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New drug combo may slow advanced prostate cancer

NCT ID NCT03706365

Disease control Sponsor: Eli Lilly and Company 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 07, 2026 · Updated 1 time

Summary

This study tests whether adding the drug abemaciclib to standard treatment (abiraterone acetate plus prednisone) can help men with metastatic castration-resistant prostate cancer live longer without their cancer getting worse. About 393 participants will receive either the combination or a placebo. The main goal is to see if the new combination delays cancer progression on scans.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

393 people

The number who actually took part.

Started

Nov 2018

Expected to finish

Dec 2026

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: * Histologically confirmed adenocarcinoma of the prostate. * Metastatic prostate cancer documented by positive bone scan and/or measurable soft tissue metastatic lesions by CT or magnetic resonance imaging (MRI). * Progressive disease at study entry demonstrated during continuous androgen-deprivation therapy (ADT)/post orchiectomy defined as one or more of the following: * PSA progression * Radiographic progression per Response Evaluation Criteria in Solid Tumors (RECIST)1.1 for soft tissue and/or per Prostate Cancer Working Group 3 (PCWG3) for bone, with or without PSA progression * Have adequate organ function. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1. Exclusion Criteria: * Prior therapy with cytochrome P450 (CYP)17 inhibitors. * Prior treatment with abemaciclib or any cyclin-dependent kinase (CDK) 4 \& 6 inhibitors. * Prior cytotoxic chemotherapy for metastatic castration resistant prostate cancer (participants treated with docetaxel in the metastatic hormone-sensitive prostate cancer \[mHSPC\] are eligible). Prior radiopharmaceuticals for prostate cancer, or prior enzalutamide, apalutamide, darolutamide or sipuleucel-T. Participants who had prior radiation or surgery to all target lesions. * Currently enrolled in a clinical study involving an investigational product. * Gastrointestinal disorder affecting the absorption or ability to swallow large pills. * Clinically significant heart disease, active or chronic liver disease, moderate/severe hepatic impairment (Child-Pugh Class B and C).

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Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma metastatic prostate carcinoma prostate cancer

As listed by the trial registrant

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

Prostate cancer

Contacts and locations

Locations

  • Asan Medical Center

    Songpagu, Seoul-teukbyeolsi [Seoul], 5505, South Korea

  • Associated Medical Professionals - Urology

    Syracuse, New York, 13210, United States

  • Baylor Scott & White Medical Center - Temple

    Temple, Texas, 76508, United States

  • CBCC Global Research, Inc.

    Bakersfield, California, 93309, United States

  • CHD Vendee

    La Roche-sur-Yon, Vendée, 85000, France

  • CHU de Bordeaux Hop St ANDRE

    Bordeaux, 33075, France

  • Canisius-Wilhelmina Ziekenhuis

    Nijmegen, Gelderland, 6532 SZ, Netherlands

  • Centre Leon Berard

    Lyon, Auvergne-Rhône-Alpes, 69373, France

  • Centre de Cancérologie du Grand Montpellier

    Montpellier, Languedoc-Roussillon, 34070, France

  • Centrul de Oncologie "Sfântul Nectarie"

    Craiova, Dolj, 200542, Romania

  • Chris O'Brien Lifehouse

    Camperdown, New South Wales, 2050, Australia

  • Clinique Victor Hugo Le Mans

    Le Mans, Pays de la Loire Region, 72000, France

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89119, United States

  • Erasmus Medisch Centrum

    Rotterdam, South Holland, 3015 GD, Netherlands

  • Fort Wayne Medical Oncology And Hematology at Parkview Comprehensive Cancer Center

    Fort Wayne, Indiana, 46804, United States

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032, China

  • Gesundheitszentrum Holzminden

    Holzminden, Lower Saxony, 37603, Germany

  • Gifu University Hospital

    Gifu, 501-1112, Japan

  • Gral Medical Diagnostic Center

    Bucharest, 31422, Romania

  • Hamamatsu University Hospital

    Hamamatsu, Shizuoka, 431-3192, Japan

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150081, China

  • Henri Mondor Hospital

    Créteil, Île-de-France Region, France

  • Hirosaki University Hospital

    Hirosaki, Aomori, 036-8563, Japan

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648, Japan

  • Hospital Clínic de Barcelona

    Barcelona, Catalunya [Cataluña], 8036, Spain

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28009, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona [Barcelona], 8035, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, Madrid, Comunidad de, 28041, Spain

  • Hospital Universitario Ramón y Cajal

    Madrid, Madrid, Comunidad de, 28034, Spain

  • Hospital Universitario Virgen de la Victoria

    Málaga, Málaga, 29010, Spain

  • Huashan Hospital Affiliated Fudan University

    Shanghai, Shanghai Municipality, 200040, China

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013, China

  • Hunan Provincial People's Hospital

    Changsha, Hunan, 410005, China

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112, United States

  • Instituto Catalan de Oncologia - Hospital Duran i Reynals

    Hospitalet, Barcelona [Barcelona], 8907, Spain

  • Japanese Red Cross Nagoya Daini Hospital

    Nagoya, Aichi-ken, 466-8650, Japan

  • Jilin Province People's Hospital

    Changchun, Jilin, 130021, China

  • Kanazawa University Hospital

    Kanazawa, Ishikawa-ken, 920-8641, Japan

  • Kobe City Medical Center General Hospital

    Kobe, Hyōgo, 650-0047, Japan

  • Lanzhou university second hospital

    Lanzhou, Gansu, 730030, China

  • M Health Fairview University of Minnesota Medical Center - East Bank

    Minneapolis, Minnesota, 55455, United States

  • Macquarie University

    Macquarie University, New South Wales, 2109, Australia

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic in Arizona - Phoenix

    Phoenix, Arizona, 85054, United States

  • Millennium Oncology - Hollywood

    Hollywood, Florida, 33024, United States

  • Moores Cancer Center

    La Jolla, California, 92093, United States

  • Nanchong Central Hospital

    Nanchong, Sichuan, 637000, China

  • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical SchoolNanjing

    Nanjing, Jiangsu, 210000, China

  • Nantong Tumor Hospital

    Nantong, Jiangsu, 226361, China

  • National Hospital Organization Kumamoto Medical Center

    Kumamoto, 860-0008, Japan

  • New York Oncology Hematology (NYOH) - Clifton Park Cancer Center

    Albany, New York, 12206, United States

  • New York Oncology Hematology (NYOH) - Clifton Park Cancer Center

    The Woodlands, Texas, 77380, United States

  • Ningbo First Hospital

    Ningbo, Zhejiang, 315010, China

  • Northside Hospital

    Atlanta, Georgia, 30342, United States

  • Northwest Cancer Specialists PC

    The Woodlands, Texas, 77380, United States

  • Næstved Sygehus

    Næstved, Region Sjælland, 4700, Denmark

  • Osaka International Cancer Institute

    Osaka, 541-8567, Japan

  • Ovidius Clinical Hospital OCH

    Ovidiu, Constanța County, 905900, Romania

  • Pacific Cancer Care

    Monterey, California, 93940, United States

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3000, Australia

  • Prince of Wales Hospital

    Randwick, New South Wales, 2031, Australia

  • Private Practice - Dr. Ralf Eckert

    Eisleben Lutherstadt, Saxony-Anhalt, 06295, Germany

  • Private Practice - Dr. Silvio Szymula

    Leipzig, Saxony, 4105, Germany

  • Private Practice - Dr. Stammel & Dr. Garcia

    Wesel, North Rhine-Westphalia, 46483, Germany

  • Providence St. Jude Medical Center

    Fullerton, California, 92835, United States

  • Research Medical Center

    Nashville, Tennessee, 37203, United States

  • Rigshospitalet

    Copenhagen, Capital Region, 2100, Denmark

  • Rocky Mountain Cancer Center

    Lone Tree, Colorado, 80124, United States

  • Saitama Prefectural Cancer Center

    Ina-machi, Saitama, 362-0806, Japan

  • Samsung Medical Center

    Seoul, Seoul-teukbyeolsi [Seoul], 6351, South Korea

  • Sansum Clinic_Kendle

    Santa Barbara, California, 93105, United States

  • Sansum Clinic_Kendle

    The Woodlands, Texas, 77380, United States

  • Second Affiliated hospital of Anhui Medical University

    Hefei, Anhui, 230000, China

  • Seoul National University Hospital

    Seoul, Seoul-teukbyeolsi [Seoul], 3080, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, Seoul-teukbyeolsi [Seoul], 3722, South Korea

  • Showa University Hospital

    Shinagawa, Tokyo, 142-8555, Japan

  • Southside Cancer Care Centre

    Kogarah, New South Wales, 2228, Australia

  • St Vincent's Hospital

    Melbourne, Victoria, 3065, Australia

  • St. Antonius Ziekenhuis, locatie Utrecht

    Utrecht, 3543 AZ, Netherlands

  • St. Bernards Medical Center

    Jonesboro, Arkansas, 72401, United States

  • St. Joseph's Hospital and Medical Center

    Phoenix, Arizona, 85004, United States

  • Studienpraxis Urologie

    Nürtingen, Baden-Wurttemberg, 72622, Germany

  • Studienzentrum Bayenthal Urologische Partnerschaft Köln

    Cologne, North Rhine-Westphalia, 50968, Germany

  • Sun Yat-Sen University Cancer Centre

    Guangzhou, Guangdong, 510060, China

  • TRIO-US (Translational Research in Oncology-US)

    Los Angeles, California, 90024, United States

  • Texas Oncology - Longview Cancer Center

    The Woodlands, Texas, 77380, United States

  • Texas Oncology Cancer Care and Research Center

    The Woodlands, Texas, 77380, United States

  • Texas Oncology Fort Worth

    The Woodlands, Texas, 77380, United States

  • Texas Oncology-Memorial City

    The Woodlands, Texas, 77380, United States

  • The First Affiliated Hospital of Henan University of Science &Technology

    Luoyang, Henan, 471003, China

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006, China

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710061, China

  • The First Affiliated Hospital, Zhejiang University

    Hangzhou, Zhejiang, 310003, China

  • The Second Hospital of Tianjin Medical University

    Tianjin, Tianjin Municipality, 300211, China

  • The University of Arizona Cancer Center - North Campus

    Tucson, Arizona, 85719, United States

  • The University of Vermont Medical Center Inc.

    Burlington, Vermont, 05405, United States

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060, China

  • Toho University Sakura Medical Center

    Sakura, Chiba, 285-0841, Japan

  • Tongji Hospital Tongji Medical,Science & Technology

    Wuhan, Hubei, 430030, China

  • UCLA Hematology/Oncology - Westwood (Building 100)

    Los Angeles, California, 90095, United States

  • US Oncology

    The Woodlands, Texas, 77380, United States

  • USO-Cancer Care Center of Brevard, Inc.

    The Woodlands, Texas, 77380, United States

  • Universitaetsklinikum Tuebingen

    Tübingen, Baden-Wurttemberg, 72076, Germany

  • Universitätsklinikum Münster - Albert Schweitzer Campus

    Münster, North Rhine-Westphalia, 48149, Germany

  • Urologie Neandertal - Praxis Mettmann

    Mettmann, North Rhine-Westphalia, 40822, Germany

  • Wannan Medical College Yijishan Hospital

    Wuhu, Anhui, 241001, China

  • Wuhan Union Hospital

    Wuhan, Hubei, 430022, China

  • Wuxi People's Hospital

    Wuxi, Jiangsu, 214023, China

  • Xinjiang Medical University Cancer Hospital - Urumqi

    Ürümqi, Xinjiang, 830000, China

  • Yantai Yuhuangding Hospital

    Yantai, Shandong, 264099, China

  • Yokohama City University Medical Center

    Yokohama, Kanagawa, 232-0024, Japan

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang, 310014, China

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