A Phase II Study Assessing the Interruption of Hormonal Medications in Patients Responding Well to Therapy for Metastatic Prostate Cancer

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Full Title

A Phase 2 Trial of ADT Interruption in Patients Responding Exceptionally to AR-Pathway Inhibitor in Metastatic Hormone-Sensitive Prostate Cancer (MHSPC): A-DREAM (A032101) (CIRB)

Purpose

The usual treatment for people with metastatic prostate cancer is hormonal therapy, including a medication to lower testosterone levels in the body and a potent oral hormonal medication to block growth signals from male hormones in cancer cells. Patients whose cancer is responding exceptionally well to this therapy may be able to take a break from these medications, with guidance from their doctors. The purpose of this study is to see if it is possible to interrupt antiandrogen therapy in people with metastatic hormone-sensitive prostate cancer that is responding very well to androgen receptor-pathway inhibitor therapy.

Who Can Join

To be eligible for this study, patients must meet several requirements, including:

  • Participants in this study must have hormone-sensitive metastatic prostate cancer and be responding exceptionally well to hormonal therapy.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for people age 18 and older.

Contact

For more information about this study and to inquire about eligibility, please contact the office of Dr. Andrew Laccetti at 646-422-4683.

Protocol

22-345

Phase

II

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT05241860