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A Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Enzalutamide in Participants With Metastatic Castration-Resistant Prostrate Cancer (mCRPC) After Failure of an Androgen Synthesis Inhibitor And Failure of, Ineligibility For, or Refusal of a Taxane Regimen (IMbassador250)

Primary Purpose

Prostatic Neoplasms, Castration-Resistant

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Atezolizumab
Enzalutamide
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Neoplasms, Castration-Resistant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Life expectancy greater than or equal to (>/=) 3 months
  • Histologically confirmed adenocarcinoma of the prostate
  • Known castrate-resistant disease with serum testosterone level less than or equal to (</=) 50 nanograms per deciliter (ng/dL) with prior surgical castration or ongoing androgen deprivation for the duration of the study
  • Progressive disease prior to screening by PSA or imaging per PCWG3 criteria during or following the direct prior line of therapy in the setting of medical or surgical castration
  • One prior regimen/line of a taxane-containing regimen for mCRPC or refusal or ineligibility of a taxane-containing regimen
  • Progression on a prior regimen/line of an androgen synthesis inhibitor for prostate cancer
  • Availability of a representative tumor specimen from a site not previously irradiated that is suitable for determination of programmed death-ligand 1 (PD-L1) status via central testing
  • Adequate hematologic and end organ function

Exclusion Criteria:

  • Prior treatment with enzalutamide or any other newer hormonal androgen receptor inhibitor (e.g., apalutamide, ODM-201)
  • Treatment with any approved anti-cancer therapy, including chemotherapy, immunotherapy, radiopharmaceutical or hormonal therapy (with the exception of abiraterone), within 4 weeks prior to initiation of study treatment
  • Treatment with abiraterone within 2 weeks prior to study treatment
  • Structurally unstable bone lesions suggesting impending fracture
  • Known or suspected brain metastasis or active leptomeningeal disease
  • Major surgical procedure other than for diagnosis within 4 weeks prior to initiation of study treatment or anticipation of need for a major surgical procedure during the course of the study
  • Active or history of autoimmune disease or immune deficiency
  • Prior allogeneic stem cell or solid organ transplantation
  • History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
  • Positive human immunodeficiency virus (HIV) test, active tuberculosis, active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
  • Prior treatment with cluster of differentiation (CD)137 agonists or immune checkpoint blockade therapies, including anti Cytotoxic T Lymphocyte-Associated 4 (CTLA4), anti-programmed death 1 (PD-1), and anti-PD-L1 therapeutic antibodies
  • Treatment with systemic immunostimulatory agents within 4 weeks or five half-lives of the drug, whichever is shorter, prior to initiation of study treatment
  • Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study
  • History of seizure or any condition that may predispose to seizure within 12 months prior to study treatment, including history of unexplained loss of consciousness or transient ischemic attack

Sites / Locations

  • City of Hope Medical Grp Inc.
  • University of California San Diego
  • Kaiser Permanente San Diego - Los Angeles
  • UC Irvine Medical Center
  • Pacific Hematology Oncology Associates
  • University of Colorado; Division of Medical Oncology
  • Yale School of Medicine
  • Stamford Hospital; BCC, MOHR
  • Lynn Cancer Institute/Boca Raton Regional Hospital
  • SCRI Florida Cancer Specialists South
  • Miami Cancer Institute of Baptist Health, Inc.
  • Florida Cancer Specialist, North Region
  • Investigative Clin Rsch of IN
  • Associates in Oncology/Hematology P.C.
  • Dana-Farber Cancer Institute
  • Karmanos Cancer Institute..
  • Nebraska Cancer Specialists; Oncology Hematology West, PC
  • Urology Cancer Center & GU Research Network
  • Comprehensive Cancer Centers of Nevada
  • MSKCC at Basking Ridge
  • New York Oncology Hematology, P.C.
  • Columbia University Medical Center
  • Memorial Sloan-Kettering Cancer Center
  • Oncology Hematology Care, Inc.
  • James Cancer Hospital;Solove Research Institute
  • Penn State Milton S. Hershey Medical Center
  • Allegheny Cancer Center
  • University of Pittsburgh Cancer Institute; Division of Medical Oncology
  • Miriam Hospital
  • Charleston Oncology, P .A
  • Carolina Urologic Research Center
  • SCRI Tennessee Oncology Chattanooga
  • Texas Oncology Cancer Center
  • Texas Oncology - Methodist Dallas Cancer Center
  • Texas Oncology, P.A. - Fort Worth
  • Texas Oncology - Memorial City
  • Texas Oncology-Tyler
  • Virginia Cancer Specialists - Alexandria
  • Virginia Oncology Associates
  • Eastern Health; Cancer Services
  • Concord Repatriation General Hospital; Concord Cancer Centre
  • Macquarie University Hospital
  • Royal Brisbane & Women's Hosp; Cancer Care Serv
  • Adelaide Cancer Centre
  • Monash Medical Centre; Oncology
  • LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie
  • Ordensklinikum Linz Elisabethinen; Abteilung für Urologie und Andrologie
  • Medizinische Universität Wien; Universitätsklinik für Urologie
  • Onze Lieve Vrouwziekenhuis Aalst
  • UZ Gent
  • CHU Sart-Tilman
  • Tom Baker Cancer Centre-Calgary
  • Kingston General Hospital
  • Lakeridge Health Oshawa; Oncology
  • Princess Margaret Cancer Center
  • Hopital Charles Lemoyne; Centre Integre de Lutte Contre Le Cancer de La Monteregie
  • Jewish General Hospital
  • Centre Hospitalier Universitaire de Sherbrooke - Hopital Fleurimont
  • CHU de Québec - Université Laval - Hôtel-Dieu de Québec
  • Friendship Hospital, Capital Medical University
  • Jiangsu Cancer Hospital
  • Fudan University Shanghai Cancer Center
  • Zhongshan Hospital Fudan University
  • Masarykuv onkologicky ustav
  • Fakultni nemocnice u sv. Anny v Brne
  • Thomayerova nemocnice
  • Aalborg Universitetshospital; Klinik Kirurgi-Kræft, Onkologisk afd.
  • Herlev Hospital; Afdeling for Kræftbehandling
  • Odense Universitetshospital, Onkologisk Afdeling R
  • Institut Sainte-Catherine; Oncologie
  • Centre Francois Baclesse; Oncologie
  • Hopital Louis Pasteur; Medecine B
  • Centre Oscar Lambret; Chir Cancerologie General
  • Clinique Chenieux; Oncology
  • Hopital Saint Louis, Service D Oncologie Medicale
  • Hopital d'Instruction des Armees de Begin
  • Institut Claudius Regaud; Departement Oncologie Medicale
  • Institut Gustave Roussy
  • Universitätsklinikum Freiburg; Chirurgische Klinik; Abteilung Urologie
  • Medizinische Hochschule Hannover; Klinik für Urologie und Onkologische Urologie
  • Universitätsklinikum Münster, Klinik für Urologie und Kinderurologie
  • Universitätsklinikum Tübingen; Klinik für Urologie
  • Urologisches Zentrum Euregio; Würselen, Urologische Praxis am Wasserturm
  • Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine
  • Alexandras Hospital; Dept. of Clin. Therapeutics, Athens Uni School of Medicine
  • Athens Medical Center; Dept. of Oncology
  • IASO General Hospital of Athens
  • Agioi Anargyroi Cancer Hospital; 2Nd Oncology Dept.
  • University Hospital of Patras Medical Oncology
  • Papageorgiou General Hospital; Medical Oncology
  • Semmelwies University of Medicine; Urology Dept.
  • Orszagos Onkologiai Intezet; "C" Belgyógyászati-Onkológiai és Klinikai Farmakológiai Osztály
  • Debreceni Egyetem Klinikai Kozpont ; Department of Oncology
  • ISTITUTO NAZIONALE TUMORI IRCCS FONDAZIONE G. PASCALE; Dipartimento Uro-Ginecologico
  • A.O. Universitaria Policlinico Di Modena; Oncologia
  • Azienda Ospedaliera San Camillo Forlanini; Oncologia Medica
  • IRCCS AOU San Martino - IST; Oncologia Medica 1
  • A.O. Istituti Ospitalieri - Cremona; S.C. Oncologia
  • Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2
  • Irccs Istituto Europeo Di Oncologia (IEO); Cure Mediche
  • Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica
  • IRCCS Ospedale Casa Sollievo Della Sofferenza; Oncologia
  • Ospedale Area Aretina Nord; U.O.C. Oncologia
  • IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Prima
  • Nagoya City University Hospital
  • National Cancer Center East
  • Toho University Sakura Medical Center
  • Kyushu University Hospital
  • National Hospital Organization Hokkaido Cancer Center
  • Yokohama City University Medical Center
  • Kitasato University Hospital
  • University Hospital Kyoto Prefectural University of Medicine
  • Nara Medical University Hospital
  • Niigata University Medical & Dental Hospital
  • Kansai Medical University Hospital
  • Toranomon Hospital
  • The Jikei University Hospital
  • Nippon Medical School Hospital
  • National Cancer Center
  • Seoul National University Hospital
  • Asan Medical Center
  • Samsung Medical Center
  • Medical University of Bialystok; Oncology clinic
  • Przychodnia Lekarska KOMED, Roman Karaszewski
  • Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii
  • SPZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarawskiego
  • Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii
  • Szpital Sw. Elzbiety - Mokotowskie Centrum Medyczne Sp. z o.o.
  • Wojewodzki Szpital; Specjalistyczny ul.
  • Woj. Wielospec. Centrum Onkologii i Traumatologii
  • SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF
  • Russian Scientific Center of Roentgenoradiology
  • P.A. Herzen Oncological Inst. ; Oncology
  • Institut Catala d´Oncologia Hospital Germans Trias i Pujol
  • Insititut Catala D'Oncologia
  • Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
  • Hospital Universitario Reina Sofia; Servicio de Oncologia
  • Clinica Universitaria de Navarra; Servicio de Oncologia
  • Hospital Universitari Vall d'Hebron; Oncology
  • Hospital Clínic i Provincial; Servicio de Oncología
  • Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
  • Hospital Ramon y Cajal; Servicio de Oncologia
  • Hospital Clinico San Carlos; Servicio de Oncologia
  • Hospital Universitario 12 de Octubre; Servicio de Oncologia
  • Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
  • Hospital Universitario Virgen del Rocio; Servicio de Oncologia
  • Inselspital Bern; Universitätsklinik für medizinische Onkologie
  • Kantonsspital St. Gallen; Onkologie/Hämatologie
  • Taichung Veterans General Hospital; Division of Urology
  • National Taiwan University Hospital, Department of Urology
  • TAIPEI VETERANS GENERAL HOSPITAL, Urology
  • Chang Gung Memorial Hospital-LinKou; Urology
  • Royal Blackburn Hospital
  • Leicester Royal Infirmary
  • Barts and the London NHS Trust.
  • Sarah Cannon Research Institute
  • The Christie NHS Foundation Trust
  • Royal Marsden Hospital; Institute of Cancer Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Atezolizumab + Enzalutamide

Enzalutamide

Arm Description

Participants will receive atezolizumab along with enzalutamide until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity (up to approximately 42 months).

Participants will receive enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity (up to approximately 42 months).

Outcomes

Primary Outcome Measures

Overall Survival (OS)
Overall Survival is defined as the time from randomization to death from any cause.

Secondary Outcome Measures

Percentage of Participants Who Survived at Month 12 and 24
OS (Overall Survival is defined as the time from randomization to death from any cause) probability at 12 and 24 months
Time to First Symptomatic Skeletal Event (SSE)
An SSE is defined as external beam radiation therapy to relieve skeletal symptoms (including initiation of radium-223 dichloride or other types of radionuclide therapy to treat symptoms of bone metastases), new symptomatic pathologic bone fracture, clinically apparent occurrence of spinal cord compression, or tumor related orthopedic surgical intervention.
Radiographic Progression-Free Survival (rPFS), as Assessed by the Investigator and Adapted From the PCWG3 Criteria
rPFS is defined as the time from randomization to the earliest occurrence of one of the following: A participant is considered to have progressed by bone scan if: The first bone scan with ≥2 new lesions compared to baseline is observed < 12 weeks from randomization and is confirmed by a second bone scan taken ≥6 weeks later showing ≥2 additional new lesions (a total of ≥4 new lesions compared to baseline); the date of progression is the date of the first post-treatment scan, OR After the first post-treatment scan, ≥2 new lesions are observed relative to the first post-treatment scan, which is confirmed on a subsequent scan ≥6 weeks later; the date of progression is the date of the post-treatment scan when ≥2 new lesions were first documented. Progression of soft tissue lesions, as defined per PCWG3 modified RECIST v1.1 Death from any cause
Percentage of Participants Who Are Radiographic Progression-Free, as Assessed by the Investigator and Adapted From the PCWG3 Criteria
rPFS is defined as the time from randomization to the earliest occurrence of one of the following: A participant is considered to have progressed by bone scan if: The first bone scan with ≥2 new lesions compared to baseline is observed < 12 weeks from randomization and is confirmed by a second bone scan taken ≥6 weeks later showing ≥2 additional new lesions (a total of ≥4 new lesions compared to baseline); the date of progression is the date of the first post-treatment scan, OR After the first post-treatment scan, ≥2 new lesions are observed relative to the first post-treatment scan, which is confirmed on a subsequent scan ≥6 weeks later; the date of progression is the date of the post-treatment scan when ≥2 new lesions were first documented. Progression of soft tissue lesions, as defined per PCWG3 modified RECIST v1.1 Death from any cause
Percentage of Participants With Greater Than (>) 50 Percent (%) Decrease in Prostate-Specific Antigen (PSA) From Baseline
PSA response rate, defined as a > 50% decrease in PSA from baseline that is confirmed after ≥ 3 weeks by a consecutive confirmatory PSA measurement
Time to PSA Progression, Assessed as Per PCWG3 Criteria
In participants with no PSA decline from baseline, PSA progression is defined as a ≥25% increase and an absolute increase of ≥2 ng/mL above the baseline value, ≥12 weeks after baseline. In participants with an initial PSA decline from baseline, PSA progression is defined as a ≥25% increase and an absolute increase of ≥2 ng/mL above the nadir value, which is confirmed by a consecutive second value obtained ≥3 weeks later.
Percentage of Participant With Objective Response, as Determined by the Investigator Through Use of PCWG3 Criteria
Objective response rate in soft tissue lesions, defined as the percentage of participants with either a CR or PR on two consecutive occasions ≥ 6 weeks apart, as determined by the investigator through use of PCWG3 criteria
Percentage of Participants With Adverse Events
Verbatim description of adverse events will be coded to MedDRA preferred terms and graded according to NCI CTCAE v4.0.
Minimum Observed Serum Concentration (Cmin) of Atezolizumab
Atezolizumab serum concentration data (minimum [Cmin]) will be reported and summarized for each cycle where collected as appropriate.
Maximum Observed Serum Concentration (Cmax) of Atezolizumab
Atezolizumab serum concentration data (maximum [Cmax]) will be reported and summarized for each cycle where collected as appropriate.
Plasma Concentration of Enzalutamide
Plasma concentrations of Enzalutamide will be reported and summarized using descriptive statistics for each cycle and treatment arm, as appropriate.
Plasma Concentration of N-Desmethyl Enzalutamide
Plasma concentrations of N-desmethyl enzalutamide will be reported and summarized using descriptive statistics for each cycle and treatment arm, as appropriate.
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab
The numbers and proportions of ATA-positive participants and ATA-negative participants at baseline (baseline prevalence) and after baseline (post-baseline incidence) will be summarized by treatment group.

Full Information

First Posted
January 9, 2017
Last Updated
January 23, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT03016312
Brief Title
A Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Enzalutamide in Participants With Metastatic Castration-Resistant Prostrate Cancer (mCRPC) After Failure of an Androgen Synthesis Inhibitor And Failure of, Ineligibility For, or Refusal of a Taxane Regimen
Acronym
IMbassador250
Official Title
A Phase III, Multicenter, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Enzalutamide Versus Enzalutamide Alone in Patients With Metastatic Castration-Resistant Prostate Cancer After Failure of an Androgen Synthesis Inhibitor and Failure of, Ineligibility for, or Refusal of a Taxane Regimen
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
January 10, 2017 (Actual)
Primary Completion Date
December 20, 2022 (Actual)
Study Completion Date
December 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This Phase III, multicenter, randomized, open-label study will evaluate the safety and efficacy of atezolizumab (anti-programmed death-ligand 1 [anti-PD-L1] antibody) in combination with enzalutamide compared with enzalutamide alone in participants with mCRPC after failure of an androgen synthesis inhibitor (e.g., abiraterone) and failure of, ineligibility for, or refusal of a taxane regimen. Participants will be randomized to one of the two treatment arms (atezolizumab in combination with enzalutamide, and enzalutamide alone) in a 1:1 ratio (experimental to control arm) in global randomized phase. Participants will receive treatment until investigator-assessed confirmed radiographic disease progression per Prostate Cancer Working Group 3 (PCWG3) criteria or unacceptable toxicity.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms, Castration-Resistant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
772 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Atezolizumab + Enzalutamide
Arm Type
Experimental
Arm Description
Participants will receive atezolizumab along with enzalutamide until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity (up to approximately 42 months).
Arm Title
Enzalutamide
Arm Type
Active Comparator
Arm Description
Participants will receive enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity (up to approximately 42 months).
Intervention Type
Drug
Intervention Name(s)
Atezolizumab
Other Intervention Name(s)
Tecentriq®
Intervention Description
Atezolizumab will be administered at a fixed dose of 1200 milligrams (mg), intravenous (IV) infusion on Day 1 of each 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Enzalutamide
Other Intervention Name(s)
Xtandi®
Intervention Description
Enzalutamide capsules will be administered orally at a dose of 160 mg daily.
Primary Outcome Measure Information:
Title
Overall Survival (OS)
Description
Overall Survival is defined as the time from randomization to death from any cause.
Time Frame
Baseline until death from any cause (up to approximately 42 months)
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Survived at Month 12 and 24
Description
OS (Overall Survival is defined as the time from randomization to death from any cause) probability at 12 and 24 months
Time Frame
Months 12, 24
Title
Time to First Symptomatic Skeletal Event (SSE)
Description
An SSE is defined as external beam radiation therapy to relieve skeletal symptoms (including initiation of radium-223 dichloride or other types of radionuclide therapy to treat symptoms of bone metastases), new symptomatic pathologic bone fracture, clinically apparent occurrence of spinal cord compression, or tumor related orthopedic surgical intervention.
Time Frame
Baseline up to end of study (up to approximately 42 months)
Title
Radiographic Progression-Free Survival (rPFS), as Assessed by the Investigator and Adapted From the PCWG3 Criteria
Description
rPFS is defined as the time from randomization to the earliest occurrence of one of the following: A participant is considered to have progressed by bone scan if: The first bone scan with ≥2 new lesions compared to baseline is observed < 12 weeks from randomization and is confirmed by a second bone scan taken ≥6 weeks later showing ≥2 additional new lesions (a total of ≥4 new lesions compared to baseline); the date of progression is the date of the first post-treatment scan, OR After the first post-treatment scan, ≥2 new lesions are observed relative to the first post-treatment scan, which is confirmed on a subsequent scan ≥6 weeks later; the date of progression is the date of the post-treatment scan when ≥2 new lesions were first documented. Progression of soft tissue lesions, as defined per PCWG3 modified RECIST v1.1 Death from any cause
Time Frame
Baseline until disease progression or death from any cause (up to approximately 42 months)
Title
Percentage of Participants Who Are Radiographic Progression-Free, as Assessed by the Investigator and Adapted From the PCWG3 Criteria
Description
rPFS is defined as the time from randomization to the earliest occurrence of one of the following: A participant is considered to have progressed by bone scan if: The first bone scan with ≥2 new lesions compared to baseline is observed < 12 weeks from randomization and is confirmed by a second bone scan taken ≥6 weeks later showing ≥2 additional new lesions (a total of ≥4 new lesions compared to baseline); the date of progression is the date of the first post-treatment scan, OR After the first post-treatment scan, ≥2 new lesions are observed relative to the first post-treatment scan, which is confirmed on a subsequent scan ≥6 weeks later; the date of progression is the date of the post-treatment scan when ≥2 new lesions were first documented. Progression of soft tissue lesions, as defined per PCWG3 modified RECIST v1.1 Death from any cause
Time Frame
Months 6, 12
Title
Percentage of Participants With Greater Than (>) 50 Percent (%) Decrease in Prostate-Specific Antigen (PSA) From Baseline
Description
PSA response rate, defined as a > 50% decrease in PSA from baseline that is confirmed after ≥ 3 weeks by a consecutive confirmatory PSA measurement
Time Frame
Baseline until disease progression (up to approximately 42 months)
Title
Time to PSA Progression, Assessed as Per PCWG3 Criteria
Description
In participants with no PSA decline from baseline, PSA progression is defined as a ≥25% increase and an absolute increase of ≥2 ng/mL above the baseline value, ≥12 weeks after baseline. In participants with an initial PSA decline from baseline, PSA progression is defined as a ≥25% increase and an absolute increase of ≥2 ng/mL above the nadir value, which is confirmed by a consecutive second value obtained ≥3 weeks later.
Time Frame
Baseline until disease progression (up to approximately 42 months)
Title
Percentage of Participant With Objective Response, as Determined by the Investigator Through Use of PCWG3 Criteria
Description
Objective response rate in soft tissue lesions, defined as the percentage of participants with either a CR or PR on two consecutive occasions ≥ 6 weeks apart, as determined by the investigator through use of PCWG3 criteria
Time Frame
Baseline until disease progression or death from any cause (up to approximately 42 months)
Title
Percentage of Participants With Adverse Events
Description
Verbatim description of adverse events will be coded to MedDRA preferred terms and graded according to NCI CTCAE v4.0.
Time Frame
Baseline up to end of study (up to approximately 42 month
Title
Minimum Observed Serum Concentration (Cmin) of Atezolizumab
Description
Atezolizumab serum concentration data (minimum [Cmin]) will be reported and summarized for each cycle where collected as appropriate.
Time Frame
Pre-infusion (0 hour[hr]) on Day 1 Cycles 1, 2, 3, 4, 8, 12, 16 (Cycle length: 21 days); treatment discontinuation visit, 120 days after last dose (up to approximately 42 months)
Title
Maximum Observed Serum Concentration (Cmax) of Atezolizumab
Description
Atezolizumab serum concentration data (maximum [Cmax]) will be reported and summarized for each cycle where collected as appropriate.
Time Frame
Pre-infusion (0 hr) on Day 1 Cycles 1, 2, 3, 4, 8, 12, 16 (Cycle length: 21 days); 0.5 hr post-infusion (infusion duration: 60 minutes [min]) on Day 1 Cycle 1; treatment discontinuation visit, 120 days after last dose (up to approximately 42 months)
Title
Plasma Concentration of Enzalutamide
Description
Plasma concentrations of Enzalutamide will be reported and summarized using descriptive statistics for each cycle and treatment arm, as appropriate.
Time Frame
Predose (0 hr) and 1 hr postdose on Day 1 Cycle 1 and 3 (Cycle length: 21 days); pre-dose (within 1 hr) on Day 1 Cycle 8
Title
Plasma Concentration of N-Desmethyl Enzalutamide
Description
Plasma concentrations of N-desmethyl enzalutamide will be reported and summarized using descriptive statistics for each cycle and treatment arm, as appropriate.
Time Frame
Predose (0 hr) and 1 hr postdose on Day 1 Cycle 1 and 3 (Cycle length: 21 days); pre-dose (within 1 hr) on Day 1 Cycle 8
Title
Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab
Description
The numbers and proportions of ATA-positive participants and ATA-negative participants at baseline (baseline prevalence) and after baseline (post-baseline incidence) will be summarized by treatment group.
Time Frame
Predose (0 hr) on Day 1 Cycles 1, 2, 3, 4, 8, 12, 16 (Cycle length: 21 days); at atezolizumab discontinuation visit (30 days after last dose); 120 days after last dose of atezolizumab; up to 42 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Life expectancy greater than or equal to (>/=) 3 months Histologically confirmed adenocarcinoma of the prostate Known castrate-resistant disease with serum testosterone level less than or equal to (</=) 50 nanograms per deciliter (ng/dL) with prior surgical castration or ongoing androgen deprivation for the duration of the study Progressive disease prior to screening by PSA or imaging per PCWG3 criteria during or following the direct prior line of therapy in the setting of medical or surgical castration One prior regimen/line of a taxane-containing regimen for mCRPC or refusal or ineligibility of a taxane-containing regimen Progression on a prior regimen/line of an androgen synthesis inhibitor for prostate cancer Availability of a representative tumor specimen from a site not previously irradiated that is suitable for determination of programmed death-ligand 1 (PD-L1) status via central testing Adequate hematologic and end organ function Exclusion Criteria: Prior treatment with enzalutamide or any other newer hormonal androgen receptor inhibitor (e.g., apalutamide, ODM-201) Treatment with any approved anti-cancer therapy, including chemotherapy, immunotherapy, radiopharmaceutical or hormonal therapy (with the exception of abiraterone), within 4 weeks prior to initiation of study treatment Treatment with abiraterone within 2 weeks prior to study treatment Structurally unstable bone lesions suggesting impending fracture Known or suspected brain metastasis or active leptomeningeal disease Major surgical procedure other than for diagnosis within 4 weeks prior to initiation of study treatment or anticipation of need for a major surgical procedure during the course of the study Active or history of autoimmune disease or immune deficiency Prior allogeneic stem cell or solid organ transplantation History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan Positive human immunodeficiency virus (HIV) test, active tuberculosis, active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection Prior treatment with cluster of differentiation (CD)137 agonists or immune checkpoint blockade therapies, including anti Cytotoxic T Lymphocyte-Associated 4 (CTLA4), anti-programmed death 1 (PD-1), and anti-PD-L1 therapeutic antibodies Treatment with systemic immunostimulatory agents within 4 weeks or five half-lives of the drug, whichever is shorter, prior to initiation of study treatment Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study History of seizure or any condition that may predispose to seizure within 12 months prior to study treatment, including history of unexplained loss of consciousness or transient ischemic attack
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
City of Hope Medical Grp Inc.
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
University of California San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Kaiser Permanente San Diego - Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
UC Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Pacific Hematology Oncology Associates
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
University of Colorado; Division of Medical Oncology
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80021
Country
United States
Facility Name
Yale School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Stamford Hospital; BCC, MOHR
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06904
Country
United States
Facility Name
Lynn Cancer Institute/Boca Raton Regional Hospital
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
SCRI Florida Cancer Specialists South
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33916
Country
United States
Facility Name
Miami Cancer Institute of Baptist Health, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Florida Cancer Specialist, North Region
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
Investigative Clin Rsch of IN
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Associates in Oncology/Hematology P.C.
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Karmanos Cancer Institute..
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Nebraska Cancer Specialists; Oncology Hematology West, PC
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Name
Urology Cancer Center & GU Research Network
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
MSKCC at Basking Ridge
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Facility Name
New York Oncology Hematology, P.C.
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Oncology Hematology Care, Inc.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45230
Country
United States
Facility Name
James Cancer Hospital;Solove Research Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Allegheny Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
University of Pittsburgh Cancer Institute; Division of Medical Oncology
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Charleston Oncology, P .A
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Carolina Urologic Research Center
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
SCRI Tennessee Oncology Chattanooga
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Texas Oncology Cancer Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Texas Oncology - Methodist Dallas Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75203
Country
United States
Facility Name
Texas Oncology, P.A. - Fort Worth
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Texas Oncology - Memorial City
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Texas Oncology-Tyler
City
Irving
State/Province
Texas
ZIP/Postal Code
75063
Country
United States
Facility Name
Virginia Cancer Specialists - Alexandria
City
Alexandria
State/Province
Virginia
ZIP/Postal Code
22304
Country
United States
Facility Name
Virginia Oncology Associates
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Eastern Health; Cancer Services
City
Box Hill
State/Province
New South Wales
ZIP/Postal Code
3128
Country
Australia
Facility Name
Concord Repatriation General Hospital; Concord Cancer Centre
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Facility Name
Macquarie University Hospital
City
Macquarie Park
State/Province
New South Wales
ZIP/Postal Code
2109
Country
Australia
Facility Name
Royal Brisbane & Women's Hosp; Cancer Care Serv
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Adelaide Cancer Centre
City
Kurralta Park
State/Province
South Australia
ZIP/Postal Code
5037
Country
Australia
Facility Name
Monash Medical Centre; Oncology
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Ordensklinikum Linz Elisabethinen; Abteilung für Urologie und Andrologie
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
Medizinische Universität Wien; Universitätsklinik für Urologie
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Onze Lieve Vrouwziekenhuis Aalst
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Facility Name
UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
CHU Sart-Tilman
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Tom Baker Cancer Centre-Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Kingston General Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 2V7
Country
Canada
Facility Name
Lakeridge Health Oshawa; Oncology
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1G 2B9
Country
Canada
Facility Name
Princess Margaret Cancer Center
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1Z5
Country
Canada
Facility Name
Hopital Charles Lemoyne; Centre Integre de Lutte Contre Le Cancer de La Monteregie
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H1
Country
Canada
Facility Name
Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Sherbrooke - Hopital Fleurimont
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
CHU de Québec - Université Laval - Hôtel-Dieu de Québec
City
Quebec
ZIP/Postal Code
G1J 1Z4
Country
Canada
Facility Name
Friendship Hospital, Capital Medical University
City
Beijing
ZIP/Postal Code
100050
Country
China
Facility Name
Jiangsu Cancer Hospital
City
Nanjing City
ZIP/Postal Code
211100
Country
China
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai City
ZIP/Postal Code
200120
Country
China
Facility Name
Zhongshan Hospital Fudan University
City
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Masarykuv onkologicky ustav
City
Brno
ZIP/Postal Code
656 53
Country
Czechia
Facility Name
Fakultni nemocnice u sv. Anny v Brne
City
Brno
ZIP/Postal Code
656 91
Country
Czechia
Facility Name
Thomayerova nemocnice
City
Praha 4 - Krc
ZIP/Postal Code
140 59
Country
Czechia
Facility Name
Aalborg Universitetshospital; Klinik Kirurgi-Kræft, Onkologisk afd.
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Herlev Hospital; Afdeling for Kræftbehandling
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Odense Universitetshospital, Onkologisk Afdeling R
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Institut Sainte-Catherine; Oncologie
City
Avignon
ZIP/Postal Code
84082
Country
France
Facility Name
Centre Francois Baclesse; Oncologie
City
Caen
ZIP/Postal Code
14076
Country
France
Facility Name
Hopital Louis Pasteur; Medecine B
City
Colmar
ZIP/Postal Code
68024
Country
France
Facility Name
Centre Oscar Lambret; Chir Cancerologie General
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Clinique Chenieux; Oncology
City
Limoges
ZIP/Postal Code
87039
Country
France
Facility Name
Hopital Saint Louis, Service D Oncologie Medicale
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Hopital d'Instruction des Armees de Begin
City
Saint-Mande
ZIP/Postal Code
94160
Country
France
Facility Name
Institut Claudius Regaud; Departement Oncologie Medicale
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Universitätsklinikum Freiburg; Chirurgische Klinik; Abteilung Urologie
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Medizinische Hochschule Hannover; Klinik für Urologie und Onkologische Urologie
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Universitätsklinikum Münster, Klinik für Urologie und Kinderurologie
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Universitätsklinikum Tübingen; Klinik für Urologie
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Urologisches Zentrum Euregio; Würselen, Urologische Praxis am Wasserturm
City
Würselen
ZIP/Postal Code
52146
Country
Germany
Facility Name
Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine
City
Athens
ZIP/Postal Code
115 22
Country
Greece
Facility Name
Alexandras Hospital; Dept. of Clin. Therapeutics, Athens Uni School of Medicine
City
Athens
ZIP/Postal Code
115 28
Country
Greece
Facility Name
Athens Medical Center; Dept. of Oncology
City
Athens
ZIP/Postal Code
151 25
Country
Greece
Facility Name
IASO General Hospital of Athens
City
Athens
ZIP/Postal Code
155 62
Country
Greece
Facility Name
Agioi Anargyroi Cancer Hospital; 2Nd Oncology Dept.
City
Kifisia
ZIP/Postal Code
145 64
Country
Greece
Facility Name
University Hospital of Patras Medical Oncology
City
Patras
ZIP/Postal Code
265 04
Country
Greece
Facility Name
Papageorgiou General Hospital; Medical Oncology
City
Thessaloniki
ZIP/Postal Code
564 29
Country
Greece
Facility Name
Semmelwies University of Medicine; Urology Dept.
City
Budapest
ZIP/Postal Code
1082
Country
Hungary
Facility Name
Orszagos Onkologiai Intezet; "C" Belgyógyászati-Onkológiai és Klinikai Farmakológiai Osztály
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpont ; Department of Oncology
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
ISTITUTO NAZIONALE TUMORI IRCCS FONDAZIONE G. PASCALE; Dipartimento Uro-Ginecologico
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
A.O. Universitaria Policlinico Di Modena; Oncologia
City
Modena
State/Province
Emilia-Romagna
ZIP/Postal Code
41100
Country
Italy
Facility Name
Azienda Ospedaliera San Camillo Forlanini; Oncologia Medica
City
Roma
State/Province
Lazio
ZIP/Postal Code
00152
Country
Italy
Facility Name
IRCCS AOU San Martino - IST; Oncologia Medica 1
City
Genova
State/Province
Liguria
ZIP/Postal Code
16132
Country
Italy
Facility Name
A.O. Istituti Ospitalieri - Cremona; S.C. Oncologia
City
Cremona
State/Province
Lombardia
ZIP/Postal Code
26100
Country
Italy
Facility Name
Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20133
Country
Italy
Facility Name
Irccs Istituto Europeo Di Oncologia (IEO); Cure Mediche
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20141
Country
Italy
Facility Name
Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica
City
Bari
State/Province
Puglia
ZIP/Postal Code
70124
Country
Italy
Facility Name
IRCCS Ospedale Casa Sollievo Della Sofferenza; Oncologia
City
San Giovanni Rotondo
State/Province
Puglia
ZIP/Postal Code
71013
Country
Italy
Facility Name
Ospedale Area Aretina Nord; U.O.C. Oncologia
City
Arezzo
State/Province
Toscana
ZIP/Postal Code
52100
Country
Italy
Facility Name
IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Prima
City
Padova
State/Province
Veneto
ZIP/Postal Code
35128
Country
Italy
Facility Name
Nagoya City University Hospital
City
Aichi
ZIP/Postal Code
467-8602
Country
Japan
Facility Name
National Cancer Center East
City
Chiba
ZIP/Postal Code
277-8577
Country
Japan
Facility Name
Toho University Sakura Medical Center
City
Chiba
ZIP/Postal Code
285-8741
Country
Japan
Facility Name
Kyushu University Hospital
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
National Hospital Organization Hokkaido Cancer Center
City
Hokkaido
ZIP/Postal Code
003-0804
Country
Japan
Facility Name
Yokohama City University Medical Center
City
Kanagawa
ZIP/Postal Code
232-0024
Country
Japan
Facility Name
Kitasato University Hospital
City
Kanagawa
ZIP/Postal Code
252-0375
Country
Japan
Facility Name
University Hospital Kyoto Prefectural University of Medicine
City
Kyoto
ZIP/Postal Code
602-8566
Country
Japan
Facility Name
Nara Medical University Hospital
City
Nara
ZIP/Postal Code
634-8522
Country
Japan
Facility Name
Niigata University Medical & Dental Hospital
City
Niigata
ZIP/Postal Code
951-8520
Country
Japan
Facility Name
Kansai Medical University Hospital
City
Osaka
ZIP/Postal Code
573-1191
Country
Japan
Facility Name
Toranomon Hospital
City
Tokyo
ZIP/Postal Code
105-8470
Country
Japan
Facility Name
The Jikei University Hospital
City
Tokyo
ZIP/Postal Code
105-8471
Country
Japan
Facility Name
Nippon Medical School Hospital
City
Tokyo
ZIP/Postal Code
113-8603
Country
Japan
Facility Name
National Cancer Center
City
Goyang-si
ZIP/Postal Code
10408
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Medical University of Bialystok; Oncology clinic
City
Bialystok
ZIP/Postal Code
15-027
Country
Poland
Facility Name
Przychodnia Lekarska KOMED, Roman Karaszewski
City
Konin
ZIP/Postal Code
62-500
Country
Poland
Facility Name
Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii
City
Kraków
ZIP/Postal Code
30-688
Country
Poland
Facility Name
SPZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarawskiego
City
Opole
ZIP/Postal Code
45-060
Country
Poland
Facility Name
Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii
City
Otwock
ZIP/Postal Code
05-400
Country
Poland
Facility Name
Szpital Sw. Elzbiety - Mokotowskie Centrum Medyczne Sp. z o.o.
City
Warszawa
ZIP/Postal Code
02-616
Country
Poland
Facility Name
Wojewodzki Szpital; Specjalistyczny ul.
City
Wroclaw
ZIP/Postal Code
51-124
Country
Poland
Facility Name
Woj. Wielospec. Centrum Onkologii i Traumatologii
City
Łódź
ZIP/Postal Code
93-513
Country
Poland
Facility Name
SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF
City
Sankt-peterburg
State/Province
Leningrad
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Russian Scientific Center of Roentgenoradiology
City
Moscow
ZIP/Postal Code
117997
Country
Russian Federation
Facility Name
P.A. Herzen Oncological Inst. ; Oncology
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
Institut Catala d´Oncologia Hospital Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Insititut Catala D'Oncologia
City
Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08908
Country
Spain
Facility Name
Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
8208
Country
Spain
Facility Name
Hospital Universitario Reina Sofia; Servicio de Oncologia
City
Córdoba
State/Province
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Clinica Universitaria de Navarra; Servicio de Oncologia
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron; Oncology
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clínic i Provincial; Servicio de Oncología
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Hospital Ramon y Cajal; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Clinico San Carlos; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre; Servicio de Oncologia
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Inselspital Bern; Universitätsklinik für medizinische Onkologie
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Kantonsspital St. Gallen; Onkologie/Hämatologie
City
St. Gallen
ZIP/Postal Code
9007
Country
Switzerland
Facility Name
Taichung Veterans General Hospital; Division of Urology
City
Taichung
ZIP/Postal Code
407
Country
Taiwan
Facility Name
National Taiwan University Hospital, Department of Urology
City
Taipei
ZIP/Postal Code
10048
Country
Taiwan
Facility Name
TAIPEI VETERANS GENERAL HOSPITAL, Urology
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital-LinKou; Urology
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Royal Blackburn Hospital
City
Blackburn
ZIP/Postal Code
BB2 3HH
Country
United Kingdom
Facility Name
Leicester Royal Infirmary
City
Leicester
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
Barts and the London NHS Trust.
City
London
ZIP/Postal Code
EC1A 7BE
Country
United Kingdom
Facility Name
Sarah Cannon Research Institute
City
London
ZIP/Postal Code
W1G 6AD
Country
United Kingdom
Facility Name
The Christie NHS Foundation Trust
City
Manchester
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Royal Marsden Hospital; Institute of Cancer Research
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
35013615
Citation
Powles T, Yuen KC, Gillessen S, Kadel EE 3rd, Rathkopf D, Matsubara N, Drake CG, Fizazi K, Piulats JM, Wysocki PJ, Buchschacher GL Jr, Alekseev B, Mellado B, Karaszewska B, Doss JF, Rasuo G, Datye A, Mariathasan S, Williams P, Sweeney CJ. Atezolizumab with enzalutamide versus enzalutamide alone in metastatic castration-resistant prostate cancer: a randomized phase 3 trial. Nat Med. 2022 Jan;28(1):144-153. doi: 10.1038/s41591-021-01600-6. Epub 2022 Jan 10.
Results Reference
derived

Learn more about this trial

A Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Enzalutamide in Participants With Metastatic Castration-Resistant Prostrate Cancer (mCRPC) After Failure of an Androgen Synthesis Inhibitor And Failure of, Ineligibility For, or Refusal of a Taxane Regimen

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