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)

Condition: Metastatic Castrate-sensitive Prostate Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT05884398

Sponsor: Janssen Research & Development, LLC

Phase: Phase 3


  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • History of seizure or known condition that has been determined to significantly predispose to seizure per investigator
  • Pelvic lymph nodes as only site of metastasis
  • Known allergies, hypersensitivity, or intolerance to excipients of apalutamide
  • Any of the following within 6 months prior to screening: severe or unstable angina, myocardial infarction, symptomatic congestive heart failure, uncontrolled hypertension, clinically significant arterial or venous thromboembolic events
  • Gastrointestinal disorder affecting absorption

View trial on ClinicalTrials.gov