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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-003092-22 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Atezolizumab + Enzalutamide | Experimental | 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). |
|
| Enzalutamide | Active Comparator | Participants will receive enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity (up to approximately 42 months). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atezolizumab | Drug | Atezolizumab will be administered at a fixed dose of 1200 milligrams (mg), intravenous (IV) infusion on Day 1 of each 21-day cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Overall Survival is defined as the time from randomization to death from any cause. | Baseline until death from any cause (up to approximately 42 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Survived at Month 6 and 12 | OS (Overall Survival is defined as the time from randomization to death from any cause) probability at 6 and 12 months | Months 6, 12 |
| Time to First Symptomatic Skeletal Event (SSE) |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Grp Inc. | Duarte | California | 91010 | United States | ||
| University of California San Diego |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35013615 | Derived | 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. |
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Total 759 participants were randomized.
Study was conducted at 155 centres in 21 countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | Atezolizumab + Enzalutamide | Participants received atezolizumab along with enzalutamide until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity. |
| FG001 | Enzalutamide |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 14, 2020 |
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| Enzalutamide | Drug | Enzalutamide capsules will be administered orally at a dose of 160 mg daily. |
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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.
| Baseline up to end of study (up to approximately 42 months) |
| 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:
| Baseline until disease progression or death from any cause (up to approximately 42 months) |
| 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:
| Months 6, 12 |
| 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 | Baseline until disease progression (up to approximately 42 months) |
| 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. | Baseline until disease progression (up to approximately 42 months) |
| 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 | Baseline until disease progression or death from any cause (up to approximately 42 months) |
| 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. | Baseline up to end of study (up to approximately 42 month) |
| Minimum Observed Serum Concentration (Cmin) of Atezolizumab | Safety visit-Discontinued participants had these visits within approximately 120 days after the last dosing; Study Completion Pre-dose visit-Participants had these visits at the last treatment dosing, samples were taken before the last dosing; Early Discontinuation Pre-dose visit-Participants who discontinued the study had these visits within the 30 days after their last dosing but samples were takes before their last dosing; Study Completion visit-Participants had these visits at their last treatment dosing but samples were taken after their last dosing; Early Discontinuation visit-Participants who discontinued the study had the visits within the 30 days after their last dosing but samples were taken after their last dosing; Unscheduled and Unscheduled Pre-dose Visits- At these visits, participants' samples were collected without dosing event and before dosing dosing at a visit unscheduled per protocol respectively. Enzalutamide Arm had no Atezolizumab dosing. | 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) |
| Maximum Observed Serum Concentration (Cmax) of Atezolizumab | Safety visit-Discontinued participants had these visits within approximately 120 days after the last dosing; Study Completion Pre-dose visit-Participants had these visits at the last treatment dosing, samples were taken before the last dosing; Early Discontinuation Pre-dose visit-Participants who discontinued the study had these visits within the 30 days after their last dosing but samples were takes before their last dosing; Study Completion visit-Participants had these visits at their last treatment dosing but samples were taken after their last dosing; Early Discontinuation visit-Participants who discontinued the study had the visits within the 30 days after their last dosing but samples were taken after their last dosing; Unscheduled and Unscheduled Pre-dose Visits- At these visits, participants' samples were collected without dosing event and before dosing dosing at a visit unscheduled per protocol respectively. Enzalutamide Arm had no Atezolizumab dosing. | Day Cycle 1 Day 1 0.5 hr post-infusion (infusion duration: 60 minutes [min]) |
| Plasma Concentration of Enzalutamide | Safety visit-Discontinued participants had these visits within approximately 120 days after the last dosing; Study Completion Pre-dose visit-Participants had these visits at the last treatment dosing, samples were taken before the last dosing; Early Discontinuation Pre-dose visit-Participants who discontinued the study had these visits within the 30 days after their last dosing but samples were takes before their last dosing; Study Completion visit-Participants had these visits at their last treatment dosing but samples were taken after their last dosing; Early Discontinuation visit-Participants who discontinued the study had the visits within the 30 days after their last dosing but samples were taken after their last dosing; Unscheduled and Unscheduled Pre-dose Visits- At these visits, participants' samples were collected without dosing event and before dosing dosing at a visit unscheduled per protocol respectively. Enzalutamide Arm had no Atezolizumab dosing. | 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 |
| Plasma Concentration of N-Desmethyl Enzalutamide | Safety visit-Discontinued participants had these visits within approximately 120 days after the last dosing; Study Completion Pre-dose visit-Participants had these visits at the last treatment dosing, samples were taken before the last dosing; Early Discontinuation Pre-dose visit-Participants who discontinued the study had these visits within the 30 days after their last dosing but samples were takes before their last dosing; Study Completion visit-Participants had these visits at their last treatment dosing but samples were taken after their last dosing; Early Discontinuation visit-Participants who discontinued the study had the visits within the 30 days after their last dosing but samples were taken after their last dosing; Unscheduled and Unscheduled Pre-dose Visits- At these visits, participants' samples were collected without dosing event and before dosing dosing at a visit unscheduled per protocol respectively. Enzalutamide Arm had no Atezolizumab dosing. | 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 |
| Number of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab | The numbers and proportions of ADA-positive participants and ADA-negative participants at baseline (baseline prevalence) and after baseline (post-baseline incidence) will be summarized by treatment group. Enzalutamide Arm has no Atezolizumab dosing therefore no participants to include here for Atezolizumab ADA. | 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 |
| La Jolla |
| California |
| 92037-1337 |
| United States |
| Kaiser Permanente San Diego - Los Angeles | Los Angeles | California | 90027 | United States |
| UC Irvine Medical Center | Orange | California | 92868 | United States |
| Pacific Hematology Oncology Associates | San Francisco | California | 94115 | United States |
| University of Colorado; Division of Medical Oncology | Aurora | Colorado | 80021 | United States |
| Yale School of Medicine | New Haven | Connecticut | 06510-3206 | United States |
| Stamford Hospital; BCC, MOHR | Stamford | Connecticut | 06904 | United States |
| Lynn Cancer Institute/Boca Raton Regional Hospital | Boca Raton | Florida | 33486 | United States |
| SCRI Florida Cancer Specialists South | Fort Myers | Florida | 33916 | United States |
| Miami Cancer Institute of Baptist Health, Inc. | Miami | Florida | 33176 | United States |
| Florida Cancer Specialist, North Region | St. Petersburg | Florida | 33705 | United States |
| Investigative Clin Rsch of IN | Indianapolis | Indiana | 46260 | United States |
| Associates in Oncology/Hematology P.C. | Rockville | Maryland | 20850 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| Karmanos Cancer Institute.. | Detroit | Michigan | 48201 | United States |
| Nebraska Cancer Specialists; Oncology Hematology West, PC | Omaha | Nebraska | 68130 | United States |
| Urology Cancer Center & GU Research Network | Omaha | Nebraska | 68130 | United States |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89128 | United States |
| MSKCC at Basking Ridge | Basking Ridge | New Jersey | 07920 | United States |
| New York Oncology Hematology, P.C. | Albany | New York | 12208 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | United States |
| Oncology Hematology Care, Inc. | Cincinnati | Ohio | 45230 | United States |
| James Cancer Hospital;Solove Research Institute | Columbus | Ohio | 43210 | United States |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| Allegheny Cancer Center | Pittsburgh | Pennsylvania | 15212 | United States |
| University of Pittsburgh Cancer Institute; Division of Medical Oncology | Pittsburgh | Pennsylvania | 15232 | United States |
| Miriam Hospital | Providence | Rhode Island | 02906 | United States |
| Charleston Oncology, P .A | Charleston | South Carolina | 29414 | United States |
| Carolina Urologic Research Center | Myrtle Beach | South Carolina | 29572 | United States |
| Sarah Cannon Research Institute / Tennessee Oncology | Chattanooga | Tennessee | 37404 | United States |
| Texas Oncology Cancer Center | Austin | Texas | 78731 | United States |
| Texas Oncology - Methodist Dallas Cancer Center | Dallas | Texas | 75203 | United States |
| Texas Oncology, P.A. - Fort Worth | Fort Worth | Texas | 76104 | United States |
| Texas Oncology - Memorial City | Houston | Texas | 77024 | United States |
| Texas Oncology-Tyler | Irving | Texas | 75063 | United States |
| Virginia Cancer Specialists - Alexandria | Alexandria | Virginia | 22304 | United States |
| Virginia Oncology Associates | Norfolk | Virginia | 23502 | United States |
| Eastern Health; Cancer Services | Box Hill | New South Wales | 3128 | Australia |
| Concord Repatriation General Hospital; Concord Cancer Centre | Concord | New South Wales | 2139 | Australia |
| Macquarie University Hospital | Macquarie Park | New South Wales | 2113 | Australia |
| Royal Brisbane & Women's Hosp; Cancer Care Serv | Herston | Queensland | 4029 | Australia |
| Adelaide Cancer Centre | Kurralta Park | South Australia | 5037 | Australia |
| Monash Medical Centre; Oncology | Clayton | Victoria | 3168 | Australia |
| LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie | Graz | 8036 | Austria |
| Ordensklinikum Linz Elisabethinen; Abteilung für Urologie und Andrologie | Linz | 4020 | Austria |
| Medizinische Universität Wien; Universitätsklinik für Urologie | Vienna | 1090 | Austria |
| Onze Lieve Vrouwziekenhuis Aalst | Aalst | 9300 | Belgium |
| UZ Gent | Ghent | 9000 | Belgium |
| CHU Sart-Tilman | Liège | 4000 | Belgium |
| Tom Baker Cancer Centre-Calgary | Calgary | Alberta | T2N 4N2 | Canada |
| Kingston General Hospital | Kingston | Ontario | K7L 2V7 | Canada |
| Lakeridge Health Oshawa; Oncology | Oshawa | Ontario | L1G 2B9 | Canada |
| Princess Margaret Cancer Center | Toronto | Ontario | M5G 1Z5 | Canada |
| Hopital Charles Lemoyne; Centre Integre de Lutte Contre Le Cancer de La Monteregie | Greenfield Park | Quebec | J4V 2H1 | Canada |
| Jewish General Hospital | Montreal | Quebec | H3T 1E2 | Canada |
| Centre Hospitalier Universitaire de Sherbrooke - Hopital Fleurimont | Sherbrooke | Quebec | J1H 5N4 | Canada |
| CHU de Québec - Université Laval - Hôtel-Dieu de Québec | Québec | G1J 1Z4 | Canada |
| Friendship Hospital, Capital Medical University | Beijing | 100050 | China |
| Jiangsu Cancer Hospital | Nanjing | 211100 | China |
| Zhongshan Hospital Fudan University | Shanghai | 200032 | China |
| Fudan University Shanghai Cancer Center | Shanghai | 200120 | China |
| Masarykuv onkologicky ustav | Brno | 656 53 | Czechia |
| Fakultni nemocnice u sv. Anny v Brne | Brno | 656 91 | Czechia |
| Thomayerova nemocnice | Praha 4 - Krc | 140 59 | Czechia |
| Aalborg Universitetshospital; Onkologisk Afdeling | Aalborg | 9000 | Denmark |
| Herlev Hospital; Afdeling for Kræftbehandling | Herlev | 2730 | Denmark |
| Odense Universitetshospital, Onkologisk Afdeling R | Odense C | 5000 | Denmark |
| Institut Sainte-Catherine; Oncologie | Avignon | 84082 | France |
| Centre Francois Baclesse; Oncologie | Caen | 14076 | France |
| Hopital Louis Pasteur; Medecine B | Colmar | 68024 | France |
| Centre Oscar Lambret; Chir Cancerologie General | Lille | 59000 | France |
| Clinique Chenieux; Oncology | Limoges | 87039 | France |
| Hopital Saint Louis, Service D Oncologie Medicale | Paris | 75475 | France |
| Hopital d'Instruction des Armees de Begin | Saint-Mandé | 94160 | France |
| Institut Claudius Regaud; Departement Oncologie Medicale | Toulouse | 31059 | France |
| Institut Gustave Roussy | Villejuif | 94805 | France |
| Universitätsklinikum Freiburg; Chirurgische Klinik; Abteilung Urologie | Freiburg im Breisgau | 79106 | Germany |
| Medizinische Hochschule Hannover; Klinik für Urologie und Onkologische Urologie | Hanover | 30625 | Germany |
| Universitätsklinikum Münster, Klinik für Urologie und Kinderurologie | Münster | 48149 | Germany |
| Universitätsklinikum Tübingen; Klinik für Urologie | Tübingen | 72076 | Germany |
| Urologisches Zentrum Euregio; Würselen, Urologische Praxis am Wasserturm | Würselen | 52146 | Germany |
| Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine | Athens | 115 22 | Greece |
| Alexandras Hospital; Dept. of Clin. Therapeutics, Athens Uni School of Medicine | Athens | 115 28 | Greece |
| Athens Medical Center; Dept. of Oncology | Athens | 151 25 | Greece |
| IASO General Hospital of Athens | Athens | 155 62 | Greece |
| Agioi Anargyroi Cancer Hospital; 2Nd Oncology Dept. | Kifissia | 145 64 | Greece |
| University Hospital of Patras Medical Oncology | Pátrai | 265 04 | Greece |
| Papageorgiou General Hospital; Medical Oncology | Thessaloniki | 564 29 | Greece |
| Semmelwies University of Medicine; Urology Dept. | Budapest | 1082 | Hungary |
| Orszagos Onkologiai Intezet; "C" Belgyógyászati-Onkológiai és Klinikai Farmakológiai Osztály | Budapest | 1122 | Hungary |
| Debreceni Egyetem Klinikai Kozpont ; Department of Oncology | Debrecen | 4032 | Hungary |
| Irccs Ist. Tumori Giovanni Paolo Ii; Dipartimento Oncologia Medica | Bari | Apulia | 70124 | Italy |
| IRCCS Ospedale Casa Sollievo Della Sofferenza; Oncologia | San Giovanni Rotondo | Apulia | 71013 | Italy |
| ISTITUTO NAZIONALE TUMORI IRCCS FONDAZIONE G. PASCALE; Dipartimento Uro-Ginecologico | Naples | Campania | 80131 | Italy |
| A.O. Universitaria Policlinico Di Modena; Oncologia | Modena | Emilia-Romagna | 41124 | Italy |
| Azienda Ospedaliera San Camillo Forlanini; Oncologia Medica | Rome | Lazio | 00152 | Italy |
| IRCCS AOU San Martino - IST; Oncologia Medica 1 | Genoa | Liguria | 16132 | Italy |
| A.O. Istituti Ospitalieri - Cremona; S.C. Oncologia | Cremona | Lombardy | 26100 | Italy |
| Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2 | Milan | Lombardy | 20133 | Italy |
| Irccs Istituto Europeo Di Oncologia (IEO); Cure Mediche | Milan | Lombardy | 20141 | Italy |
| Ospedale Area Aretina Nord; U.O.C. Oncologia | Arezzo | Tuscany | 52100 | Italy |
| IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Prima | Padova | Veneto | 35128 | Italy |
| Nagoya City University Hospital | Aichi | 467-8602 | Japan |
| National Cancer Center East | Chiba | 277-8577 | Japan |
| Toho University Sakura Medical Center | Chiba | 285-8741 | Japan |
| Kyushu University Hospital | Fukuoka | 812-8582 | Japan |
| National Hospital Organization Hokkaido Cancer Center | Hokkaido | 003-0804 | Japan |
| Yokohama City University Medical Center | Kanagawa | 232-0024 | Japan |
| Kitasato University Hospital | Kanagawa | 252-0375 | Japan |
| University Hospital Kyoto Prefectural University of Medicine | Kyoto | 602-8566 | Japan |
| Nara Medical University Hospital | Nara | 634-8522 | Japan |
| Niigata University Medical & Dental Hospital | Niigata | 951-8520 | Japan |
| Kansai Medical University Hospital | Osaka | 573-1191 | Japan |
| Toranomon Hospital | Tokyo | 105-8470 | Japan |
| The Jikei University Hospital | Tokyo | 105-8471 | Japan |
| Nippon Medical School Hospital | Tokyo | 113-8603 | Japan |
| Woj. Wielospec. Centrum Onkologii i Traumatologii | ?ód? | 93-513 | Poland |
| Medical University of Bialystok; Oncology clinic | Bialystok | 15-027 | Poland |
| Przychodnia Lekarska KOMED, Roman Karaszewski | Konin | 62-500 | Poland |
| Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii | Krakow | 30-688 | Poland |
| SPZOZ Opolskie Centrum Onkologii im. Prof. Tadeusza Koszarawskiego | Opole | 45-061 | Poland |
| Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii | Otwock | 05-400 | Poland |
| Szpital Sw. Elzbiety - Mokotowskie Centrum Medyczne Sp. z o.o. | Warsaw | 02-616 | Poland |
| Wojewodzki Szpital; Specjalistyczny ul. | Wroclaw | 51-124 | Poland |
| Russian Scientific Center of Roentgenoradiology | Moscow | Moscow Oblast | 117997 | Russia |
| P.A. Herzen Oncological Inst. ; Oncology | Moscow | Moscow Oblast | 125248 | Russia |
| SBEI HPE "The First St.Petersburg State Medical University n.a. acad. I.P.Pavlova"of MoH of RF | Saint Petersburg | Sankt-Peterburg | 197022 | Russia |
| National Cancer Center | Goyang-si | 10408 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Institut Catala d?Oncologia Hospital Germans Trias i Pujol | Badalona | Barcelona | 08916 | Spain |
| Insititut Catala D'Oncologia | L'Hospitalet de Llobregat | Barcelona | 08908 | Spain |
| Corporacio Sanitaria Parc Tauli; Servicio de Oncologia | Sabadell | Barcelona | 8208 | Spain |
| Hospital Universitario Reina Sofia; Servicio de Oncologia | Córdoba | Cordoba | 14004 | Spain |
| Clinica Universitaria de Navarra; Servicio de Oncologia | Pamplona | Navarre | 31008 | Spain |
| Hospital Universitari Vall d'Hebron; Oncology | Barcelona | 08035 | Spain |
| Hospital Clínic i Provincial; Servicio de Oncología | Barcelona | 08036 | Spain |
| Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia | Barcelona | 08041 | Spain |
| Hospital Ramon y Cajal; Servicio de Oncologia | Madrid | 28034 | Spain |
| Hospital Clinico San Carlos; Servicio de Oncologia | Madrid | 28040 | Spain |
| Hospital Universitario 12 de Octubre; Servicio de Oncologia | Madrid | 28041 | Spain |
| Hospital Clinico Universitario Virgen de la Victoria; Servicio de Oncologia | Málaga | 29010 | Spain |
| Hospital Universitario Virgen del Rocio; Servicio de Oncologia | Seville | 41013 | Spain |
| Inselspital Bern; Universitätsklinik für Medizinische Onkologie, Klinische Forschungseinheit | Bern | 3010 | Switzerland |
| Kantonsspital St. Gallen; Onkologie/Hämatologie | Sankt Gallen | 9007 | Switzerland |
| Taichung Veterans General Hospital; Division of Urology | Taichung | 407 | Taiwan |
| National Taiwan University Hospital, Department of Urology | Taipei | 10048 | Taiwan |
| TAIPEI VETERANS GENERAL HOSPITAL, Urology | Taipei | 11217 | Taiwan |
| Chang Gung Memorial Hospital-LinKou; Urology | Taoyuan | 333 | Taiwan |
| Royal Blackburn Hospital | Blackburn | BB2 3HH | United Kingdom |
| Leicester Royal Infirmary | Leicester | LE1 5WW | United Kingdom |
| Barts and the London NHS Trust. | London | EC1A 7BE | United Kingdom |
| Sarah Cannon Research Institute | London | W1G 6AD | United Kingdom |
| The Christie NHS Foundation Trust | Manchester | M20 4BX | United Kingdom |
| Royal Marsden Hospital; Institute of Cancer Research | Sutton | SM2 5PT | United Kingdom |
Participants received enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.
| Participants Received Treatment |
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| COMPLETED |
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| NOT COMPLETED |
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Total randomised participants 759.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Atezolizumab + Enzalutamide | Participants received atezolizumab along with enzalutamide until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity. |
| BG001 | Enzalutamide | Participants received enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Overall Survival (OS) | Overall Survival is defined as the time from randomization to death from any cause. | The intent-to-treat (ITT) population is defined as all randomized participants regardless of whether the assigned study treatment was received. For efficacy analyses, participants were analyzed according to their randomized treatment assignment. Here, "Number Analyzed" refers to number of participants from whom data was collected and analyzed. | Posted | Median | 95% Confidence Interval | Months | Baseline until death from any cause (up to approximately 42 months) |
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| Secondary | Percentage of Participants Who Survived at Month 6 and 12 | OS (Overall Survival is defined as the time from randomization to death from any cause) probability at 6 and 12 months | The intent-to-treat (ITT) population is defined as all randomized participants regardless of whether the assigned study treatment was received. For efficacy analyses, participants were analyzed according to their randomized treatment assignment. Here, "Number Analyzed" refers to number of participants from whom data was collected and analyzed. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Months 6, 12 |
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| Secondary | 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. | The intent-to-treat (ITT) population is defined as all randomized participants regardless of whether the assigned study treatment was received. For efficacy analyses, participants were analyzed according to their randomized treatment assignment. Here, "Number Analyzed" refers to number of participants from whom data was collected and analyzed. | Posted | Median | 95% Confidence Interval | Months | Baseline up to end of study (up to approximately 42 months) |
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| Secondary | 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:
| The intent-to-treat (ITT) population is defined as all randomized participants regardless of whether the assigned study treatment was received. For efficacy analyses, participants were analyzed according to their randomized treatment assignment. Here, "Number Analyzed" refers to number of participants from whom data was collected and analyzed. | Posted | Median | 95% Confidence Interval | Months | Baseline until disease progression or death from any cause (up to approximately 42 months) |
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| Secondary | 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:
| The intent-to-treat (ITT) population is defined as all randomized participants regardless of whether the assigned study treatment was received. For efficacy analyses, participants were analyzed according to their randomized treatment assignment. Here, "Number Analyzed" refers to number of participants from whom data was collected and analyzed. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Months 6, 12 |
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| Secondary | 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 | The intent-to-treat (ITT) population is defined as all randomized participants regardless of whether the assigned study treatment was received. For efficacy analyses, participants were analyzed according to their randomized treatment assignment. Here, "Number Analyzed" refers to number of participants from whom data was collected and analyzed. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Baseline until disease progression (up to approximately 42 months) |
|
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| Secondary | 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. | The intent-to-treat (ITT) population is defined as all randomized participants regardless of whether the assigned study treatment was received. For efficacy analyses, participants were analyzed according to their randomized treatment assignment. Here, "Number Analyzed" refers to number of participants in the ITT population with measurable soft tissue lesions at baseline. | Posted | Median | 95% Confidence Interval | Months | Baseline until disease progression (up to approximately 42 months) |
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| Secondary | 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 |
| Posted | Number | 95% Confidence Interval | Percentage of Participants | Baseline until disease progression or death from any cause (up to approximately 42 months) |
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| Secondary | 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. | The safety population is defined as participants who received any amount of any component of the study treatments (atezolizumab, or enzalutamide). Participants will be allocated to treatment arms according to the treatment they actually received (i.e., participants randomized to enzalutamide alone who received at least one full or partial dose of atezolizumab will be included in the atezolizumab arm for safety) | Posted | Number | Percentage of Participants | Baseline up to end of study (up to approximately 42 month) |
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| Secondary | Minimum Observed Serum Concentration (Cmin) of Atezolizumab | Safety visit-Discontinued participants had these visits within approximately 120 days after the last dosing; Study Completion Pre-dose visit-Participants had these visits at the last treatment dosing, samples were taken before the last dosing; Early Discontinuation Pre-dose visit-Participants who discontinued the study had these visits within the 30 days after their last dosing but samples were takes before their last dosing; Study Completion visit-Participants had these visits at their last treatment dosing but samples were taken after their last dosing; Early Discontinuation visit-Participants who discontinued the study had the visits within the 30 days after their last dosing but samples were taken after their last dosing; Unscheduled and Unscheduled Pre-dose Visits- At these visits, participants' samples were collected without dosing event and before dosing dosing at a visit unscheduled per protocol respectively. Enzalutamide Arm had no Atezolizumab dosing. | PK evaluable population. This population is defined as all randomized participants regardless of whether the assigned study treatment was received. For PK analyses, participants were analyzed according to their randomized treatment assignment. Here, "Number Analyzed" refers to number of participants from whom data was collected and analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram/mL | 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) |
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| Secondary | Maximum Observed Serum Concentration (Cmax) of Atezolizumab | Safety visit-Discontinued participants had these visits within approximately 120 days after the last dosing; Study Completion Pre-dose visit-Participants had these visits at the last treatment dosing, samples were taken before the last dosing; Early Discontinuation Pre-dose visit-Participants who discontinued the study had these visits within the 30 days after their last dosing but samples were takes before their last dosing; Study Completion visit-Participants had these visits at their last treatment dosing but samples were taken after their last dosing; Early Discontinuation visit-Participants who discontinued the study had the visits within the 30 days after their last dosing but samples were taken after their last dosing; Unscheduled and Unscheduled Pre-dose Visits- At these visits, participants' samples were collected without dosing event and before dosing dosing at a visit unscheduled per protocol respectively. Enzalutamide Arm had no Atezolizumab dosing. | PK evaluable population. This population is defined as all randomized participants regardless of whether the assigned study treatment was received. For PK analyses, participants were analyzed according to their randomized treatment assignment. Here, "Number Analyzed" refers to number of participants from whom data was collected and analyzed. | Posted | Geometric Mean | Geometric Coefficient of Variation | Microgram/mL | Day Cycle 1 Day 1 0.5 hr post-infusion (infusion duration: 60 minutes [min]) |
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| Secondary | Plasma Concentration of Enzalutamide | Safety visit-Discontinued participants had these visits within approximately 120 days after the last dosing; Study Completion Pre-dose visit-Participants had these visits at the last treatment dosing, samples were taken before the last dosing; Early Discontinuation Pre-dose visit-Participants who discontinued the study had these visits within the 30 days after their last dosing but samples were takes before their last dosing; Study Completion visit-Participants had these visits at their last treatment dosing but samples were taken after their last dosing; Early Discontinuation visit-Participants who discontinued the study had the visits within the 30 days after their last dosing but samples were taken after their last dosing; Unscheduled and Unscheduled Pre-dose Visits- At these visits, participants' samples were collected without dosing event and before dosing dosing at a visit unscheduled per protocol respectively. Enzalutamide Arm had no Atezolizumab dosing. | PK evaluable population | Posted | Geometric Mean | Geometric Coefficient of Variation | Microgram/mL | 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 |
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| Secondary | Plasma Concentration of N-Desmethyl Enzalutamide | Safety visit-Discontinued participants had these visits within approximately 120 days after the last dosing; Study Completion Pre-dose visit-Participants had these visits at the last treatment dosing, samples were taken before the last dosing; Early Discontinuation Pre-dose visit-Participants who discontinued the study had these visits within the 30 days after their last dosing but samples were takes before their last dosing; Study Completion visit-Participants had these visits at their last treatment dosing but samples were taken after their last dosing; Early Discontinuation visit-Participants who discontinued the study had the visits within the 30 days after their last dosing but samples were taken after their last dosing; Unscheduled and Unscheduled Pre-dose Visits- At these visits, participants' samples were collected without dosing event and before dosing dosing at a visit unscheduled per protocol respectively. Enzalutamide Arm had no Atezolizumab dosing. | PK evaluable population | Posted | Geometric Mean | Geometric Coefficient of Variation | Microgram/mL | 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 |
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| Secondary | Number of Participants With Anti-Drug Antibodies (ADAs) to Atezolizumab | The numbers and proportions of ADA-positive participants and ADA-negative participants at baseline (baseline prevalence) and after baseline (post-baseline incidence) will be summarized by treatment group. Enzalutamide Arm has no Atezolizumab dosing therefore no participants to include here for Atezolizumab ADA. | The safety population is defined as participants who received any amount of any component of the study treatments (atezolizumab, or enzalutamide). Participants will be allocated to treatment arms according to the treatment they actually received (i.e., participants randomized to enzalutamide alone who received at least one full or partial dose of atezolizumab will be included in the atezolizumab arm for safety). | Posted | Count of Participants | Participants | 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 |
|
From Baseline Up To 4 Years 11 Months. For outcome measures and ADA measurements, the time frame was up to 42 (3 years and 6 months) months. However for Adverse Events, the duration of the timeframe was 4 years 11 month. The study was terminated earlier than the planned date and stopped for the efficacy outcomes. And participants' safety was followed up for longer time period.
4 participants in Atezolizumab + Enzalutamide Arm and 5 participants in Enzalutamide Arm were excluded from the Safety Evaluated Population as they did not receive the study treatment.
The Safety Evaluated Population comprised with 750 participants (375 and 375 in both arms respectively).
759 participants who were randomized are included in the At Risk Population for All Cause Mortality.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Atezolizumab + Enzalutamide | Participants received atezolizumab along with enzalutamide until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity. | 219 | 379 | 139 | 374 | 339 | 374 |
| EG001 | Enzalutamide | Participants received enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity. | 191 | 380 | 87 | 376 | 309 | 376 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Heparin-induced thrombocytopenia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Autoimmune myocarditis | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Cardiac disorder | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Cardiovascular insufficiency | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Left ventricular failure | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Myocarditis | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Ventricular fibrillation | Cardiac disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Deafness unilateral | Ear and labyrinth disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Adrenal insufficiency | Endocrine disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Uveitis | Eye disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Diverticular perforation | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Gastroduodenal ulcer | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Complication of device insertion | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Necrosis | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hepatitis | Hepatobiliary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Encephalitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Infected cyst | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Nosocomial infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Pneumonia legionella | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Spinal cord infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Superinfection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Jaw fracture | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Lower limb fracture | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Multiple injuries | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Troponin increased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Haemarthrosis | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pathological fracture | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Torticollis | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| Tumour rupture | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.0 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Cranial nerve palsies multiple | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| IIIrd nerve paralysis | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Lacunar infarction | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Myasthenic syndrome | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Paralysis | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Paraparesis | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hydrothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypercapnia | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Erythema multiforme | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Stevens-Johnson syndrome | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Bladder neoplasm surgery | Surgical and medical procedures | MedDRA 22.0 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pelvic venous thrombosis | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Peripheral artery thrombosis | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Myelosuppression | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Papilloedema | Eye disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Unevaluable event | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypertransaminasaemia | Hepatobiliary disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Postoperative abscess | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Injury | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
| |
| Nephritis | Renal and urinary disorders | MedDRA 22.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 22.0 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 22.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 22.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 22.0 | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 | genentech@druginfo.com |
| Apr 5, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D064129 | Prostatic Neoplasms, Castration-Resistant |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000594389 | atezolizumab |
| C540278 | enzalutamide |
Not provided
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 0.2786 |
| Hazard Ratio (HR) |
| 1.118 |
| 2-Sided |
| 95 |
| 0.913 |
| 1.370 |
| Superiority |
|
|
| Units | Counts |
|---|
| Participants |
|
|
| OG001 | Enzalutamide | Participants received enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity. |
|
|
|
| OG001 | Enzalutamide | Participants received enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity. |
|
|
|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Participants |
|
|
|
|
| OG001 | Enzalutamide | Participants received enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity. |
|
|
| OG001 | Enzalutamide | Participants received enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity. |
|
|
Participants received enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.
|
|
Participants received enzalutamide alone until investigator-assessed confirmed radiographic disease progression per PCWG3 criteria or unacceptable toxicity.
|
|
|
|