Prostatic Neoplasms Clinical Trial
Official title:
A Phase 3, Randomized, Double-blind Study of Pembrolizumab (MK-3475) Plus Docetaxel Plus Prednisone Versus Placebo Plus Docetaxel Plus Prednisone in Participants With Chemotherapy-naïve Metastatic Castration-Resistant Prostate Cancer (mCRPC) Who Have Progressed on a Next Generation Hormonal Agent (NHA) (KEYNOTE-921)
| Verified date | August 2023 |
| Source | Merck Sharp & Dohme LLC |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to assess the efficacy and safety of the combination of pembrolizumab (MK-3475) and docetaxel in the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy for mCRPC but have progressed on or are intolerant to Next Generation Hormonal Agent (NHA). There are two primary study hypotheses. Hypothesis 1: The combination of pembrolizumab plus docetaxel plus prednisone is superior to placebo plus docetaxel plus prednisone with respect to Overall Survival (OS). Hypothesis 2: The combination of pembrolizumab plus docetaxel plus prednisone is superior to placebo plus docetaxel plus prednisone with respect to Radiographic Progression-free Survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by blinded independent central review.
| Status | Completed |
| Enrollment | 1030 |
| Est. completion date | July 18, 2023 |
| Est. primary completion date | June 20, 2022 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 18 Years and older |
| Eligibility | The main inclusion and exclusion criteria include but are not limited to the following: Inclusion Criteria: - Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology - Has prostate cancer progression while on androgen deprivation therapy (or post bilateral orchiectomy) within 6 months prior to screening - Has current evidence of metastatic disease documented by either bone lesions on bone scan and/or soft tissue disease by computed tomography/magnetic resonance imaging (CT/MRI) - Has received prior treatment with one (but not more than one) NHA (eg, abiraterone acetate, enzalutamide, apalutamide, or darolutamide) for metastatic hormone-sensitive prostate cancer (mHSPC) or castration-resistant prostate cancer (CRPC) and either a) progressed through treatment OR b) has become intolerant of the drug - Has ongoing androgen deprivation with serum testosterone <50 ng/dL (<2.0 nM) - Participants receiving bone resorptive therapy (including, but not limited to, bisphosphonate or denosumab) must have been on stable doses prior to randomization - Participants must agree to the following during the study treatment period and for at least 120 days after the last dose of pembrolizumab or for at least 180 days after the last dose of docetaxel (whichever is longer): Refrain from donating sperm PLUS Use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause) - Participants must agree to use male condom when engaging in any activity that allows for passage of ejaculate to another person of any sex - Has provided newly obtained core or excisional biopsy (obtained within 12 months of screening) from soft tissue not previously irradiated (samples from tumors progressing in a prior site of radiation are allowed). Participants with bone only or bone predominant disease may provide a bone biopsy sample - Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days of randomization Exclusion Criteria: - Has a known additional malignancy that is progressing or has required active treatment in the last 3 years - Has an active autoimmune disease that has required systemic treatment in past 2 years - Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy - Has undergone major surgery including local prostate intervention (excluding prostate biopsy) within 28 days prior to randomization and not recovered adequately from the toxicities and/or complications - Has a gastrointestinal disorder affecting absorption or is unable to swallow tablets/capsules - Has an active infection (including tuberculosis) requiring systemic therapy - Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis - Has known active human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection - Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis - Has severe hypersensitivity (=Grade 3) to pembrolizumab and/or any of its excipients - Has symptomatic congestive heart failure (New York Heart Association Class III or IV heart disease) - Has had a prior anti-cancer monoclonal antibody (mAb) prior to randomization or who has not recovered (i.e., Grade =1 or at baseline) from AEs due to mAbs - Has used herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA levels (e.g. saw palmetto) prior to randomization - Has received prior treatment with radium or other therapeutic radiopharmaceuticals for prostate cancer - Has received prior therapy with an anti-programmed cell death-1 (anti-PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1), or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX-40, CD137) - Has received prior treatment with docetaxel or another chemotherapy agent for mCRPC - Has hypersensitivity to docetaxel or polysorbate 80 - Is currently receiving either strong or moderate inhibitors of cytochrome P450 (CYP)3A4 that cannot be discontinued for the duration of the study - Has received prior targeted small molecule therapy or abiraterone acetate, enzalutamide, apalutamide, or darolutamide within 4 weeks prior to the first dose of study treatment, or has not recovered (i.e., Grade =1 or at baseline) from AEs due to a previously administered agent - Has received prior radiotherapy to within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis - Has received a live vaccine within 30 days prior to randomization - Has received treatment with 5a reductase inhibitors (eg, finasteride or dutasteride), estrogens, and/or cyproterone within 4 weeks prior to randomization - Has received prior treatment with ketoconazole for prostate cancer - Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment - Has a "superscan" bone scan - Is expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study treatment - Has had an allogenic tissue/solid organ transplant |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 1013) | Berazategui | Buenos Aires |
| Argentina | Centro de Diagnostico Urologico ( Site 1008) | Buenos Aires | Caba |
| Argentina | Hospital Aleman ( Site 1004) | Buenos Aires | |
| Argentina | Hospital Britanico de Buenos Aires ( Site 1006) | Buenos Aires | Caba |
| Argentina | Instituto de Investigaciones Metabolicas [Buenos Aires, Argentina] ( Site 1011) | Buenos Aires | |
| Argentina | Instituto Medico Alexander Fleming ( Site 1010) | Buenos Aires | |
| Argentina | CEMAIC ( Site 1014) | Cordoba | |
| Argentina | Instituto de Investigaciones Clinicas ( Site 1000) | Mar del Plata | Buenos Aires |
| Argentina | Sanatorio Parque ( Site 1002) | Rosario | Santa Fe |
| Australia | St George Hospital ( Site 0157) | Kogarah | New South Wales |
| Australia | Macquarie University ( Site 0151) | Macquarie University | New South Wales |
| Australia | Hollywood Private Hospital ( Site 0163) | Nedlands | Western Australia |
| Australia | Port Macquarie Base Hospital ( Site 0153) | Port Macquarie | New South Wales |
| Australia | Redcliffe Hospital ( Site 0161) | Redcliffe | Queensland |
| Australia | John Flynn Hospital & Medical Centre ( Site 0164) | Tugun | Queensland |
| Australia | Calvary Mater Newcastle ( Site 0148) | Waratah | New South Wales |
| Austria | Medizinische Universitat Graz ( Site 0374) | Graz | Steiermark |
| Austria | Ordensklinikum Linz GmbH Elisabethinen ( Site 0373) | Linz | Oberosterreich |
| Austria | SCRI-CCCIT GesmbH ( Site 0371) | Salzburg | |
| Austria | Medizinische Universitaet Wien ( Site 0375) | Wien | |
| Brazil | Hospital de Caridade de Ijui ( Site 1038) | Ijui | Rio Grande Do Sul |
| Brazil | Centro de Novos Tratamentos Itajai - Clinica de Neoplasias Litoral ( Site 1035) | Itajai | Santa Catarina |
| Brazil | Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 1021) | Porto Alegre | Rio Grande Do Sul |
| Brazil | Hospital de Base de Sao Jose de Rio Preto ( Site 1022) | Sao Jose do Rio Preto | Sao Paulo |
| Brazil | A.C. Camargo Cancer Center ( Site 1026) | Sao Paulo | |
| Canada | Nova Scotia Health Authority QEII-HSC ( Site 0114) | Halifax | Nova Scotia |
| Canada | Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0116) | Hamilton | Ontario |
| Canada | Grand River Hospital ( Site 0120) | Kitchener | Ontario |
| Canada | Lakeridge Health ( Site 0117) | Oshawa | Ontario |
| Canada | CHU de Quebec-Universite Laval-Hotel Dieu de Quebec ( Site 0103) | Quebec | |
| Canada | CIUSSS du Bas Saint Laurent - Hopital Regional de Rimouski ( Site 0102) | Rimouski | Quebec |
| Canada | CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0105) | Sherbrooke | Quebec |
| Canada | Princess Margaret Cancer Centre ( Site 0107) | Toronto | Ontario |
| Canada | Sunnybrook Research Institute ( Site 0108) | Toronto | Ontario |
| Chile | Bradford Hill Centro de Investigaciones Clinicas ( Site 1044) | Santiago | Region M. De Santiago |
| Chile | Fundacion Arturo Lopez Perez ( Site 1049) | Santiago | Region M. De Santiago |
| Chile | Pontificia Universidad Catolica de Chile ( Site 1047) | Santiago | Region M. De Santiago |
| Chile | Centro Investigación del Cáncer James Lind ( Site 1041) | Temuco | Araucania |
| Chile | Rey y Oreilly Limitada ( Site 1048) | Temuco | Araucania |
| Chile | Centro de Investigaciones Clinicas Vina del Mar ( Site 1042) | Vina del Mar | Valparaiso |
| China | Beijing Cancer Hospital ( Site 1305) | Beijing | Beijing |
| China | Peking University First Hospital ( Site 1303) | Beijing | Beijing |
| China | The Fifth Medical Center of PLA General Hospital ( Site 1307) | Beijing | Beijing |
| China | Hunan Cancer Hospital ( Site 1320) | Changsha | Hunan |
| China | Sun Yat Sen Memorial Hospital ( Site 1323) | Guangzhou | Guangdong |
| China | The First Affiliated Hospital of Guangzhou Medical University ( Site 1330) | Guangzhou | Guangdong |
| China | The Second Affiliated Hospital of Zhejiang University School of Medicine ( Site 1309) | Hangzhou | Zhejiang |
| China | Zhejiang Provincial People's Hospital ( Site 1310) | Hangzhou | Zhejiang |
| China | Harbin Medical University Cancer Hospital ( Site 1326) | Harbin | Heilongjiang |
| China | Nanjing Drum Tower Hospital ( Site 1312) | Nanjing | Jiangsu |
| China | Fudan University Shanghai Cancer Center ( Site 1300) | Shanghai | Shanghai |
| China | Zhongshan Hospital Fudan University ( Site 1301) | Shanghai | Shanghai |
| China | Hubei Cancer Hospital ( Site 1329) | Wuhan | Hubei |
| China | The First Affiliated Hospital of Xiamen University ( Site 1319) | Xiamen | Fujian |
| China | Henan Cancer Hospital ( Site 1321) | Zhengzhou | Henan |
| Colombia | Biomelab S A S ( Site 1067) | Barranquilla | Atlantico |
| Colombia | Clinica de la Costa Ltda. ( Site 1073) | Barranquilla | Atlantico |
| Colombia | Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 1062) | Bogota | Distrito Capital De Bogota |
| Colombia | Instituto Nacional de Cancerologia E.S.E ( Site 1061) | Bogota | Distrito Capital De Bogota |
| Colombia | Centro Medico Imbanaco de Cali S.A ( Site 1064) | Cali | Valle Del Cauca |
| Colombia | Hemato Oncologos S.A. ( Site 1065) | Cali | Valle Del Cauca |
| Colombia | Hospital Pablo Tobon Uribe ( Site 1066) | Medellin | Antioquia |
| Colombia | Oncomedica S.A. ( Site 1057) | Monteria | Cordoba |
| Colombia | Oncologos del Occidente S.A. ( Site 1072) | Pereira | Risaralda |
| Colombia | Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 1068) | Valledupar | Cesar |
| France | CHU Amiens Picardie Site Sud Amiens ( Site 0438) | Amiens | Somme |
| France | Institut Sainte Catherine ( Site 0447) | Avignon | Vaucluse |
| France | CHU Jean Minjoz ( Site 0423) | Besancon | Doubs |
| France | Institut Bergonie ( Site 0421) | Bordeaux | Gironde |
| France | CHU de Brest -Site Hopital Morvan ( Site 0441) | Brest | Finistere |
| France | Centre Jean Perrin ( Site 0434) | Clermont-Ferrand | Auvergne |
| France | Centre Leon Berard ( Site 0422) | Lyon | Auvergne |
| France | Institut Paoli Calmettes. ( Site 0419) | Marseille | Bouches-du-Rhone |
| France | Centre D Oncologie de Gentilly ( Site 0432) | Nancy | Meurthe-et-Moselle |
| France | Centre Hospitalier Regional du Orleans ( Site 0430) | Orleans | Loiret |
| France | Institut Mutualiste Montsouris ( Site 0446) | Paris | |
| France | C.H.U. Lyon Sud ( Site 0436) | Pierre Benite | Rhone |
| France | Institut De Cancerologie De L Ouest ( Site 0448) | Saint Herblain | Loire-Atlantique |
| France | C.H. de Saint Quentin ( Site 0481) | Saint Quentin | Aisne |
| France | Clinique Sainte Anne ( Site 0431) | Strasbourg | Alsace |
| France | Hopital Foch ( Site 0428) | Suresnes | Hauts-de-Seine |
| France | Institut Claudius Regaud IUCT Oncopole ( Site 0418) | Toulouse | Haute-Garonne |
| France | Institut Gustave Roussy ( Site 0416) | Villejuif | Val-de-Marne |
| Germany | Uniklinik RWTH Aachen ( Site 0308) | Aachen | Nordrhein-Westfalen |
| Germany | Charite Universitaetsmedizin Berlin ( Site 0301) | Berlin | |
| Germany | Universitaetsklinikum Freiburg - Medizinische Klinik ( Site 0304) | Freiburg | Baden-Wurttemberg |
| Germany | Universitaetsklinikum Goettingen ( Site 0345) | Goettingen | Niedersachsen |
| Germany | Universitaetsklinikum des Saarlandes ( Site 0348) | Homburg | Saarland |
| Germany | Universitaetsklinikum Jena ( Site 0305) | Jena | Thuringen |
| Germany | Universitaetsklinikum in Mannheim ( Site 0314) | Mannheim | Baden-Wurttemberg |
| Germany | Klinikum Rechts der Isar ( Site 0300) | Muenchen | Bayern |
| Germany | Universitaetsklinik der Paracelsus Medizinischen Privatuniversitaet ( Site 0318) | Nuernberg | Bayern |
| Germany | Studienpraxis Urologie ( Site 0309) | Nuertingen | Baden-Wurttemberg |
| Germany | Universitaetsklinik fuer Urologie ( Site 0307) | Tuebingen | Baden-Wurttemberg |
| Germany | Universitaetsklinikum Wuerzburg ( Site 0302) | Wuerzburg | Bayern |
| Ireland | Cork University Hospital ( Site 0727) | Cork | |
| Ireland | Tallaght University Hospital ( Site 0730) | Dublin | |
| Ireland | Mid Western Cancer Centre ( Site 0728) | Limerick | |
| Israel | Soroka Medical Center ( Site 0548) | Beer Sheva | |
| Israel | Assaf Harofeh MC ( Site 0547) | Beer Yaakov-Zerifin | |
| Israel | Rambam Medical Center ( Site 0543) | Haifa | |
| Israel | Hadassah Ein Kerem Medical Center ( Site 0546) | Jerusalem | |
| Israel | Meir Medical Center ( Site 0544) | Kfar Saba | |
| Israel | Rabin Medical Center ( Site 0545) | Petach-Tikwa | |
| Israel | Chaim Sheba Medical Center ( Site 0541) | Ramat Gan | |
| Israel | Sourasky Medical Center ( Site 0542) | Tel Aviv | |
| Italy | Azienda Ospedaliera Cannizzaro ( Site 0458) | Catania | |
| Italy | A.O. Universitaria di Modena ( Site 0454) | Modena | |
| Italy | Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 0457) | Napoli | |
| Italy | Azienda Ospedaliera San Camillo Forlanini ( Site 0455) | Roma | |
| Italy | Istituto Clinico Humanitas Research Hospital ( Site 0452) | Rozzano | Milano |
| Italy | Azienda Ospedaliera Santa Maria Terni ( Site 0456) | Terni | |
| Italy | Presidio Ospedaliero Santa Chiara ( Site 0451) | Trento | |
| Japan | Chiba Cancer Center ( Site 0704) | Chiba | |
| Japan | Kyushu University Hospital ( Site 0718) | Fukuoka | |
| Japan | Hamamatsu University Hospital ( Site 0720) | Hamamatsu | Shizuoka |
| Japan | Saitama Medical University International Medical Center ( Site 0708) | Hidaka | Saitama |
| Japan | Kanazawa University Hospital ( Site 0701) | Kanazawa | Ishikawa |
| Japan | Nara Medical University Hospital ( Site 0715) | Kashihara | Nara |
| Japan | National Cancer Center Hospital East ( Site 0702) | Kashiwa | Chiba |
| Japan | Dokkyo Medical University Saitama Medical Center ( Site 0707) | Koshigaya | Saitama |
| Japan | National Hospital Organization Shikoku Cancer Center ( Site 0716) | Matsuyama | Ehime |
| Japan | University of Miyazaki Hospital ( Site 0721) | Miyazaki | |
| Japan | Nagasaki University Hospital ( Site 0719) | Nagasaki | |
| Japan | Kindai University Hospital ( Site 0714) | Osakasayama | Osaka |
| Japan | Kitasato University Hospital ( Site 0705) | Sagamihara | Kanagawa |
| Japan | Toho University Sakura Medical Center ( Site 0703) | Sakura | Chiba |
| Japan | Osaka University Hospital ( Site 0713) | Suita | Osaka |
| Japan | Keio University Hospital ( Site 0710) | Tokyo | |
| Japan | Nippon Medical School Hospital ( Site 0709) | Tokyo | |
| Japan | Toranomon Hospital ( Site 0711) | Tokyo | |
| Japan | Yamaguchi University Hospital ( Site 0717) | Ube | Yamaguchi |
| Japan | Yokohama City University Medical Center ( Site 0706) | Yokohama | Kanagawa |
| Korea, Republic of | National Cancer Center ( Site 0174) | Goyang-si | Kyonggi-do |
| Korea, Republic of | Seoul National University Bundang Hospital ( Site 0175) | Seongnam-si | Kyonggi-do |
| Korea, Republic of | Asan Medical Center ( Site 0176) | Seoul | |
| Korea, Republic of | Samsung Medical Center ( Site 0172) | Seoul | |
| Korea, Republic of | Seoul National University Hospital ( Site 0171) | Seoul | |
| Netherlands | Antoni van Leeuwenhoek Ziekenhuis ( Site 0480) | Amsterdam | Noord-Holland |
| Netherlands | Reinier de Graaf Groep ( Site 0484) | Delft | Zuid-Holland |
| Netherlands | Jeroen Bosch Ziekenhuis ( Site 1200) | Den Bosch | Noord-Brabant |
| Netherlands | Hagaziekenhuis ( Site 1201) | Den Haag | Zuid-Holland |
| Netherlands | Ziekenhuis Gelderse Vallei ( Site 0485) | Ede | Gelderland |
| Netherlands | Catharina Ziekenhuis ( Site 0472) | Eindhoven | Noord-Brabant |
| Netherlands | Ziekenhuisgroep Twente ( Site 0469) | Hengelo | Overijssel |
| Netherlands | Ziekenhuis Hilversum ( Site 0466) | Hilversum | Noord-Holland |
| Netherlands | Medisch Centrum Leeuwarden ( Site 0477) | Leeuwarden | Fryslan |
| Netherlands | Radboud University Medical Center ( Site 0470) | Nijmegen | Gelderland |
| Netherlands | VieCuri Medisch Centrum ( Site 0487) | Venlo | Limburg |
| Russian Federation | Chelyabinsk Regional Clinical Oncological Dispensary ( Site 0565) | Chelyabinsk | Chelyabinskaya Oblast |
| Russian Federation | Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0585) | Krasnoyarsk | Krasnoyarskiy Kray |
| Russian Federation | Central Clinical Hospital with Polyclinic ( Site 0562) | Moscow | Moskva |
| Russian Federation | National Medical Research Radiological Center ( Site 0556) | Moscow | Moskva |
| Russian Federation | Russian Scientific Center of Radiology ( Site 0559) | Moscow | Moskva |
| Russian Federation | SBIH City clinical hospital named after D.D. Pletniov ( Site 0575) | Moscow | Moskva |
| Russian Federation | Volga District Medical Center Federal Medical and Biological Agency ( Site 0572) | Nizhny Novgorod | Nizhegorodskaya Oblast |
| Russian Federation | Omsk Clinical Oncology Dispensary ( Site 0568) | Omsk | Omskaya Oblast |
| Russian Federation | Clinical Research Center of specialized types medical care-Oncology ( Site 0570) | Saint Petersburg | Sankt-Peterburg |
| Russian Federation | Russian Scientific Center of Radiology and Surgical Technologies ( Site 0567) | Saint Petersburg | Sankt-Peterburg |
| Russian Federation | SPb SBHI City Clinical Oncological Dispensary ( Site 0571) | Saint Petersburg | Sankt-Peterburg |
| Russian Federation | Leningrad Regional Oncology Center ( Site 0588) | Saint-Petersburg | Sankt-Peterburg |
| Russian Federation | SBHI Samara Regional Clinical Oncology Dispensary ( Site 0576) | Samara | Samarskaya Oblast |
| Russian Federation | Tomsk National Research Medical Center of Russian Academy of Sciences ( Site 0579) | Tomsk | Tomskaya Oblast |
| Spain | Hospital Clinic ( Site 0323) | Barcelona | |
| Spain | Hospital del Mar ( Site 0333) | Barcelona | |
| Spain | Hospital Josep Trueta ( Site 0321) | Girona | Gerona |
| Spain | Instituto Catalan de Oncologia - ICO ( Site 0330) | L Hospitalet De Llobregat | Barcelona |
| Spain | Hospital Clinico San Carlos ( Site 0324) | Madrid | |
| Spain | Hospital Universitario HM Sanchinarro ( Site 0322) | Madrid | |
| Spain | Hospital Universitario Ramon y Cajal ( Site 0328) | Madrid | |
| Spain | Hospital Universitario Virgen de la Victoria ( Site 0337) | Malaga | |
| Spain | Hospital Consorci Sanitari Parc Tauli ( Site 0335) | Sabadell | Barcelona |
| Spain | Hospital Universitario Marques de Valdecilla ( Site 0336) | Santander | Cantabria |
| Spain | Hospital Virgen del Rocio ( Site 0329) | Sevilla | |
| Taiwan | China Medical University Hospital ( Site 0132) | Taichung | |
| Taiwan | Taichung Veterans General Hospital ( Site 0133) | Taichung | |
| Taiwan | National Cheng Kung University Hospital ( Site 0134) | Tainen | Tainan |
| Taiwan | National Taiwan University Hospital ( Site 0131) | Taipei | |
| Taiwan | Taipei Veterans General Hospital ( Site 0135) | Taipei | |
| United Kingdom | University Hospitals Bristol NHS Foundation Trust ( Site 0530) | Bristol | Bristol, City Of |
| United Kingdom | Cambridge University Hospitals NHS Trust ( Site 0540) | Cambridge | Cambridgeshire |
| United Kingdom | Barts Cancer Institute ( Site 0483) | London | London, City Of |
| United Kingdom | Mount Vernon Cancer Centre ( Site 0536) | Northwood | Hertfordshire |
| United Kingdom | Weston Park Hospital ( Site 0539) | Sheffield | England |
| United Kingdom | University of North Midlands NHS Foundation Trust ( Site 0527) | Stoke-on-Trent | Staffordshire |
| United Kingdom | Royal Marsden Hospital ( Site 0526) | Sutton | England |
| United Kingdom | Torbay Hospital ( Site 0532) | Torquay | Devon |
| United States | Georgia Cancer Center at Augusta University ( Site 0026) | Augusta | Georgia |
| United States | University of Colorado Cancer Center ( Site 0022) | Aurora | Colorado |
| United States | St. Vincent Frontier Cancer Center ( Site 0016) | Billings | Montana |
| United States | Mount Sinai Hospital Medical Center ( Site 0042) | Chicago | Illinois |
| United States | University Hospitals Cleveland Medical Center ( Site 0036) | Cleveland | Ohio |
| United States | Henry Ford Health System ( Site 0039) | Detroit | Michigan |
| United States | Karmanos Cancer Institute ( Site 0077) | Detroit | Michigan |
| United States | Duke Cancer Center ( Site 0010) | Durham | North Carolina |
| United States | Inova Schar Cancer Institute ( Site 0006) | Fairfax | Virginia |
| United States | St. Joseph Heritage Healthcare ( Site 0069) | Fullerton | California |
| United States | Cancer & Hematology Centers of Western Michigan ( Site 0013) | Grand Rapids | Michigan |
| United States | John Theurer Cancer Center at Hackensack University Medical Center ( Site 0004) | Hackensack | New Jersey |
| United States | Comprehensive Cancer Centers of Nevada ( Site 0092) | Las Vegas | Nevada |
| United States | University of Southern California Norris Comprehensive Cancer Center ( Site 0061) | Los Angeles | California |
| United States | Methodist Hospital- Merriillville ( Site 0008) | Merrillville | Indiana |
| United States | University of South Alabama, Mitchell Cancer Institute ( Site 0065) | Mobile | Alabama |
| United States | Carolina Urologic Research Center ( Site 0070) | Myrtle Beach | South Carolina |
| United States | Yale Cancer Center ( Site 0038) | New Haven | Connecticut |
| United States | USC Norris Oncology Hematology Newport Beach ( Site 0093) | Newport Beach | California |
| United States | Nebraska Cancer Specialists ( Site 0034) | Omaha | Nebraska |
| United States | Oregon Health Sciences University ( Site 0031) | Portland | Oregon |
| United States | Virginia Cancer Institute ( Site 0052) | Richmond | Virginia |
| United States | Blue Ridge Cancer Care ( Site 0086) | Roanoke | Virginia |
| United States | Washington University School of Medicine ( Site 0057) | Saint Louis | Missouri |
| United States | W. G. Bill Hefner VA Medical Center ( Site 0029) | Salisbury | North Carolina |
| United States | University of California San Francisco ( Site 0023) | San Francisco | California |
| United States | Associated Medical Professionals of NY ( Site 0060) | Syracuse | New York |
| United States | Moffitt Cancer Center ( Site 0080) | Tampa | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Merck Sharp & Dohme LLC |
United States, Argentina, Australia, Austria, Brazil, Canada, Chile, China, Colombia, France, Germany, Ireland, Israel, Italy, Japan, Korea, Republic of, Netherlands, Russian Federation, Spain, Taiwan, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overall Survival (OS) | OS was defined as the time from randomization to death due to any cause. The OS was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants without documented death at the time of the analysis were censored at the date of the last follow-up. | Up to 36.5 months | |
| Primary | Radiographic Progression-free Survival (rPFS) Per Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) | rPFS was defined as the time from randomization to occurrence of: radiological tumor progression using RECIST 1.1 as assessed by BICR; progression of bone lesions using PCWG criteria; or death due to any cause. Progression as per RECIST 1.1 was =20% increase in sum of diameters of target lesions and progression of existing non-target lesions. Progression of bone lesions by PCWG criteria was the appearance of =2 new bone lesions on bone scan, that have been confirmed to not represent tumor flare, and was persistent for =6 weeks. The rPFS was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants without a rPFS event were censored at the date of last disease assessment. | Up to approximately 28 months | |
| Secondary | Time to Initiation of the First Subsequent Anti-cancer Therapy (TFST) | TFST was defined as the time from randomization to initiation of the first subsequent anti-cancer therapy or death; whichever occurred first. The TFST was calculated using the product-limit (Kaplan-Meier) method for censored data. Any participant not known to have further subsequent therapy or death was censored at the last known time that no subsequent new anti-cancer therapy was received. | Up to approximately 28 months | |
| Secondary | Prostate-specific Antigen (PSA) Response Rate | The Prostate-specific Antigen (PSA) response rate was the percentage of participants who had PSA response defined as a reduction in the PSA level from baseline by =50%. The reduction in PSA level was confirmed by an additional PSA evaluation performed =3 weeks from the original response. The analysis was performed on participants who had baseline PSA measurements. | Up to 36.5 months | |
| Secondary | Objective Response Rate (ORR) Per Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review | ORR was defined as the percentage of participants with complete response (CR: disappearance of all target lesions per RECIST 1.1; and no evidence of disease (NED) on bone scan per PCWG) or partial response (PR: at least a 30% decrease in the sum of diameters of target lesions per RECIST 1.1; and non-progressive disease, non-evaluable [NE], or NED on bone scan or CR with non-progressive disease or NE bone scan per PCWG). | Up to 36.5 months | |
| Secondary | Duration of Response (DOR) Per Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review | DOR was defined as the time from first documented evidence of complete response (CR) or partial response (PR) per PCWG and RECIST 1.1 criteria until progressive disease (PD) or death. PD per RECIST 1.1 was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. PD per PCWG was the appearance of =2 new bone lesions on bone scan, that have been confirmed to not represent tumor flare, and were persistent for =6 weeks. The DOR was calculated using the product-limit (Kaplan-Meier) method for censored data. If a participant had not progressed, the participant was censored at the date of last disease assessment. | Up to 36.5 months | |
| Secondary | Time to Pain Progression (TTPP) as Assessed by Brief Pain Inventory-Short Form (BPI-SF) Item 3 ("Worst Pain in 24 Hours") and Opiate Analgesic Use Assessed by the Analgesic Quantification Algorithm [AQA] Score | TTPP was defined as the time from randomization to pain progression as determined by Item 3 of the BPI-SF and by the AQA score. Pain progression was defined as: For participants asymptomatic at baseline: a =2-point change from baseline in the average (4-7 days) BPI-SF item 3 score at 2 consecutive visits OR initiation of opioid use for pain For participants symptomatic at baseline (average BPI-SF Item 3 score >0 and/or currently taking opioids:, a =2-point change from baseline in the average BPI-SF Item 3 score and an average worst pain score =4 and no decrease in average opioid use (=1-point decrease in AQA score from a starting value of 2 or higher) OR any increase in opioid use at 2 consecutive follow-up visits. TTPP was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants who had > 2 consecutive visits that were not evaluable for pain progression were censored at the last evaluable assessment. |
Up to 36.5 months | |
| Secondary | Time to First Symptomatic Skeletal-related Event (SSRE) | SSRE was the time from randomization to the first symptomatic skeletal-related event defined as: Use of external-beam radiation therapy (EBRT) to prevent or relieve skeletal symptoms Occurrence of new symptomatic pathologic bone fracture (vertebral or non-vertebral) Occurrence of spinal cord compression Tumor-related orthopedic surgical intervention, whichever occurs first. The SSRE was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants without symptomatic skeletal-related events were censored at the last evaluable assessment. |
Up to 36.5 months | |
| Secondary | Time to Prostate-specific Antigen (PSA) Progression | The time to PSA progression was the time from randomization to PSA progression. The PSA progression date was defined as the date of: =25% increase and =2 ng/mL above the nadir, confirmed by a second value =3 weeks later if there was PSA decline from baseline; OR =25% increase and =2 ng/mL increase from baseline beyond 12 weeks if there was no PSA decline from baseline Time to PSA progression was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants without PSA progression were censored at the last evaluable assessment. |
Up to 36.5 months | |
| Secondary | Time to Radiographic Soft Tissue Progression Per Soft Tissue Rules of Prostate Cancer Working Group (PCWG)-Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) | The time to radiographic soft tissue progression was defined as the time from randomization to radiographic soft tissue progression per soft tissue rules of PCWG-modified RECIST 1.1 as assessed by BICR. Progression was defined as =20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of =5 mm. The appearance of one or more new lesions was also considered progression. Time to radiographic soft tissue progression was calculated using the product-limit (Kaplan-Meier) method for censored data. Participants without radiographic soft tissue progression were censored at the last evaluable assessment. | Up to 36.5 months | |
| Secondary | Number of Participants Who Experienced an Adverse Event (AE) | An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experienced an AE is presented. | Up to approximately 30 months | |
| Secondary | Number of Participants Who Discontinued Study Treatment Due To an Adverse Event (AE) | An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued study treatment due to an AE is presented. | Up to approximately 27 months |
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