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

NCT05884398 | Active Not Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: CR10932756021927PCR30202022-502686-24-00
• Study Type: interventional
• Target: 420
• Locations: 9 countries
• Sites: 93

Brief Summary

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

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With 18-Months Radiographic Progression-free Survival (rPFS)

  rPFS is defined as the duration from the date of randomization to the date of first documentation of confirmed radiographic progressive disease or death due to any cause, whichever occurs first. rPFS will be assessed by investigators using conventional imaging (computed tomography \[CT\]/magnetic resonance imaging \[MRI\] and 99mTc bone scans).

  From randomization (Day 1 of Cycle 7) up to 18 months

• Percent Change From Randomization in Severity of Adjusted Hot Flash Score at 18 Months

  Severity adjusted hot flash score will be calculated from the hot flash diary which will be daily filled by the participants.

  From randomization (Day 1 of Cycle 7) up to 18 months

Secondary Outcomes (41)

• Mean Percentage Changes From Randomization in Severity Adjusted Hot Flash Score and Hot Flash Frequency

  From randomization (Day 1 of Cycle 7), up to 5 years

• Second Progression-free Survival (PFS2)

  From randomization (Day 1 of Cycle 7) up to 5 years

• Overall Survival (OS)

  From randomization (Day 1 of Cycle 7) up to 5 years

• Prostate Cancer-specific Survival

  From randomization (Day 1 Cycle 7) up to 5 years

• Serum Prostate Specific Antigen (PSA) Evaluations

  From randomization (Day 1 of Cycle 7) up to 5 years

Study Arms (2)

Arm A (Intermittent ADT Group)

EXPERIMENTAL

Participants with PSA level \<0.2 ng/mL after 6 months of treatment with Apalutamide and ADT during initial treatment phase, will enter main treatment phase and treated with apalutamide with intermittent ADT per protocol or followed up for at least 18 months from Day 1 of Cycle 7 (each cycle 28 days) and followed up for up to a maximum of 2 years after the main treatment phase, or until death, withdrawal of consent, loss to follow-up, early termination of the study by the sponsor for any reason, whichever occurs first.

Drug: Apalutamide; Drug: Androgen-deprivation Therapy (ADT)

Arm B (Continuous ADT Group)

ACTIVE COMPARATOR

Participants with PSA level \<0.2 ng/mL after 6 months of treatment with Apalutamide and ADT during initial treatment phase, will enter main treatment phase and continue to receive apalutamide plus ADT or followed up for at least 18 months from Day 1 of Cycle 7 (each cycle 28 days) and followed up for up to a maximum of 2 years after the main treatment phase, or until death, withdrawal of consent, loss to follow-up, early termination of the study by the sponsor for any reason, whichever occurs first.

Drug: Apalutamide; Drug: Androgen-deprivation Therapy (ADT)

Interventions

Apalutamide DRUG

Apalutamide will be administered orally from Day 1 of Cycle 1 till 6 months in initial treatment phase and then in main treatment phase from Day 1 of Cycle 7 up to at least 18 months.

Arm A (Intermittent ADT Group); Arm B (Continuous ADT Group)

Androgen-deprivation Therapy (ADT) DRUG

The choice of ADT will be at discretion of the Investigator. Dosing (dose and frequency of administration) will be consistent with the prescribing information.

Arm A (Intermittent ADT Group); Arm B (Continuous ADT Group)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Male assigned at birth, inclusive of all gender identities.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (93)

Urology Centers Of Alabama

Homewood, Alabama, 35209, United States

Location

Del Sol Research Management, LLC

Tucson, Arizona, 85715, United States

Location

Arizona Urology Specialists

Tucson, Arizona, 85741, United States

Location

Arkansas Urology

Little Rock, Arkansas, 72211, United States

Location

Urology Associates of Central California

Fresno, California, 93720, United States

Location

VA Medical Center

San Francisco, California, 94121, United States

Location

Sansum Clinic Pharm

Santa Barbara, California, 93105, United States

Location

Colorado Clinical Research

Lakewood, Colorado, 80228, United States

Location

Advanced Urology Institute

Daytona Beach, Florida, 32114, United States

Location

Associated Urological Specialists LLC

Chicago Ridge, Illinois, 60415, United States

Location

Advanced Urology Associates

Joliet, Illinois, 60431, United States

Location

Urology of Indiana

Greenwood, Indiana, 46143, United States

Location

First Urology, PSC

Jeffersonville, Indiana, 47130, United States

Location

Maryland Oncology Hematology P A

Silver Spring, Maryland, 20904, United States

Location

Chesapeake Urology Research Associates

Towson, Maryland, 21204, United States

Location

Michigan Institute of Urology

Troy, Michigan, 48084, United States

Location

MSKCC Basking Ridge

Basking Ridge, New Jersey, 07920, United States

Location

MSKCC Monmouth

Middletown, New Jersey, 07748, United States

Location

MSKCC Bergen

Montvale, New Jersey, 07645, United States

Location

MSKCC Commack

Commack, New York, 11725, United States

Location

MSKCC Westchester

Harrison, New York, 10604, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Associated Medical Professionals

Syracuse, New York, 13210, United States

Location

MSKCC Nassau Regional Cancer Center

Uniondale, New York, 11553, United States

Location

TriState Urologic Services PSC Inc. DBA The Urology Group

Cincinnati, Ohio, 45212, United States

Location

Central Ohio Urology Group

Gahanna, Ohio, 43230, United States

Location

Helios Clinical Research, LLC

Middleburg Heights, Ohio, 44130, United States

Location

Northwest Cancer Specialists PC

Tigard, Oregon, 97223, United States

Location

Centers for Advanced Urology LLC d b a MidLantic Urology

Bala-Cynwyd, Pennsylvania, 19004, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

Location

VA Pittsburgh

Pittsburgh, Pennsylvania, 15240, United States

Location

The Conrad Pearson Clinic

Germantown, Tennessee, 38138, United States

Location

Urology Associates

Nashville, Tennessee, 37209, United States

Location

Texas Oncology P A

Austin, Texas, 78731, United States

Location

Parkland Health and Hospital System

Dallas, Texas, 75235, United States

Location

Texas Oncology P A

Dallas, Texas, 75246, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Texas Oncology P A

Houston, Texas, 77024, United States

Location

Houston Metro Urology

Houston, Texas, 77027, United States

Location

Texas Oncology San Antonio Northeast

San Antonio, Texas, 78217, United States

Location

Texas Oncology P A

Wichita Falls, Texas, 76310, United States

Location

University of Utah Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Virginia Oncology Associates

Norfolk, Virginia, 23502, United States

Location

Oncology and Hematology Associates of Southwest Virginia, Inc.

Roanoke, Virginia, 98684, United States

Location

Urology Of Virginia, Pllc

Virginia Beach, Virginia, 23462, United States

Location

Macquarie University Hospital

Macquarie University, 2109, Australia

Location

Peter MacCallum Cancer Centre

Melbourne, 3000, Australia

Location

Mater Misericordiae Hospital

South Brisbane, 4101, Australia

Location

Fundacao Pio XII

Barretos, 14784 400, Brazil

Location

Hospital das Clínicas - Universidade Federal de Minas Gerais

Belo Horizonte, 30130-100, Brazil

Location

Liga Norte Riograndense Contra O Cancer

Natal, 59062 000, Brazil

Location

Ministerio da Saude Instituto Nacional do Cancer

Rio de Janeiro, 20230-130, Brazil

Location

Instituto D Or de Pesquisa e Ensino

Salvador, 41253 190, Brazil

Location

CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia

Santo André, 09060-650, Brazil

Location

Fundacao Faculdade de Medicina Instituto do Cancer do Estado de Sao Paulo

São Paulo, 01246 000, Brazil

Location

Southern Alberta Institute of Urology / Prostate Cancer Centre

Calgary, Alberta, T2V 1P9, Canada

Location

Nova Scotia Health Authority

Halifax, Nova Scotia, B3H 2Y9, Canada

Location

Sunnybrook Health Sciences Center

Toronto, Ontario, M4N 3M5, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

CHU de Quebec Universite Laval Hopital de l Enfant Jesus

Québec, Quebec, G1J 1Z4, Canada

Location

Peking University First Hospital

Beijing, 100034, China

Location

The First Hospital of Jilin University

Changchun, 130021, China

Location

West China School of Medicine/West China Hospital, Sichuan University

Chengdu, 610041, China

Location

The First Affiliated Hospital Sun Yat sen University

Guangzhou, 510080, China

Location

Nanfang Hospital of Southern Medical Hospital

Guangzhou, 510515, China

Location

Shandong Provincial Hospital

Jinan, 250021, China

Location

Ningbo First Hospital

Ningbo, 315010, China

Location

Shengjing Hospital Of China Medical University

Shenyang, 110004, China

Location

TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology

Wuhan, 430030, China

Location

The First Affiliated Hospital of Xian Jiaotong University

Xi'an, 710061, China

Location

Institut Bergonie

Bordeaux, 33076, France

Location

Centre Leon Berard

Lyon, 69373, France

Location

Hopital Cochin

Paris, 75014, France

Location

Chu Rennes Hopital Pontchaillou

Rennes, 35000, France

Location

Gustave Roussy

Villejuif, 94805, France

Location

Universitaetsklinikum der RWTH Aachen

Aachen, 52074, Germany

Location

Klinikum Augsburg

Augsburg, D-86158, Germany

Location

Universitaetsklinikum Koelnt

Cologne, 50937, Germany

Location

Universitaetsklinikum Carl Gustav Carus TU Dresden

Dresden, 01307, Germany

Location

Universitatsklinikum Schleswig Holstein Campus Lubeck

Lübeck, 23538, Germany

Location

Klinikum rechts der Isar - der Technischen Universität München

München, 81675, Germany

Location

Studienpraxis Urologie Nurtingen

Nürtingen, 72622, Germany

Location

Universitatsklinikum Wurzburg

Würzburg, 97080, Germany

Location

SCIENTIA Investigacion Clinica SC

Chihuahua City, 31207, Mexico

Location

Consultorio de Especialidad en Urologia Privado

Durango, 34000, Mexico

Location

Medical Care & Research SA de CV

Mérida, 97070, Mexico

Location

Cuidados Oncologicos

Querétaro, 76000, Mexico

Location

Centrum Onkologii im Prof F Lukaszczyka

Bydgoszcz, 85 796, Poland

Location

Szpital Wojewodzki im Mikolaja Kopernika w Koszalinie

Koszalin, 75-581, Poland

Location

Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

Warsaw, 02 781, Poland

Location

Szpital Grochowski Im Dr Med Rafala Masztaka Sp Z O O

Warsaw, 04 073, Poland

Location

Polimed Specjalistyczna Przychodnia Lekarska Wieslaw Grazyna Tupikowski Bednarek Tupikowska S C

Wroclaw, 53 329, Poland

Location

MeSH Terms

Interventions

apalutamide; Androgen Antagonists

Intervention Hierarchy (Ancestors)

Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2023
• First Posted: June 1, 2023
• Study Start: August 31, 2023
• Primary Completion (Estimated): October 12, 2026
• Study Completion (Estimated): October 12, 2028
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

AU (3); FR (5); DE (8); ME (4); CN (10); PL (5); US (46); BR (7); CA (5)