RECRUITING

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

Description

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.

Conditions

Metastatic Castrate-sensitive Prostate Cancer
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Related Conditions:

Metastatic Castrate-sensitive Prostate Cancer

Study Overview

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Study Details

Study overview

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.

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)

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

Condition
Metastatic Castrate-sensitive Prostate Cancer
Intervention / Treatment

-

Contacts and Locations

Homewood

Urology Centers Of Alabama, Homewood, Alabama, United States, 35209

Tucson

Arizona Urology Specialists, Tucson, Arizona, United States, 85741

Little Rock

Arkansas Urology, Little Rock, Arkansas, United States, 72211

Fresno

Urology Associates of Central California, Fresno, California, United States, 93720

San Francisco

VA Medical Center, San Francisco, California, United States, 94121

Santa Barbara

Sansum Clinic Pharm, Santa Barbara, California, United States, 93105

Lakewood

Colorado Clinical Research, Lakewood, Colorado, United States, 80228

Daytona Beach

Advanced Urology Institute, Daytona Beach, Florida, United States, 32114

Chicago Ridge

Associated Urological Specialists LLC, Chicago Ridge, Illinois, United States, 60415

Joliet

Advanced Urology Associates, Joliet, Illinois, United States, 60431

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Janssen Research & Development, LLC,

Janssen Research & Development, LLC Clinical Trial, STUDY_DIRECTOR, Janssen Research & Development, LLC

Study Record Dates

2027-04-14