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This Study Will Explore Whether a Combination of the Investigational Drug Mevrometostat (PF-06821497) and Enzalutamide Will Work Better Than Taking Enzalutamide Alone in Participants With mCSPC Who Are ARPI naïve.

NCT07028853 · Pfizer
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Official title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Mevrometostat (PF-06821497) With Enzalutamide in Metastatic Castration-Sensitive Prostate Cancer (MEVPRO-3)
About this study
This is a global, multicenter, randomized, double-blind, placebo-controlled Phase 3 study evaluating mevrometostat in combination with enzalutamide versus placebo in combination with enzalutamide in participants with mCSPC who have not received systemic anticancer treatments with the exception of androgen-deprivation therapy (ADT) and first-generation antiandrogen agents. Prior therapy with up to 3 months of ADT (chemical or surgical) is allowed, with no radiographic evidence of disease progression or rising PSA levels prior to Day 1. This study consists of a Screening Phase, Randomization, Treatment Phase, Safety Follow-up, and Long-Term Follow-up. Participants will be randomized on a 1:1 basis to receive (Arm A) mevrometostat (PF-06821497) in combination with enzalutamide, or (Arm B) placebo in combination with enzalutamide.
Eligibility criteria
Inclusion Criteria * Male participants aged ≥18 years (or the minimum age of consent in accordance with local regulations) at screening. * Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features. * Metastatic prostate cancer documented by positive bone scan (for bone disease) or metastatic lesion(s) on CT or MRI (for soft tissue/visceral disease). * Resolution of acute effects of any prior therapy to either baseline severity or CTCAE Grade ≤1 (except for AEs which do not constitute a safety risk in the investigator's judgement). * Participants must have ECOG PS 0 or 1. Exclusion Criteria * Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. * Clinically significant cardiovascular disease. * Known or suspected brain metastasis or active leptomeningeal disease. * Participants must be treatment naïve at the mCSPC stage, eg, participants cannot have received any cytotoxic chemotherapy with the following exceptions: Treatment with first-generation antiandrogen (ADT) agents is allowed for mCSPC. * Previous administration with an investigational product (drug or vaccine) within 30 days. * Use of 5-alpha reductase inhibitors is prohibited within 28 days of randomization. * Prior surgery from which the participant has not fully recovered at least 28 days prior to randomization * Current use or anticipated need for drugs that are known strong CYP3A4/5 inhibitors and inducers (with exception of enzalutamide as part of this study). * Inadequate organ function.
Study design
Enrollment target: 1000 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2025-09-28
Estimated completion: 2034-12-08
Last updated: 2026-03-30
Interventions
Drug: MevrometostatDrug: PlaceboDrug: Enzalutamide
Primary outcomes
  • Radiographic Progression Free Survival (rPFS) (Randomization up to approximately 4 years)
Sponsor
Pfizer · industry
Contacts & investigators
ContactPfizer CT.gov Call Center · contact · ClinicalTrials.gov_Inquiries@pfizer.com · 1-800-718-1021
InvestigatorPfizer CT.gov Call Center · study_director, Pfizer
All locations (253)
Clearview Cancer Institute (Crestwood)Not Yet Recruiting
Huntsville, Alabama, United States
Clearview Cancer InstituteNot Yet Recruiting
Huntsville, Alabama, United States
Ironwood Cancer & Research CentersRecruiting
Chandler, Arizona, United States
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Gilbert, Arizona, United States
Ironwood Cancer & Research CentersRecruiting
Glendale, Arizona, United States
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Goodyear, Arizona, United States
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Mesa, Arizona, United States
Ironwood Cancer & Research CentersRecruiting
Phoenix, Arizona, United States
Ironwood Cancer & Research CentersRecruiting
Scottsdale, Arizona, United States
Highlands Oncology Group, PARecruiting
Fayetteville, Arkansas, United States
Highlands Oncology Group, PARecruiting
Rogers, Arkansas, United States
Highlands Oncology Group, PARecruiting
Springdale, Arkansas, United States
UCLA Hematology/Oncology - AlhambraRecruiting
Alhambra, California, United States
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Atascadero, California, United States
Cedars-Sinai Cancer Beverly Hills (drug treatment and dispensing location)Not Yet Recruiting
Beverly Hills, California, United States
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Beverly Hills, California, United States
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Beverly Hills, California, United States
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Burbank, California, United States
UCLA Hematology/Oncology - EncinoRecruiting
Encino, California, United States
UCLA Hematology/Oncology - IrvineRecruiting
Irvine, California, United States
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Laguna Hills, California, United States
Cedars-Sinai Cancer at Cedars-Sinai Medical CenterNot Yet Recruiting
Los Angeles, California, United States
Ronald Reagan UCLA Medical Center - Drug Information CenterRecruiting
Los Angeles, California, United States
UCLA Department of Medicine - Hematology/OncologyRecruiting
Los Angeles, California, United States
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Los Angeles, California, United States
UCLA Hematology/Oncology - Marina del ReyRecruiting
Marina del Rey, California, United States
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Pasadena, California, United States
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Porter Ranch, California, United States
UCLA Hematology/Oncology - San Luis ObispoRecruiting
San Luis Obispo, California, United States
UCLA Hematology/Oncology - Santa BarbaraRecruiting
Santa Barbara, California, United States
UCLA Hematology/Oncology- Santa MonicaRecruiting
Santa Monica, California, United States
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Torrance, California, United States
UCLA Hematology/Oncology - Santa ClaritaRecruiting
Valencia, California, United States
UCLA Hematology/Oncology - VenturaRecruiting
Ventura, California, United States
UCLA Hematology/Oncology - WestlakeRecruiting
Westlake Village, California, United States
AdventHealth Medical Group Urology of DenverNot Yet Recruiting
Denver, Colorado, United States
Cancer Care Specialists of IllinoisRecruiting
Decatur, Illinois, United States
Cancer Care Specialists of IllinoisRecruiting
O'Fallon, Illinois, United States
University of Rochester Medical CenterNot Yet Recruiting
Rochester, New York, United States
University of Rochester, Cancer Center Pharmacy (Investigational Product)Not Yet Recruiting
Rochester, New York, United States
Montefiore Einstein Comprehensive Cancer CenterRecruiting
The Bronx, New York, United States
Montefiore Medical Center- Montefiore Medical ParkRecruiting
The Bronx, New York, United States
Duke Cancer Center CaryNot Yet Recruiting
Cary, North Carolina, United States
Duke University Medical Center (location of scans)Not Yet Recruiting
Durham, North Carolina, United States
Duke University Medical Center - Duke Cancer CenterNot Yet Recruiting
Durham, North Carolina, United States
Duke University Medical Center - Duke University Hospital (location of scans)Not Yet Recruiting
Durham, North Carolina, United States
Duke UniversityNot Yet Recruiting
Durham, North Carolina, United States
Duke Cancer Center RaleighNot Yet Recruiting
Raleigh, North Carolina, United States
Duke Raleigh HospitalNot Yet Recruiting
Raleigh, North Carolina, United States
Duke Women's Cancer Care Raleigh (Pharmacy location and location of CT, MRI and Bone scan machines)Not Yet Recruiting
Raleigh, North Carolina, United States
University Hospitals Seidman Cancer Center at UH Avon Health CenterRecruiting
Avon, Ohio, United States
TriState Urologic Services PSC Inc. dba The Urology GroupRecruiting
Cincinnati, Ohio, United States
University Hospitals Cleveland Medical CenterRecruiting
Cleveland, Ohio, United States
University Hospitals Seidman Cancer Center at UH Mentor Health CenterRecruiting
Mentor, Ohio, United States
UH Minoff Health Center at Chagrin HighlandsRecruiting
Orange, Ohio, United States
The Centers for Advanced Urology, LLP d/b/a Keystone Urology SpecialistsRecruiting
Lancaster, Pennsylvania, United States
Grand Strand Medical CenterRecruiting
Myrtle Beach, South Carolina, United States
Carolina Urologic Research Center, LLCRecruiting
Myrtle Beach, South Carolina, United States
Parkway Surgery CenterRecruiting
Myrtle Beach, South Carolina, United States
The West Clinic, PLLC dba West Cancer CenterNot Yet Recruiting
Germantown, Tennessee, United States
Urology Associates, P.C.Recruiting
Nashville, Tennessee, United States
University of Texas Southwestern Medical Center - Simmons Cancer CenterRecruiting
Dallas, Texas, United States
University of Texas Southwestern Medical Center - William P. Clements, Jr., University HospitalRecruiting
Dallas, Texas, United States
University of Texas Southwestern Simmons Cancer Center - RedbirdRecruiting
Dallas, Texas, United States
University of Texas Southwestern Medical Center-Zale Lipshy University HospitalRecruiting
Dallas, Texas, United States
University of Texas Southwestern Medical CenterRecruiting
Dallas, Texas, United States
University of Texas Southwestern Simmons Cancer Center - Fort WorthRecruiting
Fort Worth, Texas, United States
US Oncology Investigational Product Center (IPC)Recruiting
Irving, Texas, United States
University of Texas Southwestern Simmons Cancer Center - Richardson/PlanoRecruiting
Richardson, Texas, United States
Huntsman Cancer InstituteRecruiting
Salt Lake City, Utah, United States
Blue Ridge Cancer CareRecruiting
Blacksburg, Virginia, United States
Blue Ridge Cancer CareRecruiting
Low Moor, Virginia, United States
Blue Ridge Cancer CareRecruiting
Roanoke, Virginia, United States
Blue Ridge Cancer CareRecruiting
Salem, Virginia, United States
Blue Ridge Cancer CareRecruiting
Wytheville, Virginia, United States
Northwest Medical Specialties, PLLCRecruiting
Bonney Lake, Washington, United States
Northwest Medical Specialties, PLLCRecruiting
Federal Way, Washington, United States
Northwest Medical Specialties, PLLCRecruiting
Gig Harbor, Washington, United States
Northwest Medical Specialties, PLLCRecruiting
Puyallup, Washington, United States
Northwest Medical Specialties, PLLCRecruiting
Tacoma, Washington, United States
University of Wisconsin Carbone Cancer Center - Eastpark Medical CenterNot Yet Recruiting
Madison, Wisconsin, United States
University of Wisconsin Carbone Cancer Center - University HospitalNot Yet Recruiting
Madison, Wisconsin, United States
Asociación de Beneficencia Hospital Sirio LibanésNot Yet Recruiting
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Sanatorio BritánicoRecruiting
Rosario, Santa Fe Province, Argentina
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Rosario, Santa Fe Province, Argentina
Centro Oncologico KorbenNot Yet Recruiting
Buenos Aires, Argentina
Orange Health ServiceNot Yet Recruiting
Orange, New South Wales, Australia
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Wahroonga, New South Wales, Australia
Icon Cancer Centre ChermsideNot Yet Recruiting
Chermside, Queensland, Australia
Mater Misericordiae Limited Mater Cancer Care CentreRecruiting
South Brisbane, Queensland, Australia
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Kurralta Park, South Australia, Australia
Sir Charles Gairdner HospitalRecruiting
Nedlands, Western Australia, Australia
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Anderlecht, Bruxelles-capitale, Région de, Belgium
Jessa ZiekenhuisNot Yet Recruiting
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Aalst, Belgium
CEPHO - Centro de Estudos e Pesquisas de Hematologia e OncologiaRecruiting
Santo André, São Paulo, Brazil
MBAL Uni HospitalNot Yet Recruiting
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Medical Center FuturemedsRecruiting
Plovdiv, Bulgaria
Complex Oncology Center - Plovdiv EOODRecruiting
Plovdiv, Bulgaria
Prostate Cancer CentreRecruiting
Calgary, Alberta, Canada
Centre of Applied Urology Research/Nova Scotia Health AuthorityRecruiting
Halifax, Nova Scotia, Canada
Centre Intégré de Santé et de Services Sociaux de la Montérégie-CentreRecruiting
Greenfield Park, Quebec, Canada
Centre Hospitalier de l'Université de MontréalRecruiting
Montreal, Quebec, Canada
Jewish General HospitalRecruiting
Montreal, Quebec, Canada
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-JésusNot Yet Recruiting
Québec, Quebec, Canada
Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier UniverRecruiting
Sherbrooke, Quebec, Canada
Diex Recherche Trois-RivieresRecruiting
Trois-Rivières, Quebec, Canada
Wannan Medical College Yijishan HospitalRecruiting
Wuhu, Anhui, China
Peking University First HospitalNot Yet Recruiting
Beijing, Beijing Municipality, China
Beijing Friendship Hospital Affiliate of Capital UniversityRecruiting
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Chongqing Medical UniversityRecruiting
Chongqing, Chongqing Municipality, China
Chongqing University Cancer HospitalRecruiting
Chongqing, Chongqing Municipality, China
Lanzhou university second hospitalRecruiting
Lanzhou, Gansu, China
The First Affiliated Hospital of Guangzhou Medical UniversityRecruiting
Guangzhou, Guangdong, China
Sun Yat-sen University Cancer CenterNot Yet Recruiting
Guangzhou, Guangdong, China
Union Hospital Tongji Medical College Huazhong University of Science and TechnologyRecruiting
Wuhan, Hubei, China
Hunan Cancer HospitalRecruiting
Changsha, Hunan, China
First Huai'an Hospital Affiliated to Nanjing Medical UniversityRecruiting
Huai'an, Jiangsu, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical SchoolRecruiting
Nanjing, Jiangsu, China
Nantong Tumor HospitalRecruiting
Nantong, Jiangsu, China
The Second Affiliated Hospital of Soochow UniversityRecruiting
Suzhou, Jiangsu, China
The First Hospital of China Medical UniversityNot Yet Recruiting
Shenyang, Liangning, China
The First Affiliated Hospital of Xi'an Jiaotong UniversityRecruiting
Xi'an, Shaanxi, China
Qilu Hospital of Shandong UniversityRecruiting
Jinan, Shandong, China
Fudan University Shanghai Cancer CenterRecruiting
Shanghai, Shanghai Municipality, China
Suining Central HospitalRecruiting
Suining, Sichuan, China
Zhejiang Provincial People's HospitalNot Yet Recruiting
Hangzhou, Zhejiang, China
Sir Run Run Shaw Hospital of Zhejiang University School of MedicineRecruiting
Hangzhou, Zhejiang, China
The first affiliated hospital of Ningbo universityRecruiting
Ningbo, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical UniversityRecruiting
Wenzhou, Zhejiang, China
The Third Affiliated Hospital of Southern Medical UniversityRecruiting
Guangzhou, China
Masarykuv onkologicky ustavRecruiting
Brno, Czechia
Fakultni nemocnice Hradec KraloveRecruiting
Hradec Králové, Czechia
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Olomouc, Czechia
Urocentrum Praha s.r.o.Recruiting
Prague, Czechia
Fakultni Thomayerova nemocniceRecruiting
Prague, Czechia
Fakultni nemocnice v MotoleRecruiting
Prague, Czechia
Oulun yliopistollinen sairaalaNot Yet Recruiting
Oulu, North Ostrobothnia, Finland
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Tampere, Pirkanmaa, Finland
Vaasan KeskussairaalaRecruiting
Vaasa, Pohjanmaa, Finland
Turku University HospitalNot Yet Recruiting
Turku, Southwest Finland, Finland
Docrates SyöpäsairaalaRecruiting
Helsinki, Uusimaa, Finland
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Nice, Alpes-maritimes, France
Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud OuestNot Yet Recruiting
Bordeaux, Aquitaine, France
Centre Leon BerardNot Yet Recruiting
Lyon Cedex08, Auvergne-Rhône-Alpes, France
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Brest, Brittany Region, France
CHU BesançonNot Yet Recruiting
Besançon, Doubs, France
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Reims, Marne, France
Centre Hospitalier de la Côte BasqueNot Yet Recruiting
Bayonne, Pyrénées-atlantiques, France
Centre Hospitalier Lyon SudNot Yet Recruiting
Pierre-Bénite, Rhône, France
Gustave RoussyNot Yet Recruiting
Villejuif, Val-de-marne, France
Henri Mondor HospitalNot Yet Recruiting
Créteil, Île-de-France Region, France
Studienpraxis UrologieNot Yet Recruiting
Nürtingen, Baden-Wurttemberg, Germany
Universitaetsklinikum UlmNot Yet Recruiting
Ulm, Baden-Wurttemberg, Germany
Urologie Neandertal - Praxis MettmannNot Yet Recruiting
Mettmann, North Rhine-Westphalia, Germany
Universitätsklinikum Münster - Albert Schweitzer CampusNot Yet Recruiting
Münster, North Rhine-Westphalia, Germany
Charité Universitaetsmedizin BerlinNot Yet Recruiting
Berlin, Germany
Metropolitan HospitalNot Yet Recruiting
Athens, Greece
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Rabin Medical CenterRecruiting
Petah Tikva, Central District, Israel
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Ramat Gan, Central District, Israel
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Ẕerifin, Central District, Israel
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Jerusalem, Jerusalem, Israel
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Jerusalem, Jerusalem, Israel
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Haifa, Northern District, Israel
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Tel Aviv, TELL ABĪB, Israel
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Rozzano, Milano, Italy
Azienda Ospedaliero-Universitaria San Luigi GonzagaNot Yet Recruiting
Orbassano, Piedmont, Italy
Istituto Nazionale Tumori Regina ElenaNot Yet Recruiting
Rome, ROMA, Italy
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Novara, Italy
ASUIT Trento - Santa Chiara HospitalNot Yet Recruiting
Trento, Italy
Centro Ricerche Cliniche di VeronaNot Yet Recruiting
Verona, Italy
Chiba cancer centerRecruiting
Chiba, Chiba, Japan
National Hospital Organization Shikoku Cancer CenterRecruiting
Matsuyama, Ehime, Japan
National Hospital Organization Hokkaido Cancer CenterRecruiting
Sapporo, Hokkaido, Japan
Hokkaido University HospitalRecruiting
Sapporo, Hokkaido, Japan
Kobe University HospitalRecruiting
Kobe, Hyōgo, Japan
Kanazawa University HospitalRecruiting
Kanazawa, Ishikawa-ken, Japan
Yokohama City University Medical CenterRecruiting
Yokohama, Kanagawa, Japan
Yokosuka Kyosai HospitalRecruiting
Yokosuka, Kanagawa, Japan
The University of Osaka HospitalRecruiting
Suita, Osaka, Japan
Keio university hospitalRecruiting
Shinjuku-ku, Tokyo, Japan
National Hospital Organization Kyushu Cancer CenterRecruiting
Fukuoka, Japan
National Hospital Organization Kumamoto Medical CenterRecruiting
Kumamoto, Japan
Osaka International Cancer InstituteRecruiting
Osaka, Japan
Yamagata University HospitalRecruiting
Yamagata, Japan
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Nijmegen, Gelderland, Netherlands
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Tauranga, Bay of Plenty, New Zealand
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Christchurch, Canterbury, New Zealand
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Hamilton, Waikato Region, New Zealand
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Auckland, New Zealand
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Palmerston North, New Zealand
Clinical Research Center Spółka z ograniczoną odpowiedzialnością MEDIC-R Sp.kRecruiting
Poznan, Greater Poland Voivodeship, Poland
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Gdynia, Poland
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Krakow, Poland
Clinical Best Solutions Sp. z o.o. S.K.Recruiting
Lublin, Poland
Centrum Medyczne MEDYKRecruiting
Rzeszów, Poland
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Szczecin, Poland
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Prešov, Slovakia
Privatna urologicka ambulancia, s.r.o.Recruiting
Trenčín, Slovakia
Chonnam National University Hwasun HospitalRecruiting
Hwasun-gun, Jeonranamdo, South Korea
National Cancer CenterRecruiting
Goyang-si, Kyǒnggi-do, South Korea
Seoul National University Bundang HospitalRecruiting
Seongnam, Kyǒnggi-do, South Korea
Seoul National University HospitalRecruiting
Seoul, Seoul-teukbyeolsi [seoul], South Korea
Severance Hospital, Yonsei University Health SystemRecruiting
Seoul, Seoul-teukbyeolsi [seoul], South Korea
Asan Medical CenterRecruiting
Seoul, Seoul-teukbyeolsi [seoul], South Korea
Samsung Medical CenterRecruiting
Seoul, Seoul-teukbyeolsi [seoul], South Korea
Ewha Womans University Mokdong HospitalRecruiting
Seoul, Seoul-teukbyeolsi [seoul], South Korea
Kyungpook National University Chilgok HospitalRecruiting
Deagu, Taegu-kwangyǒkshi, South Korea
Chungnam national university hospitalRecruiting
Junggu, Taejǒn-kwangyǒkshi, South Korea
Parc de Salut Mar - Hospital del MarNot Yet Recruiting
Barcelona, Barcelona [barcelona], Spain
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Málaga, Málaga, Spain
CHUVI- Hospital Alvaro CunqueiroRecruiting
Vigo, Pontevedra [pontevedra], Spain
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Madrid, Spain
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Valencia, Spain
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Bern, Canton of Bern, Switzerland
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Winterthur, Switzerland
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Zurich, Switzerland
Kaohsiung Medical University Chung-Ho Memorial HospitalRecruiting
Kaohsiung City, Taiwan
Taichung Veterans General HospitalRecruiting
Taichung, Taiwan
National Cheng Kung University HospitalNot Yet Recruiting
Tainan, Taiwan
National Taiwan University HospitalNot Yet Recruiting
Taipei, Taiwan
Taipei Veterans General HospitalNot Yet Recruiting
Taipei, Taiwan
Chang Gung Medical Foundation-Linkou BranchNot Yet Recruiting
Taoyuan District, Taiwan
Royal Blackburn HospitalRecruiting
Blackburn, Blackburn WITH Darwen, United Kingdom
Velindre Cancer CentreNot Yet Recruiting
Cardiff, Cardiff [caerdydd Gb-crd], United Kingdom
Derriford HospitalNot Yet Recruiting
Plymouth, Devon, United Kingdom
Torbay HospitalRecruiting
Torquay, Devon, United Kingdom
Imperial College Healthcare NHS Trust, Charing Cross HospitalRecruiting
London, Hammersmith and Fulham, United Kingdom
Royal Marsden Hospital (Chelsea)Not Yet Recruiting
London, Kensington and Chelsea, United Kingdom
Maidstone HospitalNot Yet Recruiting
Maidstone, KENT, United Kingdom
Guy's & St Thomas' NHS Foundation TrustNot Yet Recruiting
London, London, CITY of, United Kingdom
Western General HospitalNot Yet Recruiting
Edinburgh, Midlothian, United Kingdom
The Christie NHS Foundation TrustRecruiting
Manchester, United Kingdom
This Study Will Explore Whether a Combination of the Investigational Drug Mevrometostat (PF-06821497) and Enzalutamide Will Work Better Than Taking Enzalutamide Alone in Participants With mCSPC Who Are ARPI naïve. · TrialPath