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Could pausing hormone therapy ease hot flashes without hurting cancer control?

NCT ID NCT05884398

Disease control Sponsor: Janssen Research & Development, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 4 times

Summary

This Phase 3 trial tests if men with metastatic prostate cancer who respond well to initial treatment with apalutamide and hormone therapy can safely pause the hormone therapy to reduce hot flashes. About 420 participants will be randomly assigned to continue or pause hormone therapy. The study measures whether pausing maintains cancer control and improves quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Apalutamide and androgen-deprivation therapy (ADT)
What this could lead to
If successful, this could allow men with metastatic prostate cancer to take breaks from hormone therapy, reducing side effects like hot flashes while still controlling the cancer.
What could go wrong
This is an early-stage Phase 3 trial with 420 participants, so results may not apply to all patients. There is a risk that pausing ADT could allow the cancer to progress faster.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

420 people

The number who actually took part.

Started

Aug 2023

Expected to finish

Oct 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

metastatic prostate carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Metastatic castrate-sensitive prostate cancer

Contacts and locations

Locations

  • Advanced Urology Associates

    Joliet, Illinois, 60431, United States

  • Advanced Urology Institute

    Daytona Beach, Florida, 32114, United States

  • Arizona Urology Specialists

    Tucson, Arizona, 85741, United States

  • Arkansas Urology

    Little Rock, Arkansas, 72211, United States

  • Associated Medical Professionals

    Syracuse, New York, 13210, United States

  • Associated Urological Specialists LLC

    Chicago Ridge, Illinois, 60415, United States

  • CEPHO Centro de Estudos e Pesquisa de Hematologia e Oncologia

    Santo André, 09060-650, Brazil

  • CHU de Quebec Universite Laval Hopital de l Enfant Jesus

    Québec, Quebec, G1J 1Z4, Canada

  • Centers for Advanced Urology LLC d b a MidLantic Urology

    Bala-Cynwyd, Pennsylvania, 19004, United States

  • Central Ohio Urology Group

    Gahanna, Ohio, 43230, United States

  • Centre Leon Berard

    Lyon, 69373, France

  • Centrum Onkologii im Prof F Lukaszczyka

    Bydgoszcz, 85 796, Poland

  • Chesapeake Urology Research Associates

    Towson, Maryland, 21204, United States

  • Chu Rennes Hopital Pontchaillou

    Rennes, 35000, France

  • Colorado Clinical Research

    Lakewood, Colorado, 80228, United States

  • Columbia University Medical Center

    New York, New York, 10032, United States

  • Consultorio de Especialidad en Urologia Privado

    Durango, 34000, Mexico

  • Cuidados Oncologicos

    Querétaro, 76000, Mexico

  • Del Sol Research Management, LLC

    Tucson, Arizona, 85715, United States

  • First Urology, PSC

    Jeffersonville, Indiana, 47130, United States

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

    São Paulo, 01246 000, Brazil

  • Fundacao Pio XII

    Barretos, 14784 400, Brazil

  • Gustave Roussy

    Villejuif, 94805, France

  • Helios Clinical Research, LLC

    Middleburg Heights, Ohio, 44130, United States

  • Hopital Cochin

    Paris, 75014, France

  • Hospital das Clínicas - Universidade Federal de Minas Gerais

    Belo Horizonte, 30130 100, Brazil

  • Houston Metro Urology

    Houston, Texas, 77027, United States

  • IDOR - Regional Bahia

    Salvador, 41253-190, Brazil

  • Institut Bergonie

    Bordeaux, 33076, France

  • Klinikum Augsburg

    Augsburg, D-86158, Germany

  • Klinikum rechts der Isar - der Technischen Universität München

    München, 81675, Germany

  • Liga Norte Riograndense Contra O Cancer

    Natal, 59062 000, Brazil

  • MSKCC Basking Ridge

    Basking Ridge, New Jersey, 07920, United States

  • MSKCC Bergen

    Montvale, New Jersey, 07645, United States

  • MSKCC Commack

    Commack, New York, 11725, United States

  • MSKCC Monmouth

    Middletown, New Jersey, 07748, United States

  • MSKCC Nassau Regional Cancer Center

    Uniondale, New York, 11553, United States

  • MSKCC Westchester

    Harrison, New York, 10604, United States

  • Macquarie University Hospital

    Macquarie University, 2109, Australia

  • Maryland Oncology Hematology P A

    Silver Spring, Maryland, 20904, United States

  • Mater Misericordiae Hospital

    South Brisbane, 4101, Australia

  • Medical Care & Research SA de CV

    Mérida, 97070, Mexico

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Michigan Institute of Urology

    Troy, Michigan, 48084, United States

  • Ministerio da Saude Instituto Nacional do Cancer

    Rio de Janeiro, 20230-130, Brazil

  • Nanfang Hospital of Southern Medical Hospital

    Guangzhou, 510515, China

  • Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy

    Warsaw, 02 781, Poland

  • Ningbo First Hospital

    Ningbo, 315010, China

  • Northwest Cancer Specialists PC

    Tigard, Oregon, 97223, United States

  • Nova Scotia Health Authority

    Halifax, Nova Scotia, B3H 2Y9, Canada

  • Oncology and Hematology Associates of Southwest Virginia, Inc.

    Roanoke, Virginia, 98684, United States

  • Parkland Health and Hospital System

    Dallas, Texas, 75235, United States

  • Peking University First Hospital

    Beijing, 100034, China

  • Peter MacCallum Cancer Centre

    Melbourne, 3000, Australia

  • Polimed Specjalistyczna Przychodnia Lekarska Wieslaw Grazyna Tupikowski Bednarek Tupikowska S C

    Wroclaw, 53 329, Poland

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9, Canada

  • SCIENTIA Investigacion Clinica SC

    Chihuahua City, 31207, Mexico

  • Sansum Clinic Pharm

    Santa Barbara, California, 93105, United States

  • Shandong Provincial Hospital

    Jinan, 250021, China

  • Shengjing Hospital Of China Medical University

    Shenyang, 110004, China

  • Southern Alberta Institute of Urology / Prostate Cancer Centre

    Calgary, Alberta, T2V 1P9, Canada

  • Studienpraxis Urologie Nurtingen

    Nürtingen, 72622, Germany

  • Sunnybrook Health Sciences Center

    Toronto, Ontario, M4N 3M5, Canada

  • Szpital Grochowski Im Dr Med Rafala Masztaka Sp Z O O

    Warsaw, 04 073, Poland

  • Szpital Wojewodzki im Mikolaja Kopernika w Koszalinie

    Koszalin, 75-581, Poland

  • Texas Oncology P A

    Austin, Texas, 78731, United States

  • Texas Oncology P A 1

    Wichita Falls, Texas, 76310, United States

  • Texas Oncology P A 2

    Houston, Texas, 77024, United States

  • Texas Oncology P A 3

    Dallas, Texas, 75246, United States

  • Texas Oncology San Antonio Northeast

    San Antonio, Texas, 78217, United States

  • The Conrad Pearson Clinic

    Germantown, Tennessee, 38138, United States

  • The First Affiliated Hospital Sun Yat sen University

    Guangzhou, 510080, China

  • The First Affiliated Hospital of Xian Jiaotong University

    Xi'an, 710061, China

  • The First Hospital of Jilin University

    Changchun, 130021, China

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

    Wuhan, 430030, China

  • TriState Urologic Services PSC Inc. DBA The Urology Group

    Cincinnati, Ohio, 45212, United States

  • UT Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • Universitaetsklinikum Carl Gustav Carus TU Dresden

    Dresden, 01307, Germany

  • Universitaetsklinikum Koelnt

    Cologne, 50937, Germany

  • Universitaetsklinikum der RWTH Aachen

    Aachen, 52074, Germany

  • Universitatsklinikum Schleswig Holstein Campus Lubeck

    Lübeck, 23538, Germany

  • Universitatsklinikum Wurzburg

    Würzburg, 97080, Germany

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15232, United States

  • University of Utah Huntsman Cancer Institute

    Salt Lake City, Utah, 84112, United States

  • Urology Associates

    Nashville, Tennessee, 37209, United States

  • Urology Associates of Central California

    Fresno, California, 93720, United States

  • Urology Centers Of Alabama

    Homewood, Alabama, 35209, United States

  • Urology Of Virginia, Pllc

    Virginia Beach, Virginia, 23462, United States

  • Urology of Indiana

    Greenwood, Indiana, 46143, United States

  • VA Medical Center

    San Francisco, California, 94121, United States

  • VA Pittsburgh

    Pittsburgh, Pennsylvania, 15240, United States

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502, United States

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

    Chengdu, 610041, China