USO 23062
Study Full Title: 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)
Disease Types: Genitourinary Cancer Research
Eligibility Requirements:
- Diagnosis of prostate cancer prior to screening with histologically or cytologically confirmed adenocarcinoma of the prostate
- Metastatic prostate cancer disease documented by conventional imaging (example, computed tomography [CT], magnetic resonance imaging [MRI], or bone scan) and/or next-generation imaging [NGI] demonstrating greater than equal (>=) 2 distinct extraprostatic sites of metastasis
- Have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1. Participants with ECOG PS 2 or 3 are eligible for the study if the ECOG PS score is related to stable physical limitations (example, wheelchair-bound due to prior spinal cord injury) and not related to prostate cancer or associated therapy
- A participant must agree not to plan to conceive a child while enrolled in this study or within 3 months after the last dose of study treatment
- Must be able to take whole apalutamide tablets by swallowing alone or with another vehicle (example, applesauce)
- Assigned male at birth, inclusive of all gender identities
- Participants who have undergone a bilateral orchidectomy and/or who are actively taking gender-affirming hormone therapy as part of their gender affirming care
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