Trial purpose
Cancer treatment
Tumor type
Genitourinary
Age
18+
Clinical summary
Summary
Eligible participants will be randomly allocated to one of two experimental treatment arms.
In Experimental Arm A, participants with prostate-specific antigen (PSA) level <0.2ng/mL afeter 6 months of treatment with Apalutamide and Adrogen-Deprivation Therapy (ADT) during the initial treatment phase will enter the main treatment phase and be treated with apalutamide with intermittent ADT per protocol or followed up for at least 18 months from Day 1 of Cycle 7.
In Experimental Arm B, participants with PSA level <0.2ng/mL after 6 months of treatment with apalutamide and ADT during initial treatment phase will enter the main treatment phase and continue to receive apalutamide plus continious ADT or followed up for at least 18 months from Day 1 of Cycle 7.
Conditions
This trial is treating people with metastatic castrate-sensitive prostate cancer (mCSPC)
Eligibility
Inclusion
- 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
- 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
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- You are able to swallow medication by mouth.
Exclusion
- You have certain types of non-cancer medical conditions.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Janssen Research & Development, LLC
Scientific 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)
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