Radium(223) Dichloride (Alpharadin) in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients With Bone Metastases

March 30, 2017 updated by: Bayer

Radium-223 Dichloride (Alpharadin) in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients With Bone Metastases

This study is a prospective, interventional, open-label, multi-center early access program for the use of Ra-223 Cl2 in HRPC/CRPC (Hormone refractory prostate cancer / Castrate resistant prostate cancer) patients diagnosed with bone metastasis and to collect additional short and long term safety data on the product.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

705

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brugge, Belgium, 8000
      • Bruxelles - Brussel, Belgium, 1200
      • Bruxelles - Brussel, Belgium, 1000
      • Bruxelles - Brussel, Belgium, 1090
      • Edegem, Belgium, 2650
      • Gent, Belgium, 9000
      • Kortrijk, Belgium, 8500
      • Leuven, Belgium, 3000
      • Ottignies, Belgium, 1340
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
      • Toronto, Ontario, Canada, M5G 2M9
      • Toronto, Ontario, Canada, M4N 3M5
    • Quebec
      • Montreal, Quebec, Canada, H2L 4M1
  • Czech Republic
      • Brno, Czech Republic, 656 91
      • Ostrava, Czech Republic, 708 52
      • Plzen - Bory, Czech Republic, 305 99
      • Praha 4, Czech Republic, 140 59
      • Praha 5, Czech Republic, 150 06
  • Denmark
      • Herlev, Denmark, 2730
      • København, Denmark, 2100
      • Odense, Denmark, 5000
  • Finland
      • HUS, Finland, 00029
      • Helsinki, Finland, 00180
      • Kuopio, Finland, 70211
      • Seinäjoki, Finland, 60220
      • Tampere, Finland, FIN-33520
  • France
      • Angers Cedex 01, France, 49033
      • Avignon, France, 84000
      • Caen Cedex 5, France, 14076
      • Clermont Ferrand Cedex 1, France, 63011
      • Grenoble, France, 38043
      • La Roche Sur Yon Cedex, France, 85025
      • Lille, France, 59037
      • Lille Cedex, France, 59020
      • Montpellier, France, 34070
      • Montpellier Cedex, France, 34298
      • Paris, France, 75674
      • Paris, France, 75010
      • Paris Cedex 15, France, 75908
      • Poitiers Cedex, France, 86021
      • Saint Herblain, France, 44805
      • Suresnes, France, 92151
      • TOULOUSE cedex, France, 31059
      • Vandoeuvre les Nancy, France, 54500
      • Villejuif Cedex, France, 94805
  • Germany
      • Berlin, Germany, 12200
      • Berlin, Germany, 10719
      • Berlin, Germany, 10967
      • Berlin, Germany, 14197
      • Bremen, Germany, 28277
      • Hamburg, Germany, 20246
      • Magdeburg, Germany, 39120
    • Baden-Württemberg
      • Freiburg im Breisgrau, Baden-Württemberg, Germany, 79106
      • Heidelberg, Baden-Württemberg, Germany, 69112
      • Tübingen, Baden-Württemberg, Germany, 72076
      • Ulm, Baden-Württemberg, Germany, 89075
    • Bayern
      • Erlangen, Bayern, Germany, 91054
      • München, Bayern, Germany, 81675
      • München, Bayern, Germany, 81377
    • Hessen
      • Frankfurt, Hessen, Germany, 60590
      • Marburg, Hessen, Germany, 35043
    • Mecklenburg-Vorpommern
      • Greifswald, Mecklenburg-Vorpommern, Germany, 17475
      • Rostock, Mecklenburg-Vorpommern, Germany, 18107
      • Rostock, Mecklenburg-Vorpommern, Germany, 18057
    • Niedersachsen
      • Braunschweig, Niedersachsen, Germany, 38118
      • Göttingen, Niedersachsen, Germany, 37075
      • Hannover, Niedersachsen, Germany, 30625
      • Hannover, Niedersachsen, Germany, 30559
    • Nordrhein-Westfalen
      • Aachen, Nordrhein-Westfalen, Germany, 52074
      • Bonn, Nordrhein-Westfalen, Germany, 53105
      • Düsseldorf, Nordrhein-Westfalen, Germany, 40225
      • Münster, Nordrhein-Westfalen, Germany, 48149
      • Recklinghausen, Nordrhein-Westfalen, Germany, 45657
    • Rheinland-Pfalz
      • Mainz, Rheinland-Pfalz, Germany, 55131
    • Saarland
      • Homburg, Saarland, Germany, 66421
    • Sachsen
      • Chemnitz, Sachsen, Germany, 09119
      • Dresden, Sachsen, Germany, 01307
    • Thüringen
      • Jena, Thüringen, Germany, 07740
  • Ireland
      • Cork, Ireland
      • Dublin 6, Ireland
      • Galway, Ireland
  • Israel
      • Beer Sheva, Israel, 8410101
      • Haifa, Israel, 3109601
      • Jerusalem, Israel, 9112001
      • Kfar Saba, Israel, 4428164
      • Petah Tikva, Israel, 4941492
      • Ramat Gan, Israel, 5262000
      • Rehovot, Israel, 7610001
      • Tel Aviv, Israel, 6423906
      • Zerifin, Israel, 6093000
  • Italy
    • Campania
      • Napoli, Campania, Italy, 80131
    • Emilia-Romagna
      • Forlì, Emilia-Romagna, Italy, 47014
      • Modena, Emilia-Romagna, Italy, 41124
      • Reggio Emilia, Emilia-Romagna, Italy, 42123
    • Friuli-Venezia Giulia
      • Pordenone, Friuli-Venezia Giulia, Italy, 33081
    • Lazio
      • Roma, Lazio, Italy, 00144
      • Roma, Lazio, Italy, 00168
      • Roma, Lazio, Italy, 00161
      • Roma, Lazio, Italy, 00149
      • Roma, Lazio, Italy, 00189
    • Liguria
      • Genova, Liguria, Italy, 16128
      • Genova, Liguria, Italy, 16132
    • Lombardia
      • Bergamo, Lombardia, Italy, 24128
      • Brescia, Lombardia, Italy, 25123
      • Milano, Lombardia, Italy, 20132
      • Milano, Lombardia, Italy, 20133
      • Milano, Lombardia, Italy, 20089
      • Milano, Lombardia, Italy, 20162
    • Piemonte
      • Torino, Piemonte, Italy, 10043
      • Torino, Piemonte, Italy, 10060
    • Puglia
      • Bari, Puglia, Italy, 70124
      • Brindisi, Puglia, Italy, 72100
      • Foggia, Puglia, Italy, 71013
    • Sardegna
      • Cagliari, Sardegna, Italy, 09125
    • Sicilia
      • Messina, Sicilia, Italy, 98125
    • Toscana
      • Arezzo, Toscana, Italy, 52100
      • Firenze, Toscana, Italy, 50134
      • Pisa, Toscana, Italy, 56126
    • Trentino-Alto Adige
      • Trento, Trentino-Alto Adige, Italy, 38122
    • Veneto
      • Padova, Veneto, Italy, 35128
      • Treviso, Veneto, Italy, 31100
      • Verona, Veneto, Italy, 37126
  • Mexico
    • Distrito Federal
      • Mexico, D.F., Distrito Federal, Mexico, 01120
      • México, Distrito Federal, Mexico, 14080
  • Netherlands
      • Alkmaar, Netherlands, 1815 JD
      • Amsterdam, Netherlands, 1081 HV
      • Leiden, Netherlands, 2333 ZA
      • Nijmegen, Netherlands, 6525 GA
      • Zwolle, Netherlands, 8025 AB
  • Norway
      • Bergen, Norway, 5021
      • Bodø, Norway, 8092
      • Lørenskog, Norway, 1478
      • Oslo, Norway
      • Oslo, Norway, 0424
      • Ålesund, Norway, 6026
  • Poland
      • Bialystok, Poland, 15-027
      • Warszawa, Poland, 02-781
  • Russian Federation
      • Moscow, Russian Federation, 115478
      • Obninsk, Russian Federation, 249036
  • Spain
      • A Coruña, Spain, 15006
      • Barcelona, Spain, 08036
      • Barcelona, Spain, 08035
      • Barcelona, Spain, 08025
      • León, Spain, 24008
      • Lugo, Spain, 27004
      • Madrid, Spain, 28046
      • Madrid, Spain, 28041
      • Madrid, Spain, 28007
      • Madrid, Spain, 28033
      • Malaga, Spain, 29010
      • Málaga, Spain, 29010
      • Oviedo, Spain, 33006
      • Pamplona, Spain, 31008
      • Salamanca, Spain, 37007
      • Santander, Spain, 39008
      • Sevilla, Spain, 41013
      • Sevilla, Spain, 41071
      • Valencia, Spain, 46014
      • Valencia, Spain, 46026
      • Valencia, Spain, 46009
      • Zaragoza, Spain, 50009
    • A Coruña
      • Santiago de Compostela, A Coruña, Spain, 15706
    • Andalucía
      • Córdoba, Andalucía, Spain, 14004
    • Barcelona
      • Hospitalet de Llobregat, Barcelona, Spain, 08907
    • Bilbao
      • Cruces/Barakaldo, Bilbao, Spain, 48903
    • Canarias
      • Santa Cruz de Tenerife, Canarias, Spain, 38009
    • Illes Baleares
      • Palma de Mallorca, Illes Baleares, Spain
    • Las Palmas
      • Las Palmas de Gran Canaria, Las Palmas, Spain, 35020
  • Sweden
      • Eskilstuna, Sweden, 633 52
      • Kalmar, Sweden, 391 85
      • Karlstad, Sweden, 651 85
      • Linköping, Sweden, 581 85
      • Lund, Sweden, 221 85
      • Stockholm, Sweden, 171 76
      • Sundsvall, Sweden, 851 86
      • Umeå, Sweden, 901 85
      • Uppsala, Sweden, 751 85
      • Örebro, Sweden, 715 92
  • Switzerland
      • Bern, Switzerland, 3010
      • Zürich, Switzerland, 8091
    • Aargau
      • Aarau, Aargau, Switzerland, 5001
    • Basel-Stadt
      • Basel, Basel-Stadt, Switzerland, 4056
    • Graubünden
      • Chur, Graubünden, Switzerland, 7000
    • Sankt Gallen
      • St. Gallen, Sankt Gallen, Switzerland, 9007
    • Ticino
      • Bellinzona, Ticino, Switzerland, 6500
    • Vaud
      • Lausanne, Vaud, Switzerland, 1011
  • United Kingdom
      • Aberdeen, United Kingdom, AB25 2ZN
      • Belfast, United Kingdom, BT9 7AB
      • Bristol, United Kingdom, BS2 8ED
      • Cardiff, United Kingdom, CF14 2TL
      • Derby, United Kingdom, DE22 3NE
      • Glasgow, United Kingdom, G12 0YN
      • Hull, United Kingdom, HU16 5JQ
      • Leeds, United Kingdom, LS9 7TF
      • London, United Kingdom, SE1 9RT
      • Manchester, United Kingdom, M20 4BX
      • Newcastle Upon Tyne, United Kingdom, NE7 7DN
      • Plymouth, United Kingdom, PL6 8DH
      • Southampton, United Kingdom, SO16 6YD
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
    • Essex
      • Romford, Essex, United Kingdom, RM7 0AG
    • Leicestershire
      • Leicester, Leicestershire, United Kingdom, LE1 5WW
    • Lothian
      • Edinburgh, Lothian, United Kingdom, EH4 2XU
    • Merseyside
      • Bebington, Merseyside, United Kingdom, CH63 4JY
    • Middlesex
      • Northwood, Middlesex, United Kingdom, HA6 2VR
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
    • Somerset
      • Taunton, Somerset, United Kingdom, TA1 5DA
    • South Yorkshire
      • Sheffield, South Yorkshire, United Kingdom, S10 2SJ
    • Surrey
      • Guildford, Surrey, United Kingdom, GU2 7XX
      • Sutton, Surrey, United Kingdom, SM2 5PT
    • Warwickshire
      • Coventry, Warwickshire, United Kingdom, CV2 2DX
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B15 2TH
      • Wolverhampton, West Midlands, United Kingdom, WV10 0QP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Age ≥18 years of age
  • Histologically or cytologically confirmed prostate cancer
  • Patients diagnosed with progressive bone predominant metastatic CRPC/HRPC (Hormone refractory prostate cancer / Castrate resistant prostate cancer) with at least 2 skeletal metastases on imaging with no lung, liver, and/or brain metastasis (lymph node only metastasis is allowed)

  • Progressive disease is defined either by:

    • The appearance of new bone lesions. If progression is based on new lesion(s) on imaging only without an increase in prostate specific antigen (PSA), PSA values from 3 assessments within the last 6 months must be provided; OR
    • In the absence of new bone lesions by 2 subsequent increases in serum PSA over previous reference value, which should not be more than 6 months before screening, each measured at least 1 week apart with the last PSA ≥ 5 ng/mL. (The reference value time point 1, is defined as the last PSA measured before increases are documented, with subsequent values obtained a minimum of 1 week apart. If the PSA at time point 3 is greater than the PSA at time point 2, then eligibility has been met. If the PSA at time point 3 is not greater than the PSA at time point 2 but the PSA value at time point 4 and/or time point 5 is greater than the PSA at time point 2, the patient is eligible assuming that other criteria are met)
  • Life expectancy ≥ 6 months
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 - 2

  • Adequate hematological, liver, and renal function

    • Absolute neutrophil count (ANC) ≥ 1.5 x10^9/L
    • Platelet count ≥ 100 x10^9/L
    • Hemoglobin ≥ 10.0 g/dL (100 g/L; 6.2 mmol/L)
    • Total bilirubin level ≤ 1.5 x institutional upper limit of normal (ULN)
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN
    • Creatinine ≤ 1.5 x ULN
    • Albumin > 25 g/L

Exclusion Criteria:

  • Treatment with an investigational drug within previous 4 weeks, or planned during the treatment period or follow-up
  • Eligible for first course of docetaxel, i.e., patients who are fit enough, willing, and who are located where treatment with docetaxel is available
  • Treatment with cytotoxic chemotherapy within previous 4 weeks, or failure to recover from AEs (adverse events) due to cytotoxic chemotherapy administered more than 4 weeks previous (however, ongoing neuropathy is permitted)
  • Prior hemibody external radiotherapy is excluded. Patients who received other types of prior external radiotherapy are allowed provided that the bone marrow function is assessed and meets the protocol requirements for hemoglobin, absolute neutrophil count and platelets
  • Received systemic therapy with radionuclides (e.g., strontium-89, samarium-153, rhenium-186, or rhenium-188, or radium-223 dichloride) for the treatment of bony metastases
  • Other malignancy treated within the last 3 years (except non melanoma skin cancer or low-grade superficial bladder cancer)
  • Visceral metastases as assessed by abdominal or pelvic computed tomography (CT) (or other imaging modality based on institutional standard of care)
  • Presence of brain metastases
  • Lymphadenopathy exceeding 6 cm in short-axis diameter
  • Any size pelvic lymphadenopathy if it is thought to be a contributor to concurrent hydronephrosis
  • Imminent or history of spinal cord compression based on clinical findings and/or magnetic resonance imaging (MRI). Patients with history of spinal cord compression should have completely recovered.

  • Any other serious illness or medical condition, such as but not limited to:

    • Any infection ≥ National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 Grade 2
    • Cardiac failure New York Heart Association (NYHA) III or IV
    • Crohn's disease or ulcerative colitis
    • Bone marrow dysplasia
  • Fecal incontinence

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Radium-223 dichloride
Drug: Radium-223 dichloride (BAY88-8223)
One injection to be administered every 4 weeks up to 6 injections. The dose per injection is 50 kBq/kg body weight.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acute safety, variables will be summarized using descriptive statistics based on adverse events collection
Time Frame: From baseline to 30 days post-treatment
Safety variables to be analyzed during the treatment period include: ECOG PS, Skeletal-related events, Treatment emergent Grade 3-4 AEs, any grade of treatment-related AEs and SAEs, Safety laboratory tests including hematology and serum chemistry
From baseline to 30 days post-treatment
Long-term safety, variables will be summarized using descriptive statistics based on adverse events collection
Time Frame: From 30 days post-treatment up to 3 years
Safety variables to be analyzed during the follow-up period include: Skeletal-related events, Treatment related AEs and SAEs, Secondary malignancies
From 30 days post-treatment up to 3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Brief Pain Inventory, as assessed by BPI-SF questionnaire (Brief Pain Inventory-Short Form)
Time Frame: From baseline up to 1 year
From baseline up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 22, 2012

Primary Completion (Actual)

August 13, 2014

Study Completion (Actual)

February 28, 2016

Study Registration Dates

First Submitted

June 11, 2012

First Submitted That Met QC Criteria

June 11, 2012

First Posted (Estimate)

June 13, 2012

Study Record Updates

Last Update Posted (Actual)

March 31, 2017

Last Update Submitted That Met QC Criteria

March 30, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16216
  • 2012-000075-16 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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