Prostatic Neoplasms Clinical Trial
— KEYLYNK-010Official title:
A Phase 3, Randomized Open-label Study of Pembrolizumab (MK-3475) Plus Olaparib Versus Abiraterone Acetate or Enzalutamide in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) Who Are Unselected for Homologous Recombination Repair Defects and Have Failed Prior Treatment With One Next-generation Hormonal Agent (NHA) and Chemotherapy (KEYLYNK-010)
| Verified date | January 2024 |
| 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 the polyadenosine 5'-diphosphoribose poly (ADP-ribose) polymerase (PARP) inhibitor olaparib and pembrolizumab in the treatment of participants with mCRPC who have failed to respond to either abiraterone acetate or enzalutamide (but not both) and to chemotherapy. The primary study hypotheses are that the combination of pembrolizumab plus olaparib is superior to abiraterone acetate or enzalutamide with respect to: 1. Overall Survival (OS) and 2. Radiographic progression-free survival (rPFS) per Prostate Cancer Working Group (PCWG)-modified Response Evaluation Criteria in Solid Tumors Version 1.1 as assessed by blinded independent central review (BICR) As of Amendment 06, the Data Monitoring Committee (DMC) is no longer applicable. Participants still on treatment may have the option to continue receiving study intervention or SOC if they are deriving clinical benefit, until criteria for discontinuation are met. Participants who are still on study treatment and deriving clinical benefit will no longer have tumor response assessments by BICR. However, local tumor imaging assessments should continue per SOC schedule. In addition, ePRO assessments will no longer be performed and biomarker samples will no longer be collected.
| Status | Completed |
| Enrollment | 793 |
| Est. completion date | January 27, 2024 |
| Est. primary completion date | March 14, 2022 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology - Has prostate cancer progression while receiving androgen deprivation therapy (or post bilateral orchiectomy) within 6 months before screening - Has current evidence of metastatic disease documented by bone lesions on bone scan and/or soft tissue disease shown by computed tomography/magnetic resonance imaging (CT/MRI) - Has received prior treatment with abiraterone acetate OR enzalutamide, but not both - Have disease that progressed during or after treatment with abiraterone acetate for either metastatic hormone-sensitive prostate cancer (mHSPC) or mCRP or enzalutamide for mCRPC for at least 8 weeks (at least 14 weeks for participants with bone progression) - Participants that received abiraterone acetate for mHSPC may not have received abiraterone acetate or enzalutamide for mCRPC - Have received docetaxel chemotherapy regimen for mCRPC and have had progressive disease during or after treatment with docetaxel - Has ongoing androgen deprivation with serum testosterone <50 ng/dL (<2.0 nM) - If receiving bone resorptive therapy, including but not limited to bisphosphonates or denosumab, must have been receiving stable doses before randomization - Must agree to refrain from donating sperm during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention PLUS be abstinent from heterosexual intercourse OR must agree to use contraception unless confirmed to be azoospermic - Contraception use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions is more stringent than the requirement above, the local label requirements are to be followed. - Has provided tumor tissue from a fresh core or excisional biopsy (obtained within 12 months of screening) from soft tissue not previously irradiated. Samples from tumors progressing at 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 the past 2 years - Has a history of (noninfectious) pneumonitis requiring steroids, or has current pneumonitis - Has known active human immunodeficiency virus (HIV), hepatitis B virus (e.g., hepatitis B surface antigen reactive) or hepatitis C virus (HCV) infection (e.g., HCV RNA [qualitative] is detected) - Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis - Has a history of seizure or any condition that may predispose to seizure - Has a history of loss of consciousness within 12 months of screening - Has myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or has features suggestive of MDS/AML - Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy - Has (=Grade 3) hypersensitivity to pembrolizumab and/or any of its excipients - Has known hypersensitivity to the components or excipients in olaparib, abiraterone acetate, prednisone or prednisolone, or enzalutamide - Has symptomatic congestive heart failure (New York Heart Association Class III or IV heart disease) - Has received an anticancer monoclonal antibody (mAb) before randomization - Has received prior treatment with olaparib or any other PARP inhibitor - Has received prior treatment with apalutamide or darolutamide - Has received prior treatment with enzalutamide or apalutamide for metastatic hormone-sensitive prostate cancer - Has used herbal products that may have hormonal anti-prostate cancer activity and/or are known to decrease PSA (e.g., saw palmetto) before the date of randomization - Has received prior treatment with radium or other therapeutic radiopharmaceuticals for prostate cancer - Has received prior treatment with an anti-PD-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., CTLA-4, OX-40, or CD137) - Is currently receiving either strong or moderate inhibitors of cytochrome P450 [CYP] (CYP3A4) that cannot be discontinued for the duration of the study - Has received a previous allogenic bone marrow transplant or double umbilical cord transplantation (dUCBT) or a solid organ transplant - Has received a live vaccine within 30 days prior to the date of randomization - Is currently participating in or has participated in a study of an investigational agent, or has used an investigational device, within 4 weeks before the date of randomization - Has a bone "superscan" - Is expecting to father children within the projected duration of the study, starting with the screening visit through 90 days after the last dose of study intervention |
| 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 ( Site 1011) | Buenos Aires | |
| Argentina | Instituto Medico Alexander Fleming ( Site 1010) | Buenos Aires | |
| Argentina | CEMAIC ( Site 1014) | Cordoba | |
| Argentina | Sanatorio Parque ( Site 1002) | Rosario | Santa Fe |
| Australia | Box Hill Hospital ( Site 0146) | Box Hill | Victoria |
| Australia | St. Vincent's Hospital ( Site 0158) | Darlinghurst | New South Wales |
| Australia | Royal Brisbane and Women s Hospital ( Site 0155) | Herston | Queensland |
| Australia | Macquarie University ( Site 0151) | Macquarie University | New South Wales |
| Australia | Peter MacCallum Cancer Centre ( Site 0152) | Melbourne | Victoria |
| Australia | Fiona Stanley Hospital ( Site 0162) | Murdoch | Western Australia |
| Australia | Port Macquarie Base Hospital ( Site 0153) | Port Macquarie | New South Wales |
| Australia | John Flynn Hospital & Medical Centre ( Site 0164) | Tugun | Queensland |
| Australia | Calvary Mater Newcastle ( Site 0148) | Waratah | New South Wales |
| Australia | Southern Medical Day Care Centre ( Site 0160) | Wollongong | 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 | |
| Brazil | IBCC - Instituto Brasileiro de Controle do Câncer ( Site 1040) | São Paulo | Sao Paulo |
| Canada | William Osler Health System (Brampton Civic Hospital) ( Site 0121) | Brampton | Ontario |
| Canada | Cross Cancer Institute ( Site 0110) | Edmonton | Alberta |
| Canada | Nova Scotia Health Authority QEII-HSC ( Site 0114) | Halifax | Nova Scotia |
| Canada | Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0116) | Hamilton | Ontario |
| Canada | BC Cancer-Kelowna - Sindi Ahluwalia Hawkins Centre ( Site 0113) | Kelowna | British Columbia |
| Canada | CHUQ-Univ 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 | BC Cancer-Vancouver Center ( Site 0112) | Vancouver | British Columbia |
| 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 |
| 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 | Bretagne |
| France | Centre Jean Perrin ( Site 0434) | Clermont-Ferrand | Auvergne |
| France | Centre Leon Berard ( Site 0422) | Lyon | Rhone |
| France | Institut Paoli Calmettes ( Site 0419) | Marseille | Bouches-du-Rhone |
| France | Institut Regional du Cancer de Montpellier - ICM ( Site 0443) | Montpellier | Herault |
| 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 | Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0301) | Berlin | |
| Germany | Universitaetsklinikum Duesseldorf ( Site 0306) | Duesseldorf | Nordrhein-Westfalen |
| Germany | Universitaetsklinikum Erlangen ( Site 0303) | Erlangen | Bayern |
| Germany | Universitaetsklinikum Freiburg - Medizinische Klinik ( Site 0304) | Freiburg | Baden-Wurttemberg |
| 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 | Krankenhaus der Barmherzigen Brueder Trier ( Site 0310) | Trier | Rheinland-Pfalz |
| Germany | Universitaetsklinik fuer Urologie ( Site 0307) | Tuebingen | Baden-Wurttemberg |
| Ireland | Tallaght University Hospital ( Site 0730) | Dublin | |
| Ireland | Mid Western Cancer Centre ( Site 0728) | Limerick | |
| Israel | Ha Emek Medical Center ( Site 0548) | Afula | |
| Israel | Assaf Harofe ( Site 0547) | Be'er- Ya'akov | |
| Israel | Soroka Medical Center ( Site 0549) | Beer Sheva | |
| 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 | Medical Oncology Ospedale San Donato ( Site 0461) | Arezzo | |
| Italy | Policlinico S.Orsola-Malpighi ( Site 0453) | Bologna | |
| Italy | Azienda Ospedaliera Cannizzaro ( Site 0458) | Catania | |
| Italy | Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori ( Site 0462) | Meldola | Emilia-Romagna |
| Italy | Azienda Ospedaliera San Camillo Forlanini ( Site 0455) | Roma | |
| Italy | Fondazione Policlinico Universitario A. Gemelli ( Site 0463) | Roma | |
| Italy | Istituto Clinico Humanitas Research Hospital ( Site 0452) | Rozzano | Lombardia |
| 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 | Fuji City General Hospital ( Site 0725) | Fuji | Shizuoka |
| 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 | Kobe City Medical Center General Hospital ( Site 0726) | Kobe | Hyogo |
| 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 | Nagano Municipal Hospital ( Site 0723) | Nagano | |
| Japan | Nagasaki University Hospital ( Site 0719) | Nagasaki | |
| Japan | Osaka International Cancer Institute ( Site 0722) | Osaka | |
| 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 | Fujita Health University Hospital ( Site 0724) | Toyoake | Aichi |
| 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 0176) | Goyang-si | Kyonggi-do |
| Korea, Republic of | Chonnam National University Hwasun Hospital ( Site 0174) | Hwasun Gun | Jeonranamdo |
| Korea, Republic of | Samsung Medical Center ( Site 0172) | Seoul | |
| Korea, Republic of | Severance Hospital Yonsei University Health System ( Site 0173) | Seoul | |
| Korea, Republic of | Asan Medical Center ( Site 0171) | Songpagu | Seoul |
| Netherlands | Antoni van Leeuwenhoek Ziekenhuis ( Site 0480) | Amsterdam | Noord-Holland |
| Netherlands | Vrije Universiteit Medisch Centrum ( Site 0479) | Amsterdam | Noord-Holland |
| Netherlands | Ziekenhuisgroep Twente ( Site 0469) | Hengelo | Overijssel |
| Netherlands | Spaarne Ziekenhuis ( Site 0473) | Hoofddorp | Noord-Holland |
| Netherlands | Medisch Centrum Leeuwarden ( Site 0477) | Leeuwarden | Fryslan |
| Netherlands | Haaglanden MC - locatie Antoniushove ( Site 0471) | Leidschendam | Zuid-Holland |
| Netherlands | Radboud University Medical Center ( Site 0470) | Nijmegen | Gelderland |
| Netherlands | Erasmus MC ( Site 0475) | Rotterdam | Zuid-Holland |
| Netherlands | Franciscus Gasthuis en Vlietland ( Site 0489) | Schiedam | Zuid-Holland |
| New Zealand | Auckland City Hospital ( Site 0193) | Auckland | |
| 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 | Russian Scientific Center of Roentgenoradiology ( Site 0559) | Moscow | Moskva |
| 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 | SBHI Leningrad Regional Oncology Dispensary ( Site 0588) | Saint Petersburg | Sankt-Peterburg |
| Russian Federation | SBHI Samara Regional Clinical Oncology Dispensary ( Site 0576) | Samara | Samarskaya Oblast |
| Russian Federation | Tomsk National Scientific Medical Center of Russian Academy of Science ( Site 0579) | Tomsk | Tomskaya Oblast |
| Spain | Hospital Clinic ( Site 0323) | Barcelona | |
| Spain | Hospital del Mar ( Site 0333) | Barcelona | |
| Spain | Hospital General Universitari Vall d Hebron ( Site 0334) | Barcelona | |
| Spain | Hospital San Pedro de Alcantara ( Site 0326) | Caceres | Extremadura |
| Spain | Hospital Josep Trueta ( Site 0321) | Girona | Gerona |
| Spain | Instituto Catalan de Oncologia - ICO ( Site 0330) | L Hospitalet De Llobregat | Barcelona |
| Spain | Hospital Universitario Virgen de la Victoria ( Site 0337) | Malaga | |
| Spain | Hospital Quiron Madrid ( Site 0325) | Pozuelo de Alarcon | Madrid |
| Spain | Hospital Parc Tauli ( Site 0335) | Sabadell | Barcelona |
| 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 | Mount Vernon Cancer Centre ( Site 0536) | Northwood | |
| 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 | Musgrove Park Hospital ( Site 0537) | Taunton | England |
| United Kingdom | Torbay Hospital ( Site 0532) | Torquay | Devon |
| United States | University of New Mexico Cancer Center ( Site 0048) | Albuquerque | New Mexico |
| United States | Georgia Cancer Center at Augusta University ( Site 0026) | Augusta | Georgia |
| United States | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 0005) | Baltimore | Maryland |
| United States | St. Vincent Frontier Cancer Center ( Site 0016) | Billings | Montana |
| United States | Beth Israel Deaconess Medical Ctr. ( Site 0093) | Boston | Massachusetts |
| United States | Dana Farber Cancer Institute ( Site 0033) | Boston | Massachusetts |
| United States | Gabrail Cancer Center-Research ( Site 0097) | Canton | Ohio |
| United States | Duke Cancer Center Cary ( Site 0010) | Cary | North Carolina |
| United States | The Urology Group- Cincinnati ( Site 0094) | Cincinnati | Ohio |
| United States | University Hospitals of Cleveland Seidman Cancer Center ( Site 0036) | Cleveland | Ohio |
| United States | Barbara Ann Karmanos Cancer Institute ( Site 0077) | Detroit | Michigan |
| United States | Henry Ford Health System ( Site 0039) | Detroit | Michigan |
| United States | St. Joseph Heritage Healthcare ( Site 0069) | Fullerton | California |
| United States | Memorial Medical Center ( Site 0095) | Las Cruces | New Mexico |
| United States | Comprehensive Cancer Centers of Nevada ( Site 0092) | Las Vegas | Nevada |
| United States | UCLA Hematology/Oncology - Santa Monica ( Site 0081) | Los Angeles | California |
| United States | Froedtert and Medical College of Wisconsin ( Site 0045) | Milwaukee | Wisconsin |
| United States | Carolina Urologic Research Center ( Site 0070) | Myrtle Beach | South Carolina |
| United States | Tulane Cancer Center ( Site 0066) | New Orleans | Louisiana |
| United States | Nebraska Cancer Specialists ( Site 0034) | Omaha | Nebraska |
| United States | Quincy Medical Group ( Site 0021) | Quincy | Illinois |
| United States | Virginia Cancer Institute ( Site 0052) | Richmond | Virginia |
| United States | Blue Ridge Cancer Care ( Site 0086) | Roanoke | Virginia |
| United States | Huntsman Cancer Institute ( Site 0002) | Salt Lake City | Utah |
| United States | Seattle Cancer Care Alliance ( Site 0079) | Seattle | Washington |
| United States | Associated Medical Professionals of NY ( Site 0060) | Syracuse | New York |
| United States | Chesapeake Urology Research Associates ( Site 0076) | Towson | Maryland |
| United States | Sibley Memorial Hospital ( Site 0096) | Washington | District of Columbia |
| United States | UMass Memorial Medical Center ( Site 0053) | Worcester | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Merck Sharp & Dohme LLC |
United States, Argentina, Australia, Austria, Brazil, Canada, Chile, France, Germany, Ireland, Israel, Italy, Japan, Korea, Republic of, Netherlands, New Zealand, Russian Federation, Spain, Taiwan, United Kingdom,
Antonarakis ES, Park SH, Goh JC, Shin SJ, Lee JL, Mehra N, McDermott R, Sala-Gonzalez N, Fong PC, Greil R, Retz M, Sade JP, Yanez P, Huang YH, Begbie SD, Gafanov RA, De Santis M, Rosenbaum E, Kolinsky MP, Rey F, Chiu KY, Roubaud G, Kramer G, Sumitomo M, M — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overall Survival (OS) | Overall survival (OS) is defined as the time from randomization to death due to any cause. The nonparametric Kaplan-Meier method was used to estimate the survival curves. | Up to ~31 months | |
| Primary | Radiographic Progression-Free Survival (rPFS) | rPFS is defined as the time from randomization to the first documented progressive disease (PD) per PCWG-modified RECIST 1.1 based on BICR or death due to any cause, whichever occurred first. Per PCWG-modified RECIST 1.1, PD is 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 or =2 new bone lesions was also considered PD. PCWG-modified RECIST is similar to RECIST 1.1 with the exception that a confirmation assessment of PD (>4 weeks after the initial PD) is required for participants who remain on treatment following a documented PD per RECIST 1.1 and PCWG rules include new bone lesions. The rPFS per PCWG-modified RECIST as assessed by BICR for all participants is presented. The nonparametric Kaplan-Meier method was used to estimate the survival curves. | Up to ~31 months | |
| Secondary | Time to Initiation of the First Subsequent Anticancer Therapy (TFST) | TFST is the time from randomization to initiation of the first subsequent anticancer therapy defined as the first anti-cancer treatment not part of the study arm for a given participant, or death, whichever occurs first. The nonparametric Kaplan-Meier method was used to estimate the survival curves. | Up to ~31 months | |
| Secondary | Objective Response Rate (ORR) | ORR is 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) bone scan) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions per RECIST 1.1 and Non-PD, non-evaluable (NE), or NED bone scan or CR with non-PD or NE bone scan.) The percentage of participants who experienced CR or PR as assessed by BICR is presented. | Up to ~31 months | |
| Secondary | Duration of Response (DOR) | DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per PCWG-modified RECIST 1.1, PD is 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. The appearance of = 2 new bone lesions is also considered PD. DOR as assessed by BICR is presented. | Up to ~24 months | |
| Secondary | Time to Prostate-Specific Antigen (PSA) Progression | Time to PSA progression is defined as the time from randomization to PSA progression. PSA progression date is defined as the date of: 1) =25% increase and =2 ng/mL above the nadir, confirmed by a second value =3 weeks later if there is PSA decline from baseline, OR 2) =25% increase and =2 ng/mL increase from baseline beyond 12 weeks if there is no PSA decline from baseline. The nonparametric Kaplan-Meier method was used to estimate the survival curves. |
Up to ~31 months | |
| Secondary | Time to First Symptomatic Skeletal-Related Event (SSRE) | SSRE is defined as the time from randomization to the first symptomatic skeletal-related event, defined as whichever occurs first: First use of external-beam radiation therapy (EBRT) to prevent or relieve skeletal symptoms; Occurrence of new symptomatic pathologic bone fracture (vertebral or nonvertebral); Occurrence of spinal cord compression; or Tumor-related orthopedic surgical intervention |
Up to ~31 months | |
| Secondary | Time to Radiographic Soft Tissue Progression | Time to radiographic soft tissue progression is defined as the time from randomization to radiographic soft tissue progression per soft tissue rule of PCWG-modified RECIST 1.1. Progression is 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. The appearance of one or more new lesions is also considered progression. Time to radiographic soft tissue progression as assessed by BICR is presented. | Up to ~31 months | |
| Secondary | Time to Pain Progression (TTPP) | TTPP is defined as the time from randomization to pain progression as determined by Item 3 of the Brief Pain Inventory Short Form (BPI-SF) and by the Analgesic Quantification Algorithm (AQA) score. Pain progression is defined as: For participants who are 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 who are 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. Participants who had more than 2 consecutive visits that were not evaluable for pain progression were censored at the last evaluable assessment. |
Up to ~31 months | |
| Secondary | Number of Participants Who Experience an Adverse Event (AE) | An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experienced an adverse event are presented. | Up to ~31 months | |
| Secondary | Number of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE) | The number of participants who discontinue study treatment due to an AE are presented. | Up to ~880 Days |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04964271 -
Identification of Prostate Cancer Specific Markers in Patients Compared to Healthy Participants
|
||
| Completed |
NCT02546908 -
A Registry of Participants With Prostate Cancer in Asia
|
||
| Completed |
NCT04838626 -
Study of Diagnostic Performance of [18F]CTT1057 for PSMA-positive Tumors Detection
|
Phase 2/Phase 3 | |
| Recruiting |
NCT03101176 -
Multiparametric Ultrasound Imaging in Prostate Cancer
|
N/A | |
| Completed |
NCT01683994 -
Cabozantinib Plus Docetaxel and Prednisone for Advanced Prostate Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT04838613 -
Study of Diagnostic Performance of [18F]CTT1057 in BCR
|
Phase 3 | |
| Completed |
NCT02364531 -
A Canadian Observational Study in Metastatic Cancer of the Prostate: A Study of ZYTIGA Use in the Community Urology Setting
|
||
| Completed |
NCT01929655 -
Japanese BAY88-8223 Monotherapy Phase II Study
|
Phase 2 | |
| Active, not recruiting |
NCT05022849 -
A Study of JNJ-75229414 for Metastatic Castration-resistant Prostate Cancer Participants
|
Phase 1 | |
| Completed |
NCT03261999 -
Safety, Efficacy, and Pharmacokinetic Behavior of Leuprolide Mesylate (LMIS 25 mg) in Subjects With Prostate Cancer
|
Phase 3 | |
| Terminated |
NCT04907227 -
Study of Pembrolizumab (MK-3475) Plus Docetaxel Versus Placebo Plus Docetaxel in Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-3475-921/KEYNOTE-921)-China Extension
|
Phase 3 | |
| Active, not recruiting |
NCT03587285 -
A Pilot Study of Hormonal Therapy Combined With Central Memory T Cells (Tcm) for Patients With Advanced Prostate Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT02217566 -
Study of Abiraterone Acetate in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC), Chemo-Naive, Who Received a Prior Diethylstilbestrol Therapy
|
Phase 2 | |
| Not yet recruiting |
NCT04101305 -
Measurement of Circulating Tumor Cells in Prostate Cancer
|
||
| Recruiting |
NCT03066154 -
Oral Docetaxel (ModraDoc/r) in Combination With Hormonal Treatment and Radiation Therapy in High-risk Prostate Cancer
|
Phase 1 | |
| Active, not recruiting |
NCT02950064 -
A Study to Determine the Safety of BTP-114 for Treatment in Patients With Advanced Solid Tumors With BRCA Mutations
|
Phase 1 | |
| Withdrawn |
NCT02905201 -
A Prospective Compliance Registry for Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)
|
N/A | |
| Completed |
NCT02692976 -
Natural Dendritic Cells for Immunotherapy of Chemo-naive Metastatic Castration-resistant Prostate Cancer Patients
|
Phase 2 | |
| Terminated |
NCT01420965 -
Sipuleucel-T, CT-011, and Cyclophosphamide for Advanced Prostate Cancer
|
Phase 2 | |
| Completed |
NCT01441713 -
Treatment Frequency and Satisfaction in Patients With Advanced Prostate Cancer
|
N/A |