ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official 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)

Quick Facts

Study Start:2023-08-31
Study Completion:2026-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05884398

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:MALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosis of prostate cancer prior to screening with histologically or cytologically confirmed adenocarcinoma of the prostate
  2. * 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
  3. * 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
  4. * 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
  5. * For participants undergoing Gender-affirming care: There is no testosterone level requirement for inclusion
  6. * 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
  7. * 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
  8. * Must be able to take whole apalutamide tablets by swallowing alone or with another vehicle (example, applesauce)
  9. * Assigned male at birth, inclusive of all gender identities
  1. * History of seizure or known condition that has been determined to significantly predispose to seizure per investigator
  2. * Pelvic lymph nodes as only site of metastasis
  3. * Known allergies, hypersensitivity, or intolerance to excipients of apalutamide
  4. * 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
  5. * Gastrointestinal disorder affecting absorption
  6. * 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

Contacts and Locations

Principal Investigator

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

Study Locations (Sites)

Urology Centers Of Alabama
Homewood, Alabama, 35209
United States
Arizona Urology Specialists
Tucson, Arizona, 85741
United States
Arkansas Urology
Little Rock, Arkansas, 72211
United States
Urology Associates of Central California
Fresno, California, 93720
United States
VA Medical Center
San Francisco, California, 94121
United States
Sansum Clinic Pharm
Santa Barbara, California, 93105
United States
Colorado Clinical Research
Lakewood, Colorado, 80228
United States
Advanced Urology Institute
Daytona Beach, Florida, 32114
United States
Associated Urological Specialists LLC
Chicago Ridge, Illinois, 60415
United States
Advanced Urology Associates
Joliet, Illinois, 60431
United States
Urology of Indiana
Greenwood, Indiana, 46143
United States
First Urology, PSC
Jeffersonville, Indiana, 47130
United States
Maryland Oncology Hematology P A
Silver Spring, Maryland, 20904
United States
Chesapeake Urology Research Associates
Towson, Maryland, 21204
United States
Michigan Institute of Urology
Troy, Michigan, 48084
United States
MSKCC Basking Ridge
Basking Ridge, New Jersey, 07920
United States
MSKCC Monmouth
Middletown, New Jersey, 07748
United States
MSKCC Bergen
Montvale, New Jersey, 07645
United States
MSKCC Commack
Commack, New York, 11725
United States
MSKCC Westchester
Harrison, New York, 10604
United States
Columbia University Medical Center
New York, New York, 10032
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
Associated Medical Professionals
Syracuse, New York, 13210
United States
MSKCC Nassau Regional Cancer Center
Uniondale, New York, 11553
United States
TriState Urologic Services PSC Inc. DBA The Urology Group
Cincinnati, Ohio, 45212
United States
Central Ohio Urology Group
Gahanna, Ohio, 43230
United States
Helios Clinical Research, LLC
Middleburg Heights, Ohio, 44130
United States
Northwest Cancer Specialists PC
Tigard, Oregon, 97223
United States
Centers for Advanced Urology LLC d b a MidLantic Urology
Bala-Cynwyd, Pennsylvania, 19004
United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
United States
VA Pittsburgh
Pittsburgh, Pennsylvania, 15240
United States
The Conrad Pearson Clinic
Germantown, Tennessee, 38138
United States
Urology Associates
Nashville, Tennessee, 37209
United States
Texas Oncology P A
Austin, Texas, 78731
United States
Parkland Health and Hospital System
Dallas, Texas, 75235
United States
Texas Oncology P A
Dallas, Texas, 75246
United States
UT Southwestern Medical Center
Dallas, Texas, 75390
United States
Texas Oncology P A
Houston, Texas, 77024
United States
Houston Metro Urology
Houston, Texas, 77027
United States
Texas Oncology San Antonio Northeast
San Antonio, Texas, 78217
United States
Texas Oncology P A
Wichita Falls, Texas, 76310
United States
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah, 84112
United States
Virginia Oncology Associates
Norfolk, Virginia, 23502
United States
Oncology and Hematology Associates of Southwest Virginia, Inc.
Roanoke, Virginia, 98684
United States
Urology Of Virginia, Pllc
Virginia Beach, Virginia, 23462
United States

Collaborators and Investigators

Sponsor: Janssen Research & Development, LLC

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-31
Study Completion Date2026-08-31

Study Record Updates

Study Start Date2023-08-31
Study Completion Date2026-08-31

Terms related to this study

Additional Relevant MeSH Terms

  • Metastatic Castrate-sensitive Prostate Cancer