Clinical Trial for Metastatic Castration-Resistant Prostate Cancer.

Who may participate

Each clinical study has its own guidelines for who may participate, called eligibility criteria. These factors can include your age, sex, overall health, type and stage of disease, and personal treatment history. However, only the research study staff can determine if you qualify to enroll in the study.

Condition

Metastatic Castration-Resistant Prostate Cancer

Sex

Male

Age

18+ years

Healthy participants

Visit ClinicalTrials.gov for more information

Eligibility criteria

Inclusion criteria

Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features.
Metastatic disease in bone documented on bone scan, or in soft tissue documented on CT/MRI scan.
Progressive disease in the setting of medical or surgical castration.
ECOG performance status 0 or 1, with a life expectancy of ≥12 months as assessed by the investigator.

Exclusion criteria

Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation in the past year or suicidal behavior in the past 5 years or laboratory abnormality that make the participant inappropriate for the study.
Known history of active inflammatory gastrointestinal disease, chronic diarrhea, or previous gastric resection or lap-band surgery.
Clinically significant cardiovascular disease.
Known or suspected brain metastasis or active leptomeningeal disease or clinically significant history of seizure.
Any history of myelodysplastic syndrome, acute myeloid leukemia, or any other prior malignancy with a few exceptions.
Participants must be treatment naïve at the mCRPC stage, eg, no cytotoxic chemotherapy, radio-ligand therapy (i.e. 177Lu- PSMA-617), CDK4/6 inhibitors, 5-alpha reductase inhibitors for prostate cancer in any setting, androgen receptor signaling inhibitors (ARSi) including enzalutamide, apalutamide, darolutamide, poly ADP-ribose polymerase (PARP) monotherapy or other systemic anti-cancer treatment with the following exceptions:
1. Treatment with first-generation antiandrogen (ADT) agents, estrogens, progestins, cyproterone acetate;
2. Docetaxel treatment is allowed for mCSPC, as long as no signs of failure, or disease progression occurred during treatment or within 3 months of treatment completion.
Previous administration with an investigational product (drug or vaccine) within 30 days or 5 half-lives preceding the first dose of study intervention (whichever is longer).
Inadequate organ function.

Study overview

This study will explore whether a combination of the investigational drug PF-06821497 and enzalutamide will work better than taking enzalutamide alone in participants with mCRPC who are ARSi or abiraterone naïve.

View locations for this study

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Miles

0500

Nearest Locations found

175 sites found

APSS- Presidio Ospedaliero S. Chiara

Trento, Italy, 38122

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AUC Urologists, LLC

Myrtle Beach, South Carolina, United States, 29572

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Accellacare of Duly

Lisle, Illinois, United States, 60532

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Adult & Pediatric Urology, PC

Omaha, Nebraska, United States, 68114

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Alexandra General Hospital of Athens

Athens, Attikí, Greece, 115 28

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Arkansas Urology - Little Rock

Little Rock, Arkansas, United States, 72211

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Athens Medical Center

Athens, Attikí, Greece, 151 25

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Auckland City Hospital

Auckland, New Zealand, 1023

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Azienda Ospedaliera Santa Maria Terni

Terni, Italy, 05100

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Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma

Verona, Italy, 37134

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Azienda Socio Sanitaria Territoriale di Cremona

Cremona, Italy, 26100

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Blessing Hospital

Quincy, Illinois, United States, 62301

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Blessing Physician Services

Quincy, Illinois, United States, 62301

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Borsod-Abaúj-Zemplén Vármegyei Központi Kórház és Egyetemi Oktatókórház

Miskolc, Borsod-Abauj Zemplen county, Hungary, 3526

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Bradfordhill

Santiago, Santiago Metropolitan, Chile, 8420383

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CHRISTUS St. Vincent Regional Cancer Center

Santa Fe, New Mexico, United States, 87505

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CHRU de Brest

Brest, Finistère, France, 29609

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CIUSSS- saguenay-Lac-Saint-Jean

Chicoutimi, Quebec, Canada, G7H 5H6

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Cancer Hospital Chinese Academy of Medical Science

Beijing, Beijing Municipality, China, 100021

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Canisius-Wilhelmina Ziekenhuis

Nijmegen, Gelderland, Netherlands, 6532 SZ

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Carolina Urologic Research Center, LLC

Myrtle Beach, South Carolina, United States, 29572

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Centre Hospitalier Lyon Sud

Pierre-Bénite, Rhône, France, 69310

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Centre Hospitalier Privé Saint-Grégoire

Saint-Grégoire, Ille-et-vilaine, France, 35760

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Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, Canada, H2X 3E4

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Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne

Clermont-Ferrand, France, 63011

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Centre Leon Berard

Lyon Cedex08, Auvergne-Rhône-Alpes, France, 69373

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Centro Medico Fleischer

Buenos Aires, Argentina, C1414

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Centro Medico Privado CEMAIC

Capital, Córdoba Province, Argentina, X5008HHW

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Centro de Estudios Clínicos SAGA

Santiago, Santiago Metropolitan, Chile, 7500653

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Centro de Investigacion Clinica del Sur

Temuco, Araucania, Chile, 4781156

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Centro de Urología (CDU)

CABA, Buenos Aires, Argentina, C1120AAT

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Chiba cancer center

Chiba, Chiba, Japan, 260-8717

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Christchurch Hospital

Christchurch, Canterbury, New Zealand, 8011

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Clinica Universidad Catolica del Maule

Talca, Maule Region, Chile, 3465584

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Clinique Victor Hugo Le Mans

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

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Complex Oncology Center - Plovdiv EOOD

Plovdiv, Bulgaria, 4004

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Cross Cancer Institute

Edmonton, Alberta, Canada, T6G 1Z2

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Duly Health and Care (Bone Scintigraphy)

Lisle, Illinois, United States, 60532

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Duly Health and Care (CT and MRI)

Westmont, Illinois, United States, 60559

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FALP

Santiago, Santiago Metropolitan, Chile, 7500921

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Fakultni Thomayerova nemocnice

Prague, Praha 4, Czechia, 14059

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Fakultni nemocnice Kralovske Vinohrady

Prague, Praha 10, Czechia, 10034

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Fakultni nemocnice Olomouc

Olomouc, Olomouc Region, Czechia, 779 00

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Fakultni nemocnice Ostrava

Ostrava, Moravian-Silesian Region, Czechia, 708 52

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Fakultní nemocnice Ostrava

Ostrava - Poruba, Moravian-Silesian Region, Czechia, 708 52

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First Affiliated Hospital of China Medical University

Shenyang, China, 110001

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore

Rome, Lazio, Italy, 00168

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Franciscus Gasthuis & Vlietland, Locatie Vlietland

Schiedam, South Holland, Netherlands, 3118 JH

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Fred Hutchinson Cancer Center

Seattle, Washington, United States, 98109

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Frisius Medisch Centrum

Leeuwarden, Provincie Friesland, Netherlands, 8934 AD

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Fujian Cancer Hospital

Fuzhou, Fujian, China, 350014

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Fundacion Arturo Lopez Perez

Providencia, Santiago Metropolitan, Chile, 7500966

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Fundación Arturo López Pérez

Providencia, Santiago Metropolitan, Chile, 7500836

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Grand Strand Medical Center

Myrtle Beach, South Carolina, United States, 29572

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Guangzhou First People's Hospital

Guangzhou, Guangdong, China, 510180

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Harborview Medical Center

Seattle, Washington, United States, 98104

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Helsinki university hospital

Helsinki, Finland, 00290

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Henan Cancer Hospital

Zhengzhou, Henan, China, 450008

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Highlands Oncology

Fayetteville, Arkansas, United States, 72703

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Highlands Oncology

Rogers, Arkansas, United States, 72758

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Highlands Oncology Group

Springdale, Arkansas, United States, 72762

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Hokkaido University Hospital

Sapporo, Hokkaido, Japan, 060-8648

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Hopitaux Universitaire de Strasbourg - Hopital Hautepierre

Strasbourg, Bas-rhin, France, 67098

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Hospital Alemao Oswaldo Cruz

São Paulo, São Paulo, Brazil, 01327-001

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Hospital Sirio Libanes

Capital Federal, Buenos Aires, Argentina, C1419AHN

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Huai'an First People's Hospital

Huai'an, Jiangsu, China, 223300

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Hunan Cancer Hospital

Changsha, Hunan, China, 410013

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IBCC - Núcleo de Pesquisa e Ensino

São Paulo, Brazil, 04014-002

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IC La Serena Research

La Serena, Coquimbo Region, Chile, 1720430

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IMAXE

Buenos Aires, Argentina, C1120

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IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"

Meldola, Emilia-Romagna, Italy, 47014

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IRCCS Istituto Clinico Humanitas

Rozzano, Milano, Italy, 20089

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Imagenes Mdq

Mar del Plata, Buenos Aires, Argentina, B7600FZO

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Imed Radiology

Tauranga, Bay of Plenty, New Zealand, 3112

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Inner Mongolia People's Hospital

Hohhot, Inner Mongolia, China, 010017

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Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest

Bordeaux, Aquitaine, France, 33076

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Institut Godinot

Reims, France, 51100

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Institut Jean Godinot

Reims, Marne, France, 51726

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Institut de Cancérologie de l'Ouest

Saint-Herblain, Loire-atlantique, France, 44805

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Instituto de Investigaciones Clínicas Mar del Plata

Mar del Plata, Buenos Aires, Argentina, B7600FZO

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Instituto do Cancer Arnaldo Vieira de Carvalho

São Paulo, Brazil, 01221-020

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