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:
EudraCT Number:
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Universitätsklinikum Hamburg Eppendorf (UKE) Hamburg, Germany, 20246 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Johannes-Gutenberg-Universität Mainz Mainz, Germany, 55131 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinik Gießen und Marburg GmbH Marburg, Germany, 35043 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kliniken der Medizinischen Hochschule Hannover Hannover, Germany, 30625 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Vivantes Klinikum Am Urban Berlin, Germany, 10967 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Ulm Ulm, Germany, 89075 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsmedizin der Georg-August-Universität Göttingen Göttingen, Germany, 37099 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum Dortmund gGmbH Dortmund, Germany, 44137 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum der Johann Wolfgang Goethe Universität Frankfurt Frankfurt, Germany, 60590 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Urologische Gemeinschaftspraxis Berlin, Germany, 14197 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Bristol Haematology & Oncology Centre Bristol, United Kingdom, BS2 8ED | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St James' University Hospital Leeds, United Kingdom, LS9 7TF | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Royal Derby Hospital Derby, United Kingdom, DE22 3NE | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Weston Park Hospital Sheffield, United Kingdom, S10 2SJ | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Castle Hill Hospital Hull, United Kingdom, HU16 5JQ | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Queens Hospital Romford, United Kingdom, RM7 0AG | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Musgrove Park Hospital Taunton, United Kingdom, TA1 5DA | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Southampton General Hospital Southampton, United Kingdom, SO16 6YD | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Mount Vernon Hospital Northwood, United Kingdom, HA6 2RN | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CRUK Trials Unit-Institute For Cancer Studies Birmingham, United Kingdom, B15 2TH | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Royal Surrey County Hospital Guildford, United Kingdom, GU2 7XX | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Christie Hospital Manchester, United Kingdom, M20 4BX | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Belfast City Hospital Belfast, United Kingdom, BT9 7AB | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Royal Marsden NHS Trust (Surrey) Sutton, United Kingdom, SM2 5PT | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Derriford Hospital Plymouth, United Kingdom, PL6 8DH | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations New Cross Hospital Wolverhampton, United Kingdom, WV10 0QP | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Royal Sussex County Hospital Brighton, United Kingdom, BN2 5BD | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ipswich District NHS Hospital Ipswich, United Kingdom, IP4 5PD | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Velindre Hospital Cardiff, United Kingdom | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University Hospital Coventry, United Kingdom, CV2 2DX | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Nottingham City Hospital Nottingham, United Kingdom, NG5 1PB | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clatterbridge Centre for Oncology Bebington, United Kingdom, CH63 4JY | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Leicester Royal Infirmary Leicester, United Kingdom, LE1 5WW | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Fox Chase Cancer Center Philadelphia, United States, 19111-2497 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Washington University School of Medicine St. Louis, United States, 63110 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cedars- Sinai Medical Center Los Angeles, United States, 90048-0750 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tulane University School of Medicine New Orleans, United States, 70112 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sutter Roseville Medical Center Roseville, United States, 95661 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations H. Lee Moffitt Cancer Center & Research Institute Tampa, United States, 33612 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Comprehensive Cancer Centers of Nevada Las Vegas, United States, 89169 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre Hospitalier André Boulloche - Montbeliard MONTBELIARD, France, 25209 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Institue Curie - Centre René Huguenin SAINT CLOUD, France, 92210 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre Hospitalier Départemental-La Roche sur Yon LA ROCHE SUR YON, France, 85925 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Swietokrzyskie Centrum Onkologii Kielce, Poland, 25-734 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centrum Onkologii - Instytut Gliwice, Poland, 44-101 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Szpital Uniwersytecki Nr 2 im. J. Bizela Bydgoszcz, Poland, 85-165 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Samodzielny Publiczny Szpital Kliniczny nr 4 Luiblin, Poland, 20-954 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IV Wojskowy Szpital Kliniczny z Poliklinika, SPZOZ Wroclaw, Poland, 50-981 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Szpital Uniwersytecki w Krakowie Krakow, Poland, 31-051 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centrum Onkologii - Instytut im. M.Sklodowskiej-Curie Warszawa, Poland, 02-781 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego Wroclaw, Poland, 50 - 556 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IRCCS Fondazione del Piemonte per l'Oncologia Candiolo, Italy, 10060 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IRST Istituto Scientifico Romagnolo per studio e cura Tumori Meldola, Italy, 47014 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. Ospedali Riuniti Bergamo Bergamo, Italy, 24128 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. Ospedale Niguarda Ca' Granda Milano, Italy, 20162 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. di Reggio Emilia Reggio Emilia, Italy, 42123 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Reina Sofía Córdoba, Spain, 14004 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clínica Universidad de Navarra CUN Pamplona, Spain, 31008 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Universitari i Politècnic La Fe Valencia, Spain, 46026 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ciutat Sanitària i Universitaria de la Vall d'Hebron Barcelona, Spain, 08035 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital de la Santa Creu i de Sant Pau Barcelona, Spain, 08025 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital de Cruces Barakaldo, Spain, 48903 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Clínico Universitario de Santiago de Compostela Santiago de Compostela, Spain, 15706 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Clínic i Provincial de Barcelona Barcelona, Spain, 08036 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Clínico Universitario Lozano Blesa Zaragoza, Spain, 50009 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sunnybrook Health Sciences Centre Toronto, Canada, M4N 3M5 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ottawa Hospital-General Campus Ottawa, Canada, K1H 8L6 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cross Cancer Institute Edmonton, Canada, T6G 1Z2 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations London Health Sciences Centre London, Canada, N6A 4G5 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations AZ Groeninge Campus Vercruysselaan KORTRIJK, Belgium, 8500 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinique Saint-Pierre OTTIGNIES, Belgium, 1340 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medisch Centrum Alkmaar ALKMAAR, Netherlands, 1815 JD | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Canisius Wilhelmina Ziekenhuis NIJMEGEN, Netherlands, 6532 SZ | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Erasmus Medisch Centrum ROTTERDAM, Netherlands, 3015 CE | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Oslo universitetssykehus HF Radiumhospitalet Oslo, Norway, N-0310 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Helse Bergen HF Haukeland universitetssjukehus Bergen, Norway, 5021 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Oslo Universitetssykehus HF, Ullevål Oslo, Norway, 0450 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sørlandet sykehus HF Kristiansand Kristiansand, Norway, N-4604 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Helse Møre og Romsdal HF Ålesund, Norway, 6026 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitetssykehuset Nord-Norge HF Tromsø Tromsø, Norway, 9038 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Nordlandssykehuset HF Bodø, Norway, 8092 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St Olavs Hospital HF Trondheim, Norway, 7006 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Nemocnice Chomutov, o.z. Chomutov, Czech Republic, 430 12 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Fakultni nemocnice Ostrava Ostrava, Czech Republic, 708 52 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Fakultni nemocnice Plzen Plzen - Bory, Czech Republic, 305 99 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Masarykuv onkologicky ustav Brno, Czech Republic, 65653 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Fakultni Nemocnice Olomouc Olomouc, Czech Republic, 775 20 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Masaryk Hospital Usti n/L Usti nad Labem, Czech Republic, 401 13 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Fakultni Thomayerova Nemocnice Praha 4, Czech Republic, 140 59 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tel-Aviv Sourasky Medical Center Tel Aviv, Israel, 6423906 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Meir Medical Center Kfar Saba, Israel, 4428164 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Soroka University Medical Center Beer Sheva, Israel, 8410101 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Assaf Harofeh Medical Center Zrifin, Israel, 6093000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Royal Adelaide Hospital Adelaide, Australia, 5000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St Vincents Hospital Sydney Sydney, Australia, 2010 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Royal Brisbane and Women's Hospital Brisbane, Australia, 4029 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St Vincents Hospital Fitzroy, Australia, 3065 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Royal Hobart Hospital Hobart, Australia, 7000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Prince of Wales Hospital Randwick, Australia, 2031 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Royal North Shore Hospital St Leonards, Australia, 2065 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Toowoomba Cancer Research Centre Toowoomba, Australia, 4350 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Wollongong Hospital Wollongong, Australia, 2521 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Queen Elizabeth Hospital Adelaide, Australia, 5011 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Liverpool Hospital Liverpool, Australia, 2170 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sir Charles Gairdner Hospital Nedlands, Australia, 6009 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sydney Adventist Hospital Wahroonga, Australia, 2076 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Luxemburgo Belo Horizonte, Brazil, 30380490 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital das Clínicas da Faculdade de Medicina da USP Sao Paulo, Brazil, 05403-900 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Universitario Pedro Ernesto Rio de Janeiro, Brazil, 20551 030 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital de Clínicas de Porto Alegre Porto Alegre, Brazil | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Santa Casa de Misericórdia de Piracicaba Piracicaba, Brazil | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Lifecenter Belo Horizonte, Brazil, 30110-090 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Assistência Multidisciplinar em Oncologia (AMO) Salvador, Brazil, 41830-492 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Fundação Pio XII – Hospital de Câncer de Barretos Barretos, Brazil, 14784400 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Faculty Hospital F. D. Roosevelt Banska Bystrica, Slovakia, 97517 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dererova nemocnica s poliklinikou Bratislava, Slovakia, 83305 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Univerzitna nemocnica Bratislava, Nemocnica Ruzinov Bratislava, Slovakia, 82606 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations URO Centrum s.r.o. Trnava, Slovakia, 917 01 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Univerzitna nemocnica Martin Martin, Slovakia, 03659 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Fakultna nemocnica s poliklinikou J.A. Reimana Presov, Slovakia, 08181 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Queen Mary Hospital Hong Kong, Hong Kong, China | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Queen Elizabeth Hospital Kowloon, Hong Kong, China | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Pamela Youde Nethersole Eastern Hospital Chai Wan, Hong Kong, China | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tuen Mun Hospital Hongkong, Hong Kong, China | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tan Tock Seng Hospital Singapore, Singapore, 308433 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations OncoCare Cancer Centre Singapore, Singapore, 258499 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Fundación Hospital Alcorcón Alcorcón, Spain, 28922 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Länssjukhuset Sundsvall-Härnösand Sundsvall, Sweden, 851 86 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Länssjukhuset i Kalmar Kalmar, Sweden, 391 85 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ryhov Hospital Jönköping, Sweden, 551 85 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sahlgrenska Universitetssjukhuset Göteborg, Sweden, 413 45 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Norrlands Universitetssjukhus, Umeå Umeå, Sweden, 901 85 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Karolinska Universitetssjukhuset i Solna Stockholm, Sweden, 171 76 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Länssjukhuset Gävle-Sandviken Sandviken, Sweden, 80187 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitetssjukhuset MAS Malmö, Sweden, 205 02 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A Double-blind, Randomised, Multiple Dose, Phase III, Multicentre Study of Alpharadin in the Treatment of Patients With Symptomatic Hormone Refractory Prostate Cancer With Skeletal Metastases
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Overall survivalOverall survival was defined as the time from date of randomization to the date of death.Timeframe: From randomization to death due to any cause until approximately 3 years after start of enrollment, the data was collected up to the second data analysis date (15 JUL 2011)
Secondary Outcome
- Time to total Alkaline Phosphatase (ALP) progressionThe time from the first study drug administration to when ALP progression was observed, defined as: 1) In subjects with no ALP decline from baseline; a greater than or equal to 25% increase from baseline value and an increase in absolute value of greater than or equal to 2 ng/mL, at least 12 weeks from baseline; 2) In subjects with initial ALP decline from baseline; the time from start of treatment to first ALP increase that is greater than or equal to 25% increase and at least 2 ng/mL above the nadir value, which was confirmed by a second value obtained 3 or more weeks laterTimeframe: From randomization to first ALP progression until approximately 3 years after start of enrollment
- Percentage of Participants with Total ALP response at Week 12ALP levels were measured in participants' blood at Week 12 and compared to baseline values. A confirmed total ALP response (either >/= 30% or 50% reduction from baseline) was confirmed by a second total ALP value approximately 4 weeks later.Timeframe: At Baseline and Week 12
- Percentage of Participants with Total ALP response at End of Treatment (EOT; Week 24 or at the time the patient dies or discontinues treatment phase)ALP levels were measured in participants' blood at EOT (Week 24) and compared to baseline values. A confirmed total ALP response (>/=50% reduction from baseline) was confirmed by a second total ALP value approximately 4 weeks later.Timeframe: At Baseline and End of Treatment (Week 24 or at the time the patient dies or discontinues treatment phase)
- Percentage of Participants with Total ALP normalization at Week 12The return of total ALP value to within normal range at 12 weeks in 2 consecutive measurements (at least 2 weeks apart) after start of treatment in subjects who had ALP above the upper limit of normal (ULN) at baseline.Timeframe: At Baseline and Week 12
- Percentage change from baseline in total ALP at Week 12ALP level was measured in subject's blood at Week 12 and the percent change from the baseline value was calculated (ALP level at week 12 minus ALP level at baseline)/(ALP level at baseline)*100Timeframe: At Baseline and Week 12
- Maximum Percentage Decrease from baseline in total ALP up to Week 12ALP level was measured in participant's blood up to week 12 and the maximum percent decrease from the baseline up to Week 12 value was calculated as the minimum value of [(ALP level up to week 12 minus ALP level at baseline)/(ALP level at baseline)*100] by participant, and set to zero if no decrease from baseline.Timeframe: From baseline to Week 12
- Percentage change from baseline in total ALP at EOT (Week 24 or at the time the patient dies or discontinues treatment phase)ALP level was measured in subject's blood at EOT (Week 24) and the percent change from the baseline value was calculated (ALP level at EOT minus ALP level at baseline)/(ALP level at baseline)*100Timeframe: At Baseline and End of Treatment (Week 24 or at the time the patient dies or discontinues treatment phase)
- Maximum Percentage decrease from baseline in total ALP During the 24 Week TreatmentALP level was measured in participant's blood during the 24 week treatment (up to EOT) and the maximum percent decrease from baseline during the 24 week treatment value was calculated as the minimum value of [(ALP level up to week 24 minus ALP level at baseline)/(ALP level at baseline)*100] by participant, and set to zero if no decrease from baseline.Timeframe: From baseline During the 24 Week Treatment
- Time to Prostate Specific Antigen (PSA) progressionThe time from the first study drug administration to when PSA progression was observed, defined as: 1) In subjects with no PSA decline from baseline; a greater than or equal to 25% increase from baseline value and an increase in absolute value of greater than or equal to 2 ng/mL, at least 12 weeks from baseline; 2) In subjects with initial PSA decline from baseline; the time from start of treatment to first PSA increase that is greater than or equal to 25% increase and at least 2 ng/mL above the nadir value, which was confirmed by a second value obtained 3 or more weeks laterTimeframe: From randomization to first PSA progression until approximately 3 years after start of enrollment
- Percentage of Participants with PSA response at Week 12PSA levels were measured in participants' blood at Week 12 and compared to baseline values. A confirmed PSA response (>/=50% reduction from baseline) was confirmed by a second PSA value approximately 4 weeks later.Timeframe: At Baseline and Week 12
- Percentage of Participants with PSA response at EOT (Week 24 or at the time the patient dies or discontinues treatment phase)PSA levels were measured in participants' blood at EOT (Week 24) and compared to baseline values. A confirmed PSA response (>/=50% reduction from baseline) was confirmed by a second PSA value approximately 4 weeks later.Timeframe: At Baseline and End of Treatment (Week 24 or at the time the patient dies or discontinues treatment phase)
- Percentage change from baseline in PSA at Week 12PSA level was measured in subject's blood at Week 12 and the percent change from the baseline value was calculated (PSA level at week 12 minus PSA level at baseline)/(PSA level at baseline)*100Timeframe: At Baseline and Week 12
- Maximum Percentage Decrease from baseline in PSA up to Week 12PSA level was measured in participant's blood up to Week 12 and the maximum percent decrease from the baseline up to week 12 value was calculated as the minimum value of [(PSA level up to week 12 minus PSA level at baseline)/(PSA level at baseline)*100] by participant, and set to zero if no decrease from baseline.Timeframe: From baseline up to Week 12
- Percentage change from baseline in PSA at EOT (Week 24 or at the time the patient dies or discontinues treatment phase)PSA level was measured in subject’s blood at EOT (Week 24) and the percent change from the baseline value was calculated (PSA level at EOT minus PSA level at baseline)/(PSA level at baseline)*100Timeframe: At Baseline and End of Treatment (Week 24 or at the time the patient dies or discontinues treatment phase)
- Maximum Percentage Decrease from Baseline in PSA response During the 24 Week Treatment PeriodPSA level was measured in participant's blood during the 24 week treatment (up to EOT) and the maximum percent decrease from baseline during the 24 Week treatment value was calculated as the minimum value of [(PSA level up to week 24 minus PSA level at baseline)/(PSA level at baseline)*100] by participant, and set to zero if no decrease from baseline.Timeframe: From baseline to End of Treatment (Week 24; 4 weeks post last injection)
- Time to first Skeletal Related Event (SRE)A skeletal related event is the use of external beam radiotherapy to relieve skeletal symptoms or the occurrence of new symptomatic pathological bone fractures (vertebral or non-vertebral) or the occurrence of spinal cord compression or a tumour related orthopaedic surgical intervention. For all other events, the start date of the event/medication/therapy was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.Timeframe: From randomization to first first SRE until approximately 3 years after start of enrollment
- Time to occurrence of first use of External Beam Radiation Therapy (EBRT) to relieve skeletal symptomsThe start date of therapy was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.Timeframe: From randomization to first EBRT until approximately 3 years after start of enrollment
- Time to occurrence of first use of radioisotopes to relieve skeletal symptomsThe start date of the radioisotopes was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.Timeframe: From randomization to first use of radioisotopes until approximately 3 years after start of enrollment
- Time to occurrence of first new symptomatic pathological bone fractures, vertebral and non-vertebralThe start date of the event was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.Timeframe: From randomization to occurrence of first new symptomatic pathological bone fractures until approximately 3 years after start of enrollment
- Time to occurrence of first tumor related orthopedic surgical interventionThe start date of the intervention was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.Timeframe: From randomization to occurrence of first tumor related orthopedic surgical intervention until approximately 3 years after start of enrollment
- Time to occurrence of first spinal cord compressionThe start date of the compression was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.Timeframe: From randomization to first spinal cord compression until approximately 3 years after start of enrollment
- Time to occurrence of first start of any other anti-cancer treatmentThe start date of the treatment was used as the time of the event. If an event has not occurred at the time of the analysis or the patient has been lost to follow-up, the time-to-event variables will be censored at the last disease assessment date.Timeframe: From randomization to first start of any other anti-cancer treatment until approximately 3 years after start of enrollment
- Time to occurrence of first deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) by at least 2 points from baselineECOG scores were: 0 = fully active; 1 = restricted in physically strenuous activity; 2 = ambulatory and capable of all self-care but unable to work; 3 = capable of only limited self-care; 4 = completely disabled; 5 = death. The visit at which a 2-point or more deterioration in PS was observed was the time of the event. ECOG was assessed at every visit. If a marked deterioration in PS has not occurred at the time of the analysis or the participant was lost to follow-up, the time-to-event variables were censored at the last assessment date.Timeframe: From randomization to first deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) until approximately 3 years after start of enrollment
Additional Information
Copyright © Bayer
Powered by
