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AzTrials

Prostatic NeoplasmsPhase 3NCT01618370

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

A Phase 3 study testing Radium-223 dichloride (BAY88-8223) in people with Prostatic Neoplasms, run by Bayer at 215 sites in 19 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostatic Neoplasms
What is being tested?
Radium-223 dichloride (BAY88-8223)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
705 participants
Where
215 sitesin 19 countries
Study dates
22 Jul 2012to 28 Feb 2016
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 16Show fewer
  • 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

Who cannot join

  • 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)
Show all 17Show fewer
  • 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

Trial locations and contacts

215 sites in 19 countries.

215 sites in 19 countries

Germany33 sites

  • Study site

    Aachen, North Rhine-Westphalia, 52074

  • Study site

    Berlin, State of Berlin, 10719

  • Study site

    Berlin, State of Berlin, 10967

  • Study site

    Berlin, State of Berlin, 12200

  • Study site

    Berlin, State of Berlin, 14197

  • Study site

    Bonn, North Rhine-Westphalia, 53105

  • Study site

    Braunschweig, Lower Saxony, 38118

  • Study site

    Bremen, Free Hanseatic City of Bremen, 28277

  • Study site

    Chemnitz, Saxony, 09119

  • Study site

    Dresden, Saxony, 01307

  • Study site

    Düsseldorf, North Rhine-Westphalia, 40225

  • Study site

    Erlangen, Bavaria, 91054

  • Study site

    Frankfurt am Main, Hesse, 60590

  • Study site

    Freiburg Im Breisgrau, Baden-Wurttemberg, 79106

  • Study site

    Göttingen, Lower Saxony, 37075

  • Study site

    Greifswald, Mecklenburg-Vorpommern, 17475

  • Study site

    Hamburg, Free and Hanseatic City of Hamburg, 20246

  • Study site

    Hanover, Lower Saxony, 30559

  • Study site

    Hanover, Lower Saxony, 30625

  • Study site

    Heidelberg, Baden-Wurttemberg, 69112

  • Study site

    Homburg, Saarland, 66421

  • Study site

    Jena, Thuringia, 07740

  • Study site

    Magdeburg, 39120

  • Study site

    Mainz, Rhineland-Palatinate, 55131

  • Study site

    Marburg, Hesse, 35043

  • Study site

    München, Bavaria, 81377

  • Study site

    München, Bavaria, 81675

  • Study site

    Münster, North Rhine-Westphalia, 48149

  • Study site

    Recklinghausen, North Rhine-Westphalia, 45657

  • Study site

    Rostock, Mecklenburg-Vorpommern, 18057

  • Study site

    Rostock, Mecklenburg-Vorpommern, 18107

  • Study site

    Tübingen, Baden-Wurttemberg, 72076

  • Study site

    Ulm, Baden-Wurttemberg, 89075

Other trials in Germany

Italy32 sites

  • Study site

    Arezzo, Tuscany, 52100

  • Study site

    Bari, Apulia, 70124

  • Study site

    Bergamo, Lombardy, 24128

  • Study site

    Brescia, Lombardy, 25123

  • Study site

    Brindisi, Apulia, 72100

  • Study site

    Cagliari, Sardinia, 09125

  • Study site

    Florence, Tuscany, 50134

  • Study site

    Foggia, Apulia, 71013

  • Study site

    Forlì, Emilia-Romagna, 47014

  • Study site

    Genoa, Liguria, 16128

  • Study site

    Genoa, Liguria, 16132

  • Study site

    Messina, Sicily, 98125

  • Study site

    Milan, Lombardy, 20089

  • Study site

    Milan, Lombardy, 20132

  • Study site

    Milan, Lombardy, 20133

  • Study site

    Milan, Lombardy, 20162

  • Study site

    Modena, Emilia-Romagna, 41124

  • Study site

    Naples, Campania, 80131

  • Study site

    Padova, Veneto, 35128

  • Study site

    Pisa, Tuscany, 56126

  • Study site

    Pordenone, Friuli Venezia Giulia, 33081

  • Study site

    Reggio Emilia, Emilia-Romagna, 42123

  • Study site

    Rome, Lazio, 00144

  • Study site

    Rome, Lazio, 00149

  • Study site

    Rome, Lazio, 00161

  • Study site

    Rome, Lazio, 00168

  • Study site

    Rome, Lazio, 00189

  • Study site

    Trento, Trentino-Alto Adige, 38122

  • Study site

    Treviso, Veneto, 31100

  • Study site

    Turin, Piedmont, 10043

  • Study site

    Turin, Piedmont, 10060

  • Study site

    Verona, Veneto, 37126

Other trials in Italy

Spain29 sites

  • Study site

    A Coruña, A Coruña, 15006

  • Study site

    Barcelona, Barcelona, 08025

  • Study site

    Barcelona, Barcelona, 08035

  • Study site

    Barcelona, Barcelona, 08036

  • Study site

    Córdoba, Andalusia, 14004

  • Study site

    Cruces/Barakaldo, Bilbao, 48903

  • Study site

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Study site

    Las Palmas de Gran Canaria, Las Palmas, 35020

  • Study site

    León, León, 24008

  • Study site

    Lugo, Lugo, 27004

  • Study site

    Madrid, Madrid, 28041

  • Study site

    Madrid, Madrid, 28046

  • Study site

    Madrid, 28007

  • Study site

    Madrid, 28033

  • Study site

    Málaga, Málaga, 29010

  • Study site

    Málaga, 29010

  • Study site

    Oviedo, Oviedo, 33006

  • Study site

    Palma de Mallorca, Illes Baleares

  • Study site

    Pamplona, Pamplona, 31008

  • Study site

    Salamanca, Salamanca, 37007

  • Study site

    Santa Cruz de Tenerife, Canary Islands, 38009

  • Study site

    Santander, Cantabria, 39008

  • Study site

    Santiago de Compostela, A Coruña, 15706

  • Study site

    Seville, Sevilla, 41013

  • Study site

    Seville, Sevilla, 41071

  • Study site

    Valencia, Valencia, 46009

  • Study site

    Valencia, Valencia, 46014

  • Study site

    Valencia, Valencia, 46026

  • Study site

    Zaragoza, 50009

Other trials in Spain

United Kingdom27 sites

  • Study site

    Aberdeen, AB25 2ZN

  • Study site

    Bebington, Merseyside, CH63 4JY

  • Study site

    Belfast, BT9 7AB

  • Study site

    Birmingham, West Midlands, B15 2TH

  • Study site

    Bristol, Bristol, BS2 8ED

  • Study site

    Cambridge, Cambridgeshire, CB2 0QQ

  • Study site

    Cardiff, CF14 2TL

  • Study site

    Coventry, Warwickshire, CV2 2DX

  • Study site

    Derby, DE22 3NE

  • Study site

    Edinburgh, Lothian, EH4 2XU

  • Study site

    Glasgow, G12 0YN

  • Study site

    Guildford, Surrey, GU2 7XX

  • Study site

    Hull, HU16 5JQ

  • Study site

    Leeds, LS9 7TF

  • Study site

    Leicester, Leicestershire, LE1 5WW

  • Study site

    London, SE1 9RT

  • Study site

    Manchester, Manchester, M20 4BX

  • Study site

    Newcastle upon Tyne, NE7 7DN

  • Study site

    Northwood, Middlesex, HA6 2VR

  • Study site

    Nottingham, Nottinghamshire, NG5 1PB

  • Study site

    Plymouth, PL6 8DH

  • Study site

    Romford, Essex, RM7 0AG

  • Study site

    Sheffield, South Yorkshire, S10 2SJ

  • Study site

    Southampton, SO16 6YD

  • Study site

    Sutton, Surrey, SM2 5PT

  • Study site

    Taunton, Somerset, TA1 5DA

  • Study site

    Wolverhampton, West Midlands, WV10 0QP

Other trials in United Kingdom

France19 sites

  • Study site

    Angers, 49033

  • Study site

    Avignon, 84000

  • Study site

    Caen, 14076

  • Study site

    Clermont-Ferrand, 63011

  • Study site

    Grenoble, 38043

  • Study site

    La Roche-sur-Yon, 85025

  • Study site

    Lille, 59020

  • Study site

    Lille, 59037

  • Study site

    Montpellier, 34070

  • Study site

    Montpellier, 34298

  • Study site

    Paris, 75010

  • Study site

    Paris, 75674

  • Study site

    Paris, 75908

  • Study site

    Poitiers, 86021

  • Study site

    Saint-Herblain, 44805

  • Study site

    Suresnes, 92151

  • Study site

    Toulouse, 31059

  • Study site

    Vandœuvre-lès-Nancy, 54500

  • Study site

    Villejuif, 94805

Other trials in France

Sweden10 sites

  • Study site

    Eskilstuna, 633 52

  • Study site

    Kalmar, 391 85

  • Study site

    Karlstad, 651 85

  • Study site

    Linköping, 581 85

  • Study site

    Lund, 221 85

  • Study site

    Örebro, 715 92

  • Study site

    Stockholm, 171 76

  • Study site

    Sundsvall, 851 86

  • Study site

    Umeå, 901 85

  • Study site

    Uppsala, 751 85

Other trials in Sweden

Belgium9 sites

  • Study site

    Bruges, 8000

  • Study site

    Bruxelles - Brussel, 1000

  • Study site

    Bruxelles - Brussel, 1090

  • Study site

    Bruxelles - Brussel, 1200

  • Study site

    Edegem, 2650

  • Study site

    Ghent, 9000

  • Study site

    Kortrijk, 8500

  • Study site

    Leuven, 3000

  • Study site

    Ottignies, 1340

Other trials in Belgium

Israel9 sites

  • Study site

    Beersheba, 8410101

  • Study site

    Haifa, 3109601

  • Study site

    Jerusalem, 9112001

  • Study site

    Kfar Saba, 4428164

  • Study site

    Petah Tikva, 4941492

  • Study site

    Ramat Gan, 5262000

  • Study site

    Rehovot, 7610001

  • Study site

    Tel Aviv, 6423906

  • Study site

    Tsrifin, 6093000

Other trials in Israel

Switzerland8 sites

  • Study site

    Aarau, Canton of Aargau, 5001

  • Study site

    Basel, Canton of Basel-City, 4056

  • Study site

    Bellinzona, Canton Ticino, 6500

  • Study site

    Bern, Canton of Bern, 3010

  • Study site

    Chur, Kanton Graubünden, 7000

  • Study site

    Lausanne, Canton of Vaud, 1011

  • Study site

    Sankt Gallen, Canton of St. Gallen, 9007

  • Study site

    Zurich, Canton of Zurich, 8091

Other trials in Switzerland

Canada6 sites

  • Study site

    Edmonton, Alberta, T6G 1Z2

  • Study site

    Montreal, Quebec, H2L 4M1

  • Study site

    Ottawa, Ontario, K1H 8L6

  • Study site

    Toronto, Ontario, M4N 3M5

  • Study site

    Toronto, Ontario, M5G 2M9

  • Study site

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Norway6 sites

  • Study site

    Ålesund, 6026

  • Study site

    Bergen, 5021

  • Study site

    Bodø, 8092

  • Study site

    Lørenskog, 1478

  • Study site

    Oslo, 0424

  • Study site

    Oslo

Other trials in Norway

Czechia5 sites

  • Study site

    Brno, 656 91

  • Study site

    Ostrava, 708 52

  • Study site

    Plzen - Bory, 305 99

  • Study site

    Prague, 140 59

  • Study site

    Prague, 150 06

Other trials in Czechia

Finland5 sites

  • Study site

    Helsinki, 00180

  • Study site

    HUS, 00029

  • Study site

    Kuopio, 70211

  • Study site

    Seinäjoki, 60220

  • Study site

    Tampere, FIN-33520

Other trials in Finland

Netherlands5 sites

  • Study site

    Alkmaar, 1815 JD

  • Study site

    Amsterdam, 1081 HV

  • Study site

    Leiden, 2333 ZA

  • Study site

    Nijmegen, 6525 GA

  • Study site

    Zwolle, 8025 AB

Other trials in Netherlands

Denmark3 sites

  • Study site

    Copenhagen, 2100

  • Study site

    Herlev, 2730

  • Study site

    Odense, 5000

Other trials in Denmark

Ireland3 sites

  • Study site

    Cork

  • Study site

    Dublin

  • Study site

    Galway, Galway

Other trials in Ireland

Mexico2 sites

  • Study site

    Mexico City, Mexico City, 01120

  • Study site

    Mexico City, Mexico City, 14080

Other trials in Mexico

Poland2 sites

  • Study site

    Bialystok, 15-027

  • Study site

    Warsaw, 02-781

Other trials in Poland

Russia2 sites

  • Study site

    Moscow, 115478

  • Study site

    Obninsk, 249036

Other trials in Russia

About this study

Official title: 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.

Being tested
Radium-223 dichloride (BAY88-8223)
Keywords
Radium 223, Alpharadin, Prostate Cancer, Bone metastases, Castrate resistant prostate cancer, Hormone refractory prostate cancer
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Radium-223 dichloride (BAY88-8223)Drug

    One injection to be administered every 4 weeks up to 6 injections. The dose per injection is 50 kBq/kg body weight.

Study groups in NCT01618370
Study groupRoleWhat they receive
Radium-223 dichlorideExperimentalNot described
Receives: Drug: Radium-223 dichloride (BAY88-8223)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Acute safety, variables will be summarized using descriptive statistics based on adverse events collection

    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

    Measured: From baseline to 30 days post-treatment

  2. Long-term safety, variables will be summarized using descriptive statistics based on adverse events collection

    Safety variables to be analyzed during the follow-up period include: Skeletal-related events, Treatment related AEs and SAEs, Secondary malignancies

    Measured: From 30 days post-treatment up to 3 years

Secondary outcomes (1)

  1. Brief Pain Inventory, as assessed by BPI-SF questionnaire (Brief Pain Inventory-Short Form)

    Measured: From baseline up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2012 (estimated)
  2. Study start22 Jul 2012
  3. Primary completion13 Aug 2014
  4. Study completion28 Feb 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
705 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01618370
Sponsor's protocol ID
16216
Other IDs
2012-000075-16
Status last verified
Mar 2017
First submitted
11 Jun 2012
Last updated
31 Mar 2017
Results posted
No
Data monitoring committee
No

Publications

  • Saad F, Gillessen S, Heinrich D, Keizman D, O'Sullivan JM, Nilsson S, Miller K, Wirth M, Reeves J, Seger M, Carles J, Heidenreich A. Disease Characteristics and Completion of Treatment in Patients With Metastatic Castration-Resistant Prostate Cancer Treated With Radium-223 in an International Early Access Program. Clin Genitourin Cancer. 2019 Oct;17(5):348-355.e5. doi: 10.1016/j.clgc.2019.05.012. Epub 2019 May 31.

    PubMed 31311763

  • Heidenreich A, Gillessen S, Heinrich D, Keizman D, O'Sullivan JM, Carles J, Wirth M, Miller K, Reeves J, Seger M, Nilsson S, Saad F. Radium-223 in asymptomatic patients with castration-resistant prostate cancer and bone metastases treated in an international early access program. BMC Cancer. 2019 Jan 7;19(1):12. doi: 10.1186/s12885-018-5203-y.

    PubMed 30612558

  • Saad F, Carles J, Gillessen S, Heidenreich A, Heinrich D, Gratt J, Levy J, Miller K, Nilsson S, Petrenciuc O, Tucci M, Wirth M, Federhofer J, O'Sullivan JM; Radium-223 International Early Access Program Investigators. Radium-223 and concomitant therapies in patients with metastatic castration-resistant prostate cancer: an international, early access, open-label, single-arm phase 3b trial. Lancet Oncol. 2016 Sep;17(9):1306-16. doi: 10.1016/S1470-2045(16)30173-5. Epub 2016 Jul 26.

    PubMed 27473888

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Radium-223 dichloride (BAY88-8223) in people with Prostatic Neoplasms, run by Bayer at 215 sites in 19 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 215 sites in Germany, Italy, Spain, United Kingdom, France and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acute safety, variables will be summarized using descriptive statistics based on adverse events collection (time frame: From baseline to 30 days post-treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01618370, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2017.

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