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A Study of an Intermittent ADT Approach With Apalutamide Monotherapy in Participants With mCSPC

Active Not RecruitingPhase 3

Sponsor: Janssen Research & Development, LLC

Conditions: Metastatic Castrate-sensitive Prostate Cancer

Interventions: Apalutamide, Androgen-deprivation Therapy (ADT)

Countries: United States, Australia, Brazil, Canada, China, France, Germany, Mexico

The purpose of the study is to determine if the intermittent use of androgen-deprivation therapy (ADT) in participants with metastatic castrate-sensitive prostate cancer (mCSPC) who reached a prostate-specific antigen (PSA) level \< 0.2 nanograms/millilitres (ng/mL) after 6 months of treatment with apalutamide and ADT combination therapy provides non-inferior radiographic progression-free survival (rPFS) and a reduced burden of hot flashes measured as 18-month percent change in severity adjusted hot flash score.

Eligibility overview

Sex: MALE

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Diagnosis of prostate cancer prior to screening with histologically or cytologically confirmed adenocarcinoma of the prostate
* For participants not undergoing Gender-affirming care: 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 or equal (\>=) 2 distinct extraprostatic sites of metastasis
* For participants undergoing Gender-affirming care: No evidence of metastasis by either conventional imaging (example, CT, MRI, or bone scan) and/or NGI is also acceptable
* For participants not undergoing gender-affirming care: testosterone levels \> 50 (ng/dL) nanograms per deciliter at screening, except for those who may have received ADT prior to screening. Participants are allowed to have received up to 3 months of (ADT) androgen-deprivation therapy prior to enrollment
* For participants undergoing Gender-affirming care: There is no testosterone level requirement for inclusion
* 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

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
* Participants who have undergone a bilateral orchiectomy with the exception of participants who completed this as part of their gender-affirming care or a result of a variation in physical sex development

Locations (93)

Homewood, Alabama, United States
Tucson, Arizona, United States
Tucson, Arizona, United States
Little Rock, Arkansas, United States
Fresno, California, United States
San Francisco, California, United States
Santa Barbara, California, United States
Lakewood, Colorado, United States
Daytona Beach, Florida, United States
Chicago Ridge, Illinois, United States
Joliet, Illinois, United States
Greenwood, Indiana, United States
Jeffersonville, Indiana, United States
Silver Spring, Maryland, United States
Towson, Maryland, United States
Troy, Michigan, United States
Basking Ridge, New Jersey, United States
Middletown, New Jersey, United States
Montvale, New Jersey, United States
Commack, New York, United States
Harrison, New York, United States
New York, New York, United States
New York, New York, United States
Syracuse, New York, United States
Uniondale, New York, United States
Cincinnati, Ohio, United States
Gahanna, Ohio, United States
Middleburg Heights, Ohio, United States
Tigard, Oregon, United States
Bala-Cynwyd, Pennsylvania, United States
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