A Phase 3, Open-label, Randomized, Prospective Study of Apalutamide with Continued Versus Intermittent Androgen-Deprivation Therapy (ADT) following PSA Response in Participants with Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
Study of Apalutamide Alone or in Combination with ADT in Patients with Metastatic Castration-Sensitive Prostate Cancer (mCSPC)
Sponsor: Janssen Research and Development, LLC
Enrolling: Male Patients Only
IRB Number: AAAU8561
U.S. Govt. ID: NCT05884398
Contact: Research Nurse Navigator: 212-342-5162 / cancerclinicaltrials@cumc.columbia.edu
Additional Study Information: The purpose of this study is to help researchers understand more about the possible effectiveness and safety of apalutamide when given to patients with or without intermittent Androgen Deprivation Therapy (ADT) to treat metastatic Castration-Sensitive Prostate Cancer (mCSPC). Apalutamide is a type of drug that blocks the action of testosterone. By blocking the action of testosterone, it may slow down or stop the growth of prostate cancer cells. ADT works by stopping the body's production of testosterone. The reason for using ADT is that prostate cancer needs androgen to grow and survive so by starving the cancer of androgen it is hoped that the cancer will stop growing. Apalutamide is not being used in accordance to its labeling.
Karie D. Runcie, MD
Do You Qualify?
Are you at least 18 years old? Yes No
Have you been diagnosed with metastatic Castration-Sensitive Prostate Cancer (mCSPC)? Yes No
Are you able to swallow medications? Yes No
You may be eligible for this study

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