-Prostate01

Summary

Researchers are looking for new ways to treat metastatic castration-resistant prostate cancer (mCRPC). Researchers have designed a study medicine called ifinatamab deruxtecan (also called I-DXd or MK-2400) to treat mCRPC, which is a type of medicine called an antibody-drug conjugate (ADC). ADCs work by targeting a protein found on cancer cells and delivering treatment directly into the cell to damange it. 

The goal of this study is to learn if people who receive I-DXd live longer overall and live longer without the cancer growing or spreading than people who receive chemotherapy.

Eligible participants will be randomly allocated to one of two treatment arms.

In the Experimental Arm, participants will receive I-DXd as an intravenous (IV) infusion every 3 weeks.

In the Active Comparator Arm, participants will receive docetaxel chemotherapy as an IV infusion every 3 weeks, and a corticosteroid called prednisone as an oral tablet once per day.

Conditions

This trial is treating people with metastatic castration-resistant prostate cancer that has progressed while on androgen deprivation therapy