Phase III Study of DCVAC/PCa Added to Standard Chemotherapy for Men With Metastatic Castration Resistant Prostate Cancer

Metastatic Castration-resistant Prostate Cancer Clinical Trial

— VIABLE  

Official title:

A Randomized, Double Blind, Multicenter, Parallel-group, Phase III Study to Evaluate Efficacy and Safety of DCVAC/PCa Versus Placebo in Men With Metastatic Castration Resistant Prostate Cancer Eligible for 1st Line Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02111577
• Other study ID #: SP005
• Secondary ID: 2012-002814-38
• Status: Completed
• Phase: Phase 3
• Start date: May 26, 2014
• Est. completion date: January 28, 2020

Study information

• Verified date: March 2021
• Source: Sotio a.s.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The VIABLE study sought to confirm the hypothesis that the combination of docetaxel with DCVAC/PCa followed by a maintenance therapy with DCVAC/PCa would improve overall survival in patients with metastatic castration-resistant prostate cancer.

Description:

This was a randomized, double blind, placebo-controlled, multicenter, international, parallel-group phase III study. Patients with metastatic castration-resistant prostate cancer who were candidates to receive standard of care first-line chemotherapy with docetaxel plus prednisone were randomized 2:1 into one of two arms: an investigational arm (DCVAC/PCa) and a control arm (placebo) in addition to chemotherapy (docetaxel plus prednisone).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1182
• Est. completion date: January 28, 2020
• Est. primary completion date: January 28, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Male 18 years and older.
• Histologically or cytologically confirmed prostate adenocarcinoma.
• Presence of skeletal, or soft-tissue/visceral/nodal metastases according to one of the

following criteria:

• Confirmed pathological fracture related to the disease OR
• Confirmation of distant bone and/or soft-tissue and/or visceral metastases on CT or MRI scan or bone scintigraphy OR
• Positive pathology report of metastatic lesion
• Disease progression despite androgen-deprivation therapy (ADT) as indicated by:
• Prostate-specific antigen (PSA) increase that is = 2 ng/mL and = 25% above the minimum PSA as reached during ADT or above the pre-treatment level, if no response was observed and which is confirmed by a second value 1 or more weeks later OR
• Progression of measurable lymph nodes (short axis = 15 mm) or visceral lesion measurable per RECIST v1.1 criteria, confirmation by an independent review facility (IRF) required OR
• Two or more new lesions appearing on bone scan/imaging compared with a previous scan (confirmation by IRF required)
• Maintenance of castrate conditions: patients, who have not had a surgical orchiectomy, must continue with hormone therapy with gonadotropin releasing hormone/ luteinizing hormone-releasing hormone (GnRH/LHRH) agonists or antagonists to reach levels of serum testosterone of = 1.7 nmol/L (50 ng/dL). The duration of the castration period must be at least 4 months before screening as evidenced by combination of clinical/laboratory data (see section 6.8.1).
• Laboratory criteria:
• White blood cells (WBC) greater than 4,000/mm3 (4.0 x109/L)
• Neutrophil count greater than 1,500/mm3 (1.5 x109/L).
• Hemoglobin of at least 10 g/dL (100 g/L).
• Platelet count of at least 100,000/mm3 (100 x 109/L).
• Total bilirubin within normal limits (benign hereditary hyperbilirubinemias, e.g. Gilbert's syndrome, are permitted).
• Serum alanine aminotransferase, aspartate aminotransferase, and creatinine < 1.5x times the upper limit of normal (ULN).
• Life expectancy of at least 6 months based on Investigator's judgment.
• Eastern Cooperative Oncology Group (ECOG) Performance status 0-2.
• At least 4 weeks after surgery or radiotherapy before randomization.
• A minimum of 28 days beyond initiation of bisphosphonate or denosumab therapy before randomization.
• Recovery from primary local surgical treatment, radiotherapy or orchiectomy before randomization.
• Signed informed consent including patient's ability to comprehend its contents.

Exclusion criteria:

• Confirmed brain and/or leptomeningeal metastases (other visceral metastases are acceptable).
• Current symptomatic spinal cord compression requiring surgery or radiation therapy.
• Prior chemotherapy for prostate cancer.
• Patient co-morbidities:
• Subjects who are not indicated for chemotherapy treatment with first line Standard of Care chemotherapy (docetaxel and prednisone).
• HIV positive, human T-lymphotropic virus positive.
• Active hepatitis B (active hepatitis B), active hepatitis C (HCV), active syphilis.
• Evidence of active bacterial, viral or fungal infection requiring systemic treatment.
• Clinically significant cardiovascular disease including:
• symptomatic congestive heart failure.
• unstable angina pectoris.
• serious cardiac arrhythmia requiring medication.
• uncontrolled hypertension.
• myocardial infarction or ventricular arrhythmia or stroke within a 6 months before screening, known left ventricular ejection fraction (LVEF) < 40% or serious cardiac conduction system disorders, if a pacemaker is not present.
• Pleural and pericardial effusion of any NCI CTCAE grade.
• Peripheral neuropathy having a NCI CTCAE = grade 2.
• History of malignant disease (with the exception of non-melanoma skin tumors) in the preceding five years.
• Active autoimmune disease requiring treatment.
• History of severe forms of primary immune deficiencies.
• History of anaphylaxis or other serious reaction following vaccination.
• Known hypersensitivity to any constituent of the DCVAC/PCa or placebo product.
• Uncontrolled co-morbidities including, psychiatric or social conditions which, in the Investigator's opinion, would prevent participation in the trial.
• Systemic corticosteroids at doses greater than 40 mg hydrocortisone daily or equivalent for any reason other than treatment of PCa within 6 months before randomization.
• Ongoing systemic immunosuppressive therapy for any reason.
• Treatment with anti-androgens, inhibitors of adrenal-produced androgens or other hormonal tumor-focused treatment performed on the day of randomization (except for GnRH/LHRH agonists or antagonists) to exclude possible anti-androgen withdrawal response. This criterion is not applicable to subjects who have never responded to anti-androgen treatment, as there is no risk of anti-androgen withdrawal response.
• Treatment with immunotherapy against PCa within 6 months before randomization.
• Treatment with radiopharmaceutical within 8 weeks before randomization.
• Participation in a clinical trial using non-immunological experimental therapy within 4 weeks before randomization.
• Participation in a clinical trial using immunological experimental therapy (e.g., monoclonal antibodies, cytokines or active cellular immunotherapies) within 6 months before randomization.
• Refusal to sign the informed consent.

Related Conditions & MeSH terms

• Metastatic Castration-resistant Prostate Cancer
• Prostatic Neoplasms

Intervention

Biological:
• DCVAC/PCa
DCVAC/PCa concurrently with docetaxel plus prednisone every 3 weeks (± 7 days). DCVAC/PCa was administered at least 7 days before or and at least 7 days after the nearest chemotherapy (days 8-15 of chemotherapy cycles). After discontinuation of chemotherapy for any reason, each following dose of DCVAC/PCa was given every 4 weeks (-7/+14 days) for up to a total of 15 doses.
• Placebo
Placebo concurrently with docetaxel plus prednisone every 3 weeks (± 7 days). Placebo was administered at least 7 days before or and at least 7 days after the nearest chemotherapy (days 8-15 of chemotherapy cycles). After discontinuation of chemotherapy for any reason, each following dose of placebo was given every 4 weeks (-7/+14 days) for up to a total of 15 doses.

Locations

Country	Name	City	State
Austria	Universitatsklinikum fur Urologie und Andrologie	Salzburg
Austria	AKH Universitatskrankenhaus Wien	Wien
Austria	Krankenhaus Barmherzige Brueder	Wien
Belarus	N.N. Alexandrov National Research Center	Lesnoy
Belarus	Minsk City Oncological Hospital	Minsk
Belgium	Clinique d'Oncologie Medicale Institut Jules Bordet	Brussels
Belgium	Cliniques Universitaires Saint Luc- Urologie	Brussels
Belgium	Erasme Hospital- Urologie	Brussels
Belgium	Urologie UZ Gent	Gent
Belgium	Urology Department St. Elizabeth Ziekenhuis	Turnhout
Bulgaria	Specialized Hospital for Active treatment in Oncology	Haskovo
Bulgaria	Central Oncology Hospital	Plovdiv
Bulgaria	Complex Oncology Center	Plovdiv
Bulgaria	Multifunctional Hospital for Active Treatment Serdika	Sofia
Bulgaria	Specialized Hospital for Active Treatment of Oncology Diseases	Sofia
Croatia	General Hospital Varazdin	Varaždin
Croatia	Clinical Hospital Center Zagreb	Zagreb
Croatia	University Hospital Center Sisters of Charity	Zagreb
Czechia	Onkologicke centrum, Nemocnice Chomutov	Chomutov
Czechia	Klinika onkologie a radioterapie, Fakultni nemocnice	Hradec Kralove
Czechia	Nemocnice Jihlava, urologicke oddeleni	Jihlava
Czechia	Urologicke oddeleni, Krajska nemocnice	Liberec
Czechia	Onkologicka klinika, Fakultni nemocnice	Olomouc
Czechia	Klinika onkologicka, Fakultni nemocnice	Ostrava-Poruba
Czechia	Fakultni nemocnice Kralovske Vinohrady	Prague
Czechia	Fakultni nemocnice v Motole	Prague
Czechia	Thomayerova nemocnice	Prague
Czechia	Vseobecna fakultni nemocnice v Praze	Prague
Czechia	Krajska zdravotni, urologicke oddeleni	Usti nad Labem
Denmark	Rigshospitalet	Copenhagen
France	Hopital St. Joseph	Paris
France	Hospital Cochin, Service de Urologie	Paris
France	St-Louis IDF Medical Oncology	Paris
France	HEGP medical oncology	Paris Cedex 15
France	HIA Begin	Saint Mandé
France	Hospital Civil de Strasbourg	Strasbourg
Germany	Charite Universitatsklinikum Berlin	Berlin
Germany	Stadtisches Klinikum Braunschweig	Braunschweig
Germany	Universtatsklinikum Carl Gustav Carus	Dresden
Germany	Waldkrankenhaus St. Marien	Erlangen
Germany	Krankenhaus Nordwest	Frankfurt
Germany	Universitatsklinikum Halle (Saale)	Halle
Germany	Asklepios-Klinik Hamburg-Altona	Hamburg
Germany	Medizinische hochschule Hannover	Hannover
Germany	Vinzenkrankenhaus Hannover	Hannover
Germany	Universitatskinikum Jena	Jena
Germany	Klinik und Poliklinik Urologie	Köln
Germany	Universitatsmedizin Mannheim	Mannheim
Germany	Universtatsklinikum Munster	Münster
Germany	Studienpraxis Urologie	Nürtingen
Germany	Klinikum Oldenburg AOR	Oldenburg
Germany	Universitastsklinikum Tubingen	Tübingen
Germany	Universitatsklinikum Ulm	Ulm
Germany	Ammerland Klinik fur Urologie	Westerstede
Germany	Praxigemeinschaft fur Onkologie und Urologie	Wilhelmshaven
Hungary	Bajcsy-Zsilinsky Korhaz	Budapest
Hungary	Egyesitett Szent Istvan es Szent Laszlo Korhaz-Rendelointeszet	Budapest
Hungary	Magyar Honvedseg Egeszsegugyi Kozpont	Budapest
Hungary	Jasz-Nagykun-Szolnok Megyei	Szolnok
Italy	CRO Aviano	Aviano
Italy	A.O.U. Policlinico Vittorio Emanuele	Catania
Italy	A.O. Istituti Ospitalieri di Cremona	Cremona
Italy	A.O. Santa Croce e Carle Oespedale	Cuneo
Italy	Universita di Roma Sapienza	Rome
Italy	Azienda Ospedialiera Universitaria Senese	Sienna
Italy	Oncologia medica Ospedale S. Vincenzo	Taormina
Latvia	Paula Stradina Kliniska Universitates slimnica	Riga
Lithuania	Lithuanian University of Health Science Oncology Institute	Kaunas
Lithuania	Klaipeda University Hospital	Klaipeda
Lithuania	National Cancer Institute	Vilnius
Lithuania	Vilnius University Hospital	Vilnius
Netherlands	VU medical Center	Amsterdam
Netherlands	Wilhemina Ziekenhuis	Assen
Netherlands	Tergooi Ziekenhuizen	Hilversum
Netherlands	Spaarne Gasthuis	Hoofddorp
Netherlands	Oncology Medisch Centrum	Leeuwarden
Netherlands	UMC St.Radboud	Nijmegen
Netherlands	Oncology Maasstad Ziekenhuis	Rotterdam
Poland	Przychodnia Lekarska (KOMED)	Konin
Poland	Szpital im M.Kopernika	Lodz
Poland	Centrum Medyczne Ostrobramska	Warszawa
Poland	INSTYTUT im. Marii Sklodowskiej-Curie	Warszawa
Poland	Akademicki Szpital Kliniczny im. Jana Mikulicza-Radeckiego	Wroclaw
Portugal	Centro Hospitalar de Lisboa Norte, E.P.E - Hospital de Santa Maria	Lisboa
Portugal	Hospital da Luz	Lisboa
Portugal	Instituto Português de Oncologia do Porto Francisco Gentil, E.P.E	Porto
Serbia	CHC Zemun	Belgrade
Serbia	Clinical Center of Serbia	Belgrade
Serbia	Institute of Oncology and Radiology of Serbia	Belgrade
Serbia	KBC Bezanijska Kosa	Belgrade
Slovakia	J.Breza MEDICAL s.r.o.	Bratislava
Slovakia	Urologicka ambulancia CUIMED s.r.o.	Bratislava
Slovakia	Univerzitna nemocnica Martin	Martin
Slovakia	Urologicka ambulancia Uroexam, spol. s r.o.	Nitra
Slovakia	UROX s.r.o.	Piestany
Slovakia	Urocentrum MILAB s.r.o.	Presov
Slovakia	Privatna urologicka ambulancia	Trencin
Slovakia	Fakultna nemocnica s poliklinikou Zilina	Zilina
Spain	Hospital Universitario Príncipe de Asturias	Alcalá de Henares
Spain	Hospital Clinic I Provincial de Barcelona	Barcelona
Spain	Centro Integral Oncológico Clara Campal (CIOCC)	Madrid
Spain	Hosp. Clinico Univ. San Carlos	Madrid
Spain	Hospital General Universitario Gregorio Maranón	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario Puerta de Hierro de Majadahonda	Madrid
Spain	Instituto de Investigaciones Sanitarias (IIS), Fundacíon Jimenez Díaz (FJD)	Madrid
Spain	Hospital Carlos Haya	Malaga
Spain	Hospital Universitario Quiron Madrid	Pozuelo de Alarcón
Sweden	Örebro University Hospital	Örebrö
Sweden	University Hospital Umeå, Dept Oncology	Umeå
United Kingdom	The Clatterbridge Cancer Centre	Bebington
United Kingdom	University Hospitals Birmingham NHS Foundation Trust	Birmingham
United Kingdom	Bristol Haematology and Oncology Centre	Bristol
United Kingdom	Cambridge University Hospitals NHS Foundation Trust	Cambridge
United Kingdom	St. Luke's Cancer Centre Royal Surrey County Hospital NHS Foundation Trust	Guildford
United Kingdom	Royal Free Hospital	London
United Kingdom	The Royal Marsden NHS Foundation Trust	London
United Kingdom	The Christie NHS Foundation Trust	Manchester
United Kingdom	Northern Centre for Cancer Care, Freeman Hospital	Newcastle upon Tyne
United States	Arlington Cancer Center	Arlington	Texas
United States	Winship Cancer Institute of Emory University	Atlanta	Georgia
United States	Rocky Mountain Cancer Centers	Aurora	Colorado
United States	University of Colorado	Aurora	Colorado
United States	Urologic Consultants of Southeastern Pennsylvania	Bala-Cynwyd	Pennsylvania
United States	University of Maryland Greenebaum Cancer Center	Baltimore	Maryland
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	New Jersey Hematology Oncology Associates	Brick	New Jersey
United States	Montefiore Medical Center	Bronx	New York
United States	Ironwood Cancer & Research Centers	Chandler	Arizona
United States	Associates in Oncology & Hematology	Chattanooga	Tennessee
United States	UC Health University of Cincinnati	Cincinnati	Ohio
United States	Compassionate Care Research Group, Inc.	Corona	California
United States	Henry Ford Health System	Detroit	Michigan
United States	Karmanos Cancer Center	Detroit	Michigan
United States	Cancer Care Associates St. Luke's University and Health Network	Easton	Pennsylvania
United States	California Cancer Associates for Research and Excellence	Encinitas	California
United States	Fort Belvoir Community Hospital	Fort Belvoir	Virginia
United States	Compassionate Care Research Group, Inc.	Fountain Valley	California
United States	St. Joseph Heritage Healthcare	Fullerton	California
United States	Comprehensive Cancer Research Centers of Nevada	Henderson	Nevada
United States	UT Health, Internal Medicine, Division of Oncology	Houston	Texas
United States	Saint Luke's Cancer Institute	Kansas City	Kansas
United States	Premier Urology Associates, LLC / AdvanceMed Research	Lawrenceville	New Jersey
United States	Hao Wei Zhang, MD, LLC	Los Angeles	California
United States	Univ. of Miami, Sylvester Comprehensive Cancer Center	Miami	Florida
United States	Minnesota Oncology Hematology, P.A.	Minneapolis	Minnesota
United States	University of South Alabama Mitchell Cancer Institute	Mobile	Alabama
United States	West Virginia University Mary Babb Randolph Cancer Center	Morgantown	West Virginia
United States	Carolina Urologic Research Center	Myrtle Beach	South Carolina
United States	Cancer Institute of New Jersey	New Brunswick	New Jersey
United States	Yale Cancer Center	New Haven	Connecticut
United States	Tulane University	New Orleans	Louisiana
United States	Mount Sinai Medical Center	New York	New York
United States	Virginia Oncology Associates	Norfolk	Virginia
United States	Eastern CT Hematology and Oncololgy Associates	Norwich	Connecticut
United States	GU Research Network	Omaha	Nebraska
United States	Nebraska Cancer Specialists	Omaha	Nebraska
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	UPMC Cancer Center	Pittsburgh	Pennsylvania
United States	Texas Health Physicians Group	Plano	Texas
United States	Oregon Health & Science University	Portland	Oregon
United States	Desert Hematology Oncology Medical Group	Rancho Mirage	California
United States	Compassionate Care Research Group, Inc.	Riverside	California
United States	Associates In Oncology/Hematology,P.C	Rockville	Maryland
United States	Utah Cancer Specialists	Salt Lake City	Utah
United States	Cancer Care Network of South Texas	San Antonio	Texas
United States	Sharp Clinical Oncology Research	San Diego	California
United States	Mayo Clinic	Scottsdale	Arizona
United States	Virginia Mason Medical Center	Seattle	Washington
United States	SUNY Upstate Medical University	Syracuse	New York
United States	Northwest Medical Specialties, PLLC	Tacoma	Washington
United States	Northwest Cancer Specialists, P.C.	Tualatin	Oregon
United States	Tyler Hematology Oncology	Tyler	Texas
United States	Medstar Georgetown University Hospital	Washington	District of Columbia
United States	University of Kansas Cancer Center & Medical Pavilion	Westwood	Kansas
United States	Oncology Institute of Hope and Innovation	Whittier	California
United States	Umass Memorial Medical Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Sotio a.s.

Countries where clinical trial is conducted

United States,  Austria,  Belarus,  Belgium,  Bulgaria,  Croatia,  Czechia,  Denmark,  France,  Germany,  Hungary,  Italy,  Latvia,  Lithuania,  Netherlands,  Poland,  Portugal,  Serbia,  Slovakia,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival, Intention-to-treat Population	Overall survival is defined as the time from randomization until death due to any cause.	From randomization to death due to any cause, up to 58 months
Secondary	Overall Survival, Per Protocol Population	Overall survival is defined as the time from randomization until death due to any cause.	From randomization to death due to any cause, up to 58 months
Secondary	Overall Survival, Intention-to-treat Population, Abiraterone as Prior Therapy	Overall survival is defined as the time from randomization until death due to any cause.	From randomization to death due to any cause, up to 58 months
Secondary	Overall Survival, Intention-to-treat Population, Enzalutamide as Prior Therapy	Overall survival is defined as the time from randomization until death due to any cause.	From randomization to death due to any cause, up to 58 months
Secondary	Overall Survival, Intention-to-treat Population, no Prior Abiraterone or Enzalutamide	Overall survival is defined as the time from randomization until death due to any cause.	From randomization to death due to any cause, up to 58 months
Secondary	Radiological Progression-free Survival, Intention-to-treat Population	Progressive disease on bone scans was defined as a minimum of two new lesions. Visceral and nodal disease was evaluated according to RECIST 1.1 with modifications as described in the Statistical Analysis Plan.	Time from randomization to the date of the earliest objective evidence of either radiographic progression of bone lesions, radiographic progression of soft tissue lesions, or death due to any cause, up to 58 months
Secondary	Radiological Progression-free Survival, Per Protocol Population	Progressive disease on bone scans was defined as a minimum of two new lesions. Visceral and nodal disease was evaluated according to RECIST 1.1 with modifications as described in the Statistical Analysis Plan.	Time from randomization to the date of the earliest objective evidence of either radiographic progression of bone lesions, radiographic progression of soft tissue lesions, or death due to any cause, up to 58 months
Secondary	Time to PSA Progression, Intention-to-treat Population	The evidence of PSA progression is defined as: time from randomization to the date of PSA absolute increase = 2 ng/mL and = 25% above nadir or baseline values confirmed by a second consecutive value obtained at least 3 weeks later.	Time from randomization to the date of objective evidence of PSA progression (PSA absolute increase = 2 ng/mL and = 25% above nadir or baseline values providing confirmation by a second consecutive value obtained at least 3 weeks later), up to 39 months
Secondary	Time to PSA Progression, Per Protocol Population	The evidence of PSA progression is defined as: time from randomization to the date of PSA absolute increase = 2 ng/mL and = 25% above nadir or baseline values confirmed by a second consecutive value obtained at least 3 weeks later.	Time from randomization to the date of objective evidence of PSA progression (PSA absolute increase = 2 ng/mL and = 25% above nadir or baseline values providing confirmation by a second consecutive value obtained at least 3 weeks later), up to 39 months
Secondary	Time to First Skeletal-related Event, Intention-to-treat Population	Skeletal-related events included: Radiation therapy to bone; Pathologic bone fracture; Spinal cord compression; Surgery to bone; Change in antineoplastic therapy to treat bone pain	Time from randomization to the date of the first skeletal-related event, up to 58 months
Secondary	Time to First Skeletal-related Event, Per Protocol Population	Skeletal-related events included: Radiation therapy to bone; Pathologic bone fracture; Spinal cord compression; Surgery to bone; Change in antineoplastic therapy to treat bone pain	Time from randomization to the date of the first skeletal-related event, up to 58 months
Secondary	Time to Radiological Progression or Skeletal-related Event, Intention-to-treat Population	Progressive disease on bone scans defined as a minimum of two new lesions. Visceral and nodal disease was evaluated according to RECIST 1.1 with modifications as described in the Statistical Analysis Plan.; Skeletal-related events included: Radiation therapy to bone; Pathologic bone fracture; Spinal cord compression; Surgery to bone; Change in antineoplastic therapy to treat bone pain	Time from randomization to the date of the first radiological progression or skeletal-related event, up to 58 months
Secondary	Time to Radiological Progression or Skeletal-related Event, Per Protocol Population	Progressive disease on bone scans defined as a minimum of two new lesions. Visceral and nodal disease was evaluated according to RECIST 1.1 with modifications as described in the Statistical Analysis Plan.; Skeletal-related events included: Radiation therapy to bone; Pathologic bone fracture; Spinal cord compression; Surgery to bone; Change in antineoplastic therapy to treat bone pain	Time from randomization to the date of the first radiological progression or skeletal-related event, up to 58 months
Secondary	Proportion of Patients With Skeletal-related Events, Intention-to-treat Population	Progressive disease on bone scans defined as a minimum of two new lesions. Visceral and nodal disease was evaluated according to RECIST 1.1 with modifications as described in the Statistical Analysis Plan.; Skeletal-related events included: Radiation therapy to bone; Pathologic bone fracture; Spinal cord compression; Surgery to bone; Change in antineoplastic therapy to treat bone pain	From randomization to the end of the study, up to 57 months
Secondary	Proportion of Patients With Skeletal-related Events, Per Protocol Population	Progressive disease on bone scans defined as a minimum of two new lesions. Visceral and nodal disease was evaluated according to RECIST 1.1 with modifications as described in the Statistical Analysis Plan.; Skeletal-related events included: Radiation therapy to bone; Pathologic bone fracture; Spinal cord compression; Surgery to bone; Change in antineoplastic therapy to treat bone pain	From randomization to the end of the study, up to 57 months

External Links

•   Click here for more information about this study: Phase III Study of DCVAC Added to Standard Chemotherapy for Men With Metastatic Castration Resistant Prostate Cancer (VIABLE)