Trial Condition(s):

Hormone Refractory Prostate Cancer, Bone Metastases

A Phase III Study of Radium-223 dichloride in Patients With Symptomatic Hormone Refractory Prostate Cancer With Skeletal Metastases (ALSYMPCA)

Bayer Identifier:

15245

ClinicalTrials.gov Identifier:

NCT00699751

EudraCT Number:

2007-006195-11

Study Completed

Trial Purpose

ALSYMPCA (ALpharadin in SYMPtomatic Prostate CAncer) is an international Phase III clinical study to evaluate the efficacy and safety of Radium-223 dichloride in patients with hormone refractory prostate cancer and skeletal metastases.

Inclusion Criteria
- Histologically or cytologically confirmed adenocarcinoma of the prostate
 - Known hormone refractory disease
 - Multiple skeletal metastases (≥ 2 hot spots) on bone scintigraphy
 - No intention to use cytotoxic chemotherapy within the next 6 months
 - Either regular (not occasional) analgesic medication use for cancer related bone pain or treatment with EBRT (External Beam Radiation Therapy) for bone pain
Exclusion Criteria
- Treatment with an investigational drug within previous 4 weeks, or planned during the treatment period
 - Eligible for first course of docetaxel, i.e. patients who are fit enough, willing and where docetaxel is available
 - Treatment with cytotoxic chemotherapy within previous 4 weeks, or planned during the treatment period, or failure to recover from adverse events due to cytotoxic chemotherapy administered more than 4 weeks ago
 - Systemic radiotherapy with strontium-89, samarium-153, rhenium-186 or rhenium-188 for the treatment of bony metastases within previous 24 weeks
 - Other malignancy treated within the last 5 years (except non-melanoma skin cancer or low-grade superficial bladder cancer)
 - History of visceral metastasis, or visceral metastases as assessed by abdominal/pelvic CT or chest x-ray within previous 8 weeks

Trial Summary

Enrollment Goal
921
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
Yes
Products
Xofigo (Radium-223 dichloride, BAY88-8223)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Universitätsklinikum Hamburg Eppendorf (UKE)

Hamburg, Germany, 20246

Status
Completed
 
Locations

Johannes-Gutenberg-Universität Mainz

Mainz, Germany, 55131

Status
Completed
 
Locations

Universitätsklinik Gießen und Marburg GmbH

Marburg, Germany, 35043

Status
Completed
 
Locations

Kliniken der Medizinischen Hochschule Hannover

Hannover, Germany, 30625

Status
Completed
 
Locations

Vivantes Klinikum Am Urban

Berlin, Germany, 10967

Status
Completed
 
Locations

Universitätsklinikum Ulm

Ulm, Germany, 89075

Status
Completed
 
Locations

Universitätsmedizin der Georg-August-Universität Göttingen

Göttingen, Germany, 37099

Status
Completed
 
Locations

Klinikum Dortmund gGmbH

Dortmund, Germany, 44137

Status
Completed
 
Locations

Klinikum der Johann Wolfgang Goethe Universität Frankfurt

Frankfurt, Germany, 60590

Status
Completed
 
Locations

Urologische Gemeinschaftspraxis

Berlin, Germany, 14197

Status
Completed
 
Locations

Bristol Haematology & Oncology Centre

Bristol, United Kingdom, BS2 8ED

Status
Completed
 
Locations

St James' University Hospital

Leeds, United Kingdom, LS9 7TF

Status
Completed
 
Locations

Royal Derby Hospital

Derby, United Kingdom, DE22 3NE

Status
Completed
 
Locations

Weston Park Hospital

Sheffield, United Kingdom, S10 2SJ

Status
Completed
 
Locations

Castle Hill Hospital

Hull, United Kingdom, HU16 5JQ

Status
Completed
 
Locations

Queens Hospital

Romford, United Kingdom, RM7 0AG

Status
Completed
 
Locations

Musgrove Park Hospital

Taunton, United Kingdom, TA1 5DA

Status
Completed
 
Locations

Southampton General Hospital

Southampton, United Kingdom, SO16 6YD

Status
Completed
 
Locations

Mount Vernon Hospital

Northwood, United Kingdom, HA6 2RN

Status
Completed
 
Locations

CRUK Trials Unit-Institute For Cancer Studies

Birmingham, United Kingdom, B15 2TH

Status
Completed
 
Locations

Royal Surrey County Hospital

Guildford, United Kingdom, GU2 7XX

Status
Completed
 
Locations

Christie Hospital

Manchester, United Kingdom, M20 4BX

Status
Completed
 
Locations

Belfast City Hospital

Belfast, United Kingdom, BT9 7AB

Status
Completed
 
Locations

Royal Marsden NHS Trust (Surrey)

Sutton, United Kingdom, SM2 5PT

Status
Completed
 
Locations

Derriford Hospital

Plymouth, United Kingdom, PL6 8DH

Status
Completed
 
Locations

New Cross Hospital

Wolverhampton, United Kingdom, WV10 0QP

Status
Completed
 
Locations

Royal Sussex County Hospital

Brighton, United Kingdom, BN2 5BD

Status
Completed
 
Locations

Ipswich District NHS Hospital

Ipswich, United Kingdom, IP4 5PD

Status
Completed
 
Locations

Velindre Hospital

Cardiff, United Kingdom

Status
Completed
 
Locations

University Hospital

Coventry, United Kingdom, CV2 2DX

Status
Completed
 
Locations

Nottingham City Hospital

Nottingham, United Kingdom, NG5 1PB

Status
Completed
 
Locations

Clatterbridge Centre for Oncology

Bebington, United Kingdom, CH63 4JY

Status
Completed
 
Locations

Leicester Royal Infirmary

Leicester, United Kingdom, LE1 5WW

Status
Completed
 
Locations

Fox Chase Cancer Center

Philadelphia, United States, 19111-2497

Status
Completed
 
Locations

Washington University School of Medicine

St. Louis, United States, 63110

Status
Completed
 
Locations

Cedars- Sinai Medical Center

Los Angeles, United States, 90048-0750

Status
Completed
 
Locations

Tulane University School of Medicine

New Orleans, United States, 70112

Status
Completed
 
Locations

Sutter Roseville Medical Center

Roseville, United States, 95661

Status
Completed
 
Locations

H. Lee Moffitt Cancer Center & Research Institute

Tampa, United States, 33612

Status
Completed
 
Locations

Comprehensive Cancer Centers of Nevada

Las Vegas, United States, 89169

Status
Completed
 
Locations

Centre Hospitalier André Boulloche - Montbeliard

MONTBELIARD, France, 25209

Status
Completed
 
Locations

Institue Curie - Centre René Huguenin

SAINT CLOUD, France, 92210

Status
Completed
 
Locations

Centre Hospitalier Départemental-La Roche sur Yon

LA ROCHE SUR YON, France, 85925

Status
Completed
 
Locations

Swietokrzyskie Centrum Onkologii

Kielce, Poland, 25-734

Status
Completed
 
Locations

Centrum Onkologii - Instytut

Gliwice, Poland, 44-101

Status
Completed
 
Locations

Szpital Uniwersytecki Nr 2 im. J. Bizela

Bydgoszcz, Poland, 85-165

Status
Completed
 
Locations

Samodzielny Publiczny Szpital Kliniczny nr 4

Luiblin, Poland, 20-954

Status
Completed
 
Locations

IV Wojskowy Szpital Kliniczny z Poliklinika, SPZOZ

Wroclaw, Poland, 50-981

Status
Completed
 
Locations

Szpital Uniwersytecki w Krakowie

Krakow, Poland, 31-051

Status
Completed
 
Locations

Centrum Onkologii - Instytut im. M.Sklodowskiej-Curie

Warszawa, Poland, 02-781

Status
Completed
 
Locations

Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego

Wroclaw, Poland, 50 - 556

Status
Completed
 
Locations

IRCCS Fondazione del Piemonte per l'Oncologia

Candiolo, Italy, 10060

Status
Completed
 
Locations

IRST Istituto Scientifico Romagnolo per studio e cura Tumori

Meldola, Italy, 47014

Status
Completed
 
Locations

A.O. Ospedali Riuniti Bergamo

Bergamo, Italy, 24128

Status
Completed
 
Locations

A.O. Ospedale Niguarda Ca' Granda

Milano, Italy, 20162

Status
Completed
 
Locations

A.O. di Reggio Emilia

Reggio Emilia, Italy, 42123

Status
Completed
 
Locations

Hospital Reina Sofía

Córdoba, Spain, 14004

Status
Completed
 
Locations

Clínica Universidad de Navarra CUN

Pamplona, Spain, 31008

Status
Completed
 
Locations

Hospital Universitari i Politècnic La Fe

Valencia, Spain, 46026

Status
Completed
 
Locations

Ciutat Sanitària i Universitaria de la Vall d'Hebron

Barcelona, Spain, 08035

Status
Completed
 
Locations

Hospital de la Santa Creu i de Sant Pau

Barcelona, Spain, 08025

Status
Completed
 
Locations

Hospital de Cruces

Barakaldo, Spain, 48903

Status
Completed
 
Locations

Hospital Clínico Universitario de Santiago de Compostela

Santiago de Compostela, Spain, 15706

Status
Completed
 
Locations

Hospital Clínic i Provincial de Barcelona

Barcelona, Spain, 08036

Status
Completed
 
Locations

Hospital Clínico Universitario Lozano Blesa

Zaragoza, Spain, 50009

Status
Completed
 
Locations

Sunnybrook Health Sciences Centre

Toronto, Canada, M4N 3M5

Status
Completed
 
Locations

Ottawa Hospital-General Campus

Ottawa, Canada, K1H 8L6

Status
Completed
 
Locations

Cross Cancer Institute

Edmonton, Canada, T6G 1Z2

Status
Completed
 
Locations

London Health Sciences Centre

London, Canada, N6A 4G5

Status
Completed
 
Locations

AZ Groeninge Campus Vercruysselaan

KORTRIJK, Belgium, 8500

Status
Completed
 
Locations

Clinique Saint-Pierre

OTTIGNIES, Belgium, 1340

Status
Completed
 
Locations

Medisch Centrum Alkmaar

ALKMAAR, Netherlands, 1815 JD

Status
Completed
 
Locations

Canisius Wilhelmina Ziekenhuis

NIJMEGEN, Netherlands, 6532 SZ

Status
Completed
 
Locations

Erasmus Medisch Centrum

ROTTERDAM, Netherlands, 3015 CE

Status
Completed
 
Locations

Oslo universitetssykehus HF Radiumhospitalet

Oslo, Norway, N-0310

Status
Completed
 
Locations

Helse Bergen HF Haukeland universitetssjukehus

Bergen, Norway, 5021

Status
Completed
 
Locations

Oslo Universitetssykehus HF, Ullevål

Oslo, Norway, 0450

Status
Completed
 
Locations

Sørlandet sykehus HF Kristiansand

Kristiansand, Norway, N-4604

Status
Completed
 
Locations

Helse Møre og Romsdal HF

Ålesund, Norway, 6026

Status
Completed
 
Locations

Universitetssykehuset Nord-Norge HF Tromsø

Tromsø, Norway, 9038

Status
Completed
 
Locations

Nordlandssykehuset HF

Bodø, Norway, 8092

Status
Completed
 
Locations

St Olavs Hospital HF

Trondheim, Norway, 7006

Status
Completed
 
Locations

Nemocnice Chomutov, o.z.

Chomutov, Czech Republic, 430 12

Status
Completed
 
Locations

Fakultni nemocnice Ostrava

Ostrava, Czech Republic, 708 52

Status
Completed
 
Locations

Fakultni nemocnice Plzen

Plzen - Bory, Czech Republic, 305 99

Status
Completed
 
Locations

Masarykuv onkologicky ustav

Brno, Czech Republic, 65653

Status
Completed
 
Locations

Fakultni Nemocnice Olomouc

Olomouc, Czech Republic, 775 20

Status
Completed
 
Locations

Masaryk Hospital Usti n/L

Usti nad Labem, Czech Republic, 401 13

Status
Completed
 
Locations

Fakultni Thomayerova Nemocnice

Praha 4, Czech Republic, 140 59

Status
Completed
 
Locations

Tel-Aviv Sourasky Medical Center

Tel Aviv, Israel, 6423906

Status
Completed
 
Locations

Meir Medical Center

Kfar Saba, Israel, 4428164

Status
Completed
 
Locations

Soroka University Medical Center

Beer Sheva, Israel, 8410101

Status
Completed
 
Locations

Assaf Harofeh Medical Center

Zrifin, Israel, 6093000

Status
Completed
 
Locations

Royal Adelaide Hospital

Adelaide, Australia, 5000

Status
Completed
 
Locations

St Vincents Hospital Sydney

Sydney, Australia, 2010

Status
Completed
 
Locations

Royal Brisbane and Women's Hospital

Brisbane, Australia, 4029

Status
Completed
 
Locations

St Vincents Hospital

Fitzroy, Australia, 3065

Status
Completed
 
Locations

Royal Hobart Hospital

Hobart, Australia, 7000

Status
Completed
 
Locations

Prince of Wales Hospital

Randwick, Australia, 2031

Status
Completed
 
Locations

Royal North Shore Hospital

St Leonards, Australia, 2065

Status
Completed
 
Locations

Toowoomba Cancer Research Centre

Toowoomba, Australia, 4350

Status
Completed
 
Locations

Wollongong Hospital

Wollongong, Australia, 2521

Status
Completed
 
Locations

Queen Elizabeth Hospital

Adelaide, Australia, 5011

Status
Completed
 
Locations

Liverpool Hospital

Liverpool, Australia, 2170

Status
Completed
 
Locations

Sir Charles Gairdner Hospital

Nedlands, Australia, 6009

Status
Completed
 
Locations

Sydney Adventist Hospital

Wahroonga, Australia, 2076

Status
Completed
 
Locations

Hospital Luxemburgo

Belo Horizonte, Brazil, 30380490

Status
Completed
 
Locations

Hospital das Clínicas da Faculdade de Medicina da USP

Sao Paulo, Brazil, 05403-900

Status
Completed
 
Locations

Hospital Universitario Pedro Ernesto

Rio de Janeiro, Brazil, 20551 030

Status
Completed
 
Locations

Hospital de Clínicas de Porto Alegre

Porto Alegre, Brazil

Status
Completed
 
Locations

Santa Casa de Misericórdia de Piracicaba

Piracicaba, Brazil

Status
Completed
 
Locations

Hospital Lifecenter

Belo Horizonte, Brazil, 30110-090

Status
Completed
 
Locations

Assistência Multidisciplinar em Oncologia (AMO)

Salvador, Brazil, 41830-492

Status
Completed
 
Locations

Fundação Pio XII – Hospital de Câncer de Barretos

Barretos, Brazil, 14784400

Status
Completed
 
Locations

Faculty Hospital F. D. Roosevelt

Banska Bystrica, Slovakia, 97517

Status
Completed
 
Locations

Dererova nemocnica s poliklinikou

Bratislava, Slovakia, 83305

Status
Completed
 
Locations

Univerzitna nemocnica Bratislava, Nemocnica Ruzinov

Bratislava, Slovakia, 82606

Status
Completed
 
Locations

URO Centrum s.r.o.

Trnava, Slovakia, 917 01

Status
Completed
 
Locations

Univerzitna nemocnica Martin

Martin, Slovakia, 03659

Status
Completed
 
Locations

Fakultna nemocnica s poliklinikou J.A. Reimana

Presov, Slovakia, 08181

Status
Completed
 
Locations

Queen Mary Hospital

Hong Kong, Hong Kong, China

Status
Completed
 
Locations

Queen Elizabeth Hospital

Kowloon, Hong Kong, China

Status
Completed
 
Locations

Pamela Youde Nethersole Eastern Hospital

Chai Wan, Hong Kong, China

Status
Completed
 
Locations

Tuen Mun Hospital

Hongkong, Hong Kong, China

Status
Completed
 
Locations

Tan Tock Seng Hospital

Singapore, Singapore, 308433

Status
Completed
 
Locations

OncoCare Cancer Centre

Singapore, Singapore, 258499

Status
Completed
 
Locations

Fundación Hospital Alcorcón

Alcorcón, Spain, 28922

Status
Completed
 
Locations

Länssjukhuset Sundsvall-Härnösand

Sundsvall, Sweden, 851 86

Status
Completed
 
Locations

Länssjukhuset i Kalmar

Kalmar, Sweden, 391 85

Status
Completed
 
Locations

Ryhov Hospital

Jönköping, Sweden, 551 85

Status
Completed
 
Locations

Sahlgrenska Universitetssjukhuset

Göteborg, Sweden, 413 45

Status
Completed
 
Locations

Norrlands Universitetssjukhus, Umeå

Umeå, Sweden, 901 85

Status
Completed
 
Locations

Karolinska Universitetssjukhuset i Solna

Stockholm, Sweden, 171 76

Status
Completed
 
Locations

Länssjukhuset Gävle-Sandviken

Sandviken, Sweden, 80187

Status
Completed
 
Locations

Universitetssjukhuset MAS

Malmö, Sweden, 205 02

Status
Completed
 

Trial Design