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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
705

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 22, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 13, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 11, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 13, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 31, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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