Study Completed

Hormone Refractory Prostate Cancer, Bone Metastases

Bayer Identifier:

15245

ClinicalTrials.gov Identifier:

NCT00699751

EudraCT Number:

2007-006195-11

EU CT Number:

Not Available

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

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.

Key Participants Requirements

Sex

Male

Age

18 - N/A

Trial summary

Enrollment Goal

921

Trial Dates

June 2008 - February 2014

Phase

Phase 3

Could I Receive a placebo

Yes

Products

Xofigo (Radium-223 dichloride, BAY88-8223)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	Universitätsklinikum Hamburg Eppendorf (UKE)	Hamburg, 20246, Germany
Completed	Johannes-Gutenberg-Universität Mainz	Mainz, 55131, Germany
Completed	Universitätsklinik Gießen und Marburg GmbH	Marburg, 35043, Germany
Completed	Kliniken der Medizinischen Hochschule Hannover	Hannover, 30625, Germany
Completed	Vivantes Klinikum Am Urban	Berlin, 10967, Germany
Completed	Universitätsklinikum Ulm	Ulm, 89075, Germany
Completed	Universitätsmedizin der Georg-August-Universität Göttingen	Göttingen, 37099, Germany
Completed	Klinikum Dortmund gGmbH	Dortmund, 44137, Germany
Completed	Klinikum der Johann Wolfgang Goethe Universität Frankfurt	Frankfurt, 60590, Germany
Completed	Urologische Gemeinschaftspraxis	Berlin, 14197, Germany
Completed	Bristol Haematology & Oncology Centre	Bristol, BS2 8ED, United Kingdom
Completed	St James' University Hospital	Leeds, LS9 7TF, United Kingdom
Completed	Royal Derby Hospital	Derby, DE22 3NE, United Kingdom
Completed	Weston Park Hospital	Sheffield, S10 2SJ, United Kingdom
Completed	Castle Hill Hospital	Hull, HU16 5JQ, United Kingdom
Completed	Queens Hospital	Romford, RM7 0AG, United Kingdom
Completed	Musgrove Park Hospital	Taunton, TA1 5DA, United Kingdom
Completed	Southampton General Hospital	Southampton, SO16 6YD, United Kingdom
Completed	Mount Vernon Hospital	Northwood, HA6 2RN, United Kingdom
Completed	CRUK Trials Unit-Institute For Cancer Studies	Birmingham, B15 2TH, United Kingdom
Completed	Royal Surrey County Hospital	Guildford, GU2 7XX, United Kingdom
Completed	Christie Hospital	Manchester, M20 4BX, United Kingdom
Completed	Belfast City Hospital	Belfast, BT9 7AB, United Kingdom
Completed	Royal Marsden NHS Trust (Surrey)	Sutton, SM2 5PT, United Kingdom
Completed	Derriford Hospital	Plymouth, PL6 8DH, United Kingdom
Completed	New Cross Hospital	Wolverhampton, WV10 0QP, United Kingdom
Completed	Royal Sussex County Hospital	Brighton, BN2 5BD, United Kingdom
Completed	Ipswich District NHS Hospital	Ipswich, IP4 5PD, United Kingdom
Completed	Velindre Hospital	Cardiff, United Kingdom
Completed	University Hospital	Coventry, CV2 2DX, United Kingdom
Completed	Nottingham City Hospital	Nottingham, NG5 1PB, United Kingdom
Completed	Clatterbridge Centre for Oncology	Bebington, CH63 4JY, United Kingdom
Completed	Leicester Royal Infirmary	Leicester, LE1 5WW, United Kingdom
Completed	Fox Chase Cancer Center	Philadelphia, 19111-2497, United States
Completed	Washington University School of Medicine	St. Louis, 63110, United States
Completed	Cedars- Sinai Medical Center	Los Angeles, 90048-0750, United States
Completed	Tulane University School of Medicine	New Orleans, 70112, United States
Completed	Sutter Roseville Medical Center	Roseville, 95661, United States
Completed	H. Lee Moffitt Cancer Center & Research Institute	Tampa, 33612, United States
Completed	Comprehensive Cancer Centers of Nevada	Las Vegas, 89169, United States
Completed	Centre Hospitalier André Boulloche - Montbeliard	MONTBELIARD, 25209, France
Completed	Institue Curie - Centre René Huguenin	SAINT CLOUD, 92210, France
Completed	Centre Hospitalier Départemental-La Roche sur Yon	LA ROCHE SUR YON, 85925, France
Completed	Centre Hospitalier André Boulloche - Montbeliard	MONTBELIARD, 25209, France
Completed	Swietokrzyskie Centrum Onkologii	Kielce, 25-734, Poland
Completed	Centrum Onkologii - Instytut	Gliwice, 44-101, Poland
Completed	Szpital Uniwersytecki Nr 2 im. J. Bizela	Bydgoszcz, 85-165, Poland
Completed	Samodzielny Publiczny Szpital Kliniczny nr 4	Luiblin, 20-954, Poland
Completed	IV Wojskowy Szpital Kliniczny z Poliklinika, SPZOZ	Wroclaw, 50-981, Poland
Completed	Szpital Uniwersytecki w Krakowie	Krakow, 31-051, Poland
Completed	Centrum Onkologii - Instytut im. M.Sklodowskiej-Curie	Warszawa, 02-781, Poland
Completed	Uniwersytecki Szpital Kliniczny im. J. Mikulicza-Radeckiego	Wroclaw, 50 - 556, Poland
Completed	IRCCS Fondazione del Piemonte per l'Oncologia	Candiolo, 10060, Italy
Completed	IRST Istituto Scientifico Romagnolo per studio e cura Tumori	Meldola, 47014, Italy
Completed	A.O. Ospedali Riuniti Bergamo	Bergamo, 24128, Italy
Completed	A.O. Ospedale Niguarda Ca' Granda	Milano, 20162, Italy
Completed	A.O. di Reggio Emilia	Reggio Emilia, 42123, Italy
Completed	Hospital Reina Sofía	Córdoba, 14004, Spain
Completed	Clínica Universidad de Navarra CUN	Pamplona, 31008, Spain
Completed	Hospital Universitari i Politècnic La Fe	Valencia, 46026, Spain
Completed	Ciutat Sanitària i Universitaria de la Vall d'Hebron	Barcelona, 08035, Spain
Completed	Hospital de la Santa Creu i de Sant Pau	Barcelona, 08025, Spain
Completed	Hospital de Cruces	Barakaldo, 48903, Spain
Completed	Hospital Clínico Universitario de Santiago de Compostela	Santiago de Compostela, 15706, Spain
Completed	Hospital Clínic i Provincial de Barcelona	Barcelona, 08036, Spain
Completed	Hospital Clínico Universitario Lozano Blesa	Zaragoza, 50009, Spain
Completed	Sunnybrook Health Sciences Centre	Toronto, M4N 3M5, Canada
Completed	Ottawa Hospital-General Campus	Ottawa, K1H 8L6, Canada
Completed	Cross Cancer Institute	Edmonton, T6G 1Z2, Canada
Completed	London Health Sciences Centre	London, N6A 4G5, Canada
Completed	AZ Groeninge Campus Vercruysselaan	KORTRIJK, 8500, Belgium
Completed	Clinique Saint-Pierre	OTTIGNIES, 1340, Belgium
Completed	Medisch Centrum Alkmaar	ALKMAAR, 1815 JD, Netherlands
Completed	Canisius Wilhelmina Ziekenhuis	NIJMEGEN, 6532 SZ, Netherlands
Completed	Erasmus Medisch Centrum	ROTTERDAM, 3015 CE, Netherlands
Completed	Oslo universitetssykehus HF Radiumhospitalet	Oslo, N-0310, Norway
Completed	Helse Bergen HF Haukeland universitetssjukehus	Bergen, 5021, Norway
Completed	Oslo Universitetssykehus HF, Ullevål	Oslo, 0450, Norway
Completed	Sørlandet sykehus HF Kristiansand	Kristiansand, N-4604, Norway
Completed	Helse Møre og Romsdal HF	Ålesund, 6026, Norway
Completed	Universitetssykehuset Nord-Norge HF Tromsø	Tromsø, 9038, Norway
Completed	Nordlandssykehuset HF	Bodø, 8092, Norway
Completed	St Olavs Hospital HF	Trondheim, 7006, Norway
Completed	Nemocnice Chomutov, o.z.	Chomutov, 430 12, Czech Republic
Completed	Fakultni nemocnice Ostrava	Ostrava, 708 52, Czech Republic
Completed	Fakultni nemocnice Plzen	Plzen - Bory, 305 99, Czech Republic
Completed	Masarykuv onkologicky ustav	Brno, 65653, Czech Republic
Completed	Fakultni Nemocnice Olomouc	Olomouc, 775 20, Czech Republic
Completed	Masaryk Hospital Usti n/L	Usti nad Labem, 401 13, Czech Republic
Completed	Fakultni Thomayerova Nemocnice	Praha 4, 140 59, Czech Republic
Completed	Tel-Aviv Sourasky Medical Center	Tel Aviv, 6423906, Israel
Completed	Meir Medical Center	Kfar Saba, 4428164, Israel
Completed	Soroka University Medical Center	Beer Sheva, 8410101, Israel
Completed	Assaf Harofeh Medical Center	Zrifin, 6093000, Israel
Completed	Royal Adelaide Hospital	Adelaide, 5000, Australia
Completed	St Vincents Hospital Sydney	Sydney, 2010, Australia
Completed	Royal Brisbane and Women's Hospital	Brisbane, 4029, Australia
Completed	St Vincents Hospital	Fitzroy, 3065, Australia
Completed	Royal Hobart Hospital	Hobart, 7000, Australia
Completed	Prince of Wales Hospital	Randwick, 2031, Australia
Completed	Royal North Shore Hospital	St Leonards, 2065, Australia
Completed	Toowoomba Cancer Research Centre	Toowoomba, 4350, Australia
Completed	Wollongong Hospital	Wollongong, 2521, Australia
Completed	Queen Elizabeth Hospital	Adelaide, 5011, Australia
Completed	Liverpool Hospital	Liverpool, 2170, Australia
Completed	Sir Charles Gairdner Hospital	Nedlands, 6009, Australia
Completed	Sydney Adventist Hospital	Wahroonga, 2076, Australia
Completed	Hospital Luxemburgo	Belo Horizonte, 30380490, Brazil
Completed	Hospital das Clínicas da Faculdade de Medicina da USP	Sao Paulo, 05403-900, Brazil
Completed	Hospital Universitario Pedro Ernesto	Rio de Janeiro, 20551 030, Brazil
Completed	Hospital de Clínicas de Porto Alegre	Porto Alegre, Brazil
Completed	Santa Casa de Misericórdia de Piracicaba	Piracicaba, Brazil
Completed	Hospital Lifecenter	Belo Horizonte, 30110-090, Brazil
Completed	Assistência Multidisciplinar em Oncologia (AMO)	Salvador, 41830-492, Brazil
Completed	Fundação Pio XII – Hospital de Câncer de Barretos	Barretos, 14784400, Brazil
Completed	Faculty Hospital F. D. Roosevelt	Banska Bystrica, 97517, Slovakia
Completed	Dererova nemocnica s poliklinikou	Bratislava, 83305, Slovakia
Completed	Univerzitna nemocnica Bratislava, Nemocnica Ruzinov	Bratislava, 82606, Slovakia
Completed	URO Centrum s.r.o.	Trnava, 917 01, Slovakia
Completed	Univerzitna nemocnica Martin	Martin, 03659, Slovakia
Completed	Fakultna nemocnica s poliklinikou J.A. Reimana	Presov, 08181, Slovakia
Completed	Queen Mary Hospital	Hong Kong, Hong Kong
Completed	Queen Elizabeth Hospital	Kowloon, Hong Kong
Completed	Pamela Youde Nethersole Eastern Hospital	Chai Wan, Hong Kong
Completed	Tuen Mun Hospital	Hongkong, Hong Kong
Completed	Tan Tock Seng Hospital	Singapore, 308433, Singapore
Completed	OncoCare Cancer Centre	Singapore, 258499, Singapore
Completed	Fundación Hospital Alcorcón	Alcorcón, 28922, Spain
Completed	Länssjukhuset Sundsvall-Härnösand	Sundsvall, 851 86, Sweden
Completed	Länssjukhuset i Kalmar	Kalmar, 391 85, Sweden
Completed	Ryhov Hospital	Jönköping, 551 85, Sweden
Completed	Sahlgrenska Universitetssjukhuset	Göteborg, 413 45, Sweden
Completed	Norrlands Universitetssjukhus, Umeå	Umeå, 901 85, Sweden
Completed	Karolinska Universitetssjukhuset i Solna	Stockholm, 171 76, Sweden
Completed	Länssjukhuset Gävle-Sandviken	Sandviken, 80187, Sweden
Completed	Universitetssjukhuset MAS	Malmö, 205 02, Sweden

Primary Outcome

Overall survival
Overall survival was defined as the time from date of randomization to the date of death.
Time Frame:
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)
Safety Issue:
No

Secondary Outcome

Time to total Alkaline Phosphatase (ALP) progression
The 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 later
Time Frame:
From randomization to first ALP progression until approximately 3 years after start of enrollment
Safety Issue:
No
Percentage of Participants with Total ALP response at Week 12
ALP 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.
Time Frame:
At Baseline and Week 12
Safety Issue:
No
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.
Time Frame:
At Baseline and End of Treatment (Week 24 or at the time the patient dies or discontinues treatment phase)
Safety Issue:
No
Percentage of Participants with Total ALP normalization at Week 12
The 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.
Time Frame:
At Baseline and Week 12
Safety Issue:
No
Percentage change from baseline in total ALP at Week 12
ALP 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)*100
Time Frame:
At Baseline and Week 12
Safety Issue:
No
Maximum Percentage Decrease from baseline in total ALP up to Week 12
ALP 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.
Time Frame:
From baseline to Week 12
Safety Issue:
No
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)*100
Time Frame:
At Baseline and End of Treatment (Week 24 or at the time the patient dies or discontinues treatment phase)
Safety Issue:
No
Maximum Percentage decrease from baseline in total ALP During the 24 Week Treatment
ALP 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.
Time Frame:
From baseline During the 24 Week Treatment
Safety Issue:
No
Time to Prostate Specific Antigen (PSA) progression
The 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 later
Time Frame:
From randomization to first PSA progression until approximately 3 years after start of enrollment
Safety Issue:
No
Percentage of Participants with PSA response at Week 12
PSA 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.
Time Frame:
At Baseline and Week 12
Safety Issue:
No
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.
Time Frame:
At Baseline and End of Treatment (Week 24 or at the time the patient dies or discontinues treatment phase)
Safety Issue:
No
Percentage change from baseline in PSA at Week 12
PSA 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)*100
Time Frame:
At Baseline and Week 12
Safety Issue:
No
Maximum Percentage Decrease from baseline in PSA up to Week 12
PSA 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.
Time Frame:
From baseline up to Week 12
Safety Issue:
No
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)*100
Time Frame:
At Baseline and End of Treatment (Week 24 or at the time the patient dies or discontinues treatment phase)
Safety Issue:
No
Maximum Percentage Decrease from Baseline in PSA response During the 24 Week Treatment Period
PSA 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.
Time Frame:
From baseline to End of Treatment (Week 24; 4 weeks post last injection)
Safety Issue:
No
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.
Time Frame:
From randomization to first first SRE until approximately 3 years after start of enrollment
Safety Issue:
No
Time to occurrence of first use of External Beam Radiation Therapy (EBRT) to relieve skeletal symptoms
The 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.
Time Frame:
From randomization to first EBRT until approximately 3 years after start of enrollment
Safety Issue:
No
Time to occurrence of first use of radioisotopes to relieve skeletal symptoms
The 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.
Time Frame:
From randomization to first use of radioisotopes until approximately 3 years after start of enrollment
Safety Issue:
No
Time to occurrence of first new symptomatic pathological bone fractures, vertebral and non-vertebral
The 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.
Time Frame:
From randomization to occurrence of first new symptomatic pathological bone fractures until approximately 3 years after start of enrollment
Safety Issue:
No
Time to occurrence of first tumor related orthopedic surgical intervention
The 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.
Time Frame:
From randomization to occurrence of first tumor related orthopedic surgical intervention until approximately 3 years after start of enrollment
Safety Issue:
No
Time to occurrence of first spinal cord compression
The 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.
Time Frame:
From randomization to first spinal cord compression until approximately 3 years after start of enrollment
Safety Issue:
No
Time to occurrence of first start of any other anti-cancer treatment
The 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.
Time Frame:
From randomization to first start of any other anti-cancer treatment until approximately 3 years after start of enrollment
Safety Issue:
No
Time to occurrence of first deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) by at least 2 points from baseline
ECOG 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.
Time Frame:
From randomization to first deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) until approximately 3 years after start of enrollment
Safety Issue:
No

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

Additional Information

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