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

Sponsor
Bayer (Industry)
Overall Status
Completed
CT.gov ID
NCT01618370
Collaborator
(none)
705
Enrollment
215
Locations
1
Arm
43.2
Actual Duration (Months)
3.3
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Radium-223 dichloride (BAY88-8223)
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
705 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Radium-223 Dichloride (Alpharadin) in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients With Bone Metastases
Actual Study Start Date :
Jul 22, 2012
Actual Primary Completion Date :
Aug 13, 2014
Actual Study Completion Date :
Feb 28, 2016

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

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

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

Secondary Outcome Measures

  1. Brief Pain Inventory, as assessed by BPI-SF questionnaire (Brief Pain Inventory-Short Form) [From baseline up to 1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Brugge Belgium 8000
2 Bruxelles - Brussel Belgium 1000
3 Bruxelles - Brussel Belgium 1090
4 Bruxelles - Brussel Belgium 1200
5 Edegem Belgium 2650
6 Gent Belgium 9000
7 Kortrijk Belgium 8500
8 Leuven Belgium 3000
9 Ottignies Belgium 1340
10 Edmonton Alberta Canada T6G 1Z2
11 Vancouver British Columbia Canada V5Z 4E6
12 Ottawa Ontario Canada K1H 8L6
13 Toronto Ontario Canada M4N 3M5
14 Toronto Ontario Canada M5G 2M9
15 Montreal Quebec Canada H2L 4M1
16 Brno Czech Republic 656 91
17 Ostrava Czech Republic 708 52
18 Plzen - Bory Czech Republic 305 99
19 Praha 4 Czech Republic 140 59
20 Praha 5 Czech Republic 150 06
21 Herlev Denmark 2730
22 København Denmark 2100
23 Odense Denmark 5000
24 Helsinki Finland 00180
25 HUS Finland 00029
26 Kuopio Finland 70211
27 Seinäjoki Finland 60220
28 Tampere Finland FIN-33520
29 Angers Cedex 01 France 49033
30 Avignon France 84000
31 Caen Cedex 5 France 14076
32 Clermont Ferrand Cedex 1 France 63011
33 Grenoble France 38043
34 La Roche Sur Yon Cedex France 85025
35 Lille Cedex France 59020
36 Lille France 59037
37 Montpellier Cedex France 34298
38 Montpellier France 34070
39 Paris Cedex 15 France 75908
40 Paris France 75010
41 Paris France 75674
42 Poitiers Cedex France 86021
43 Saint Herblain France 44805
44 Suresnes France 92151
45 TOULOUSE cedex France 31059
46 Vandoeuvre les Nancy France 54500
47 Villejuif Cedex France 94805
48 Freiburg im Breisgrau Baden-Württemberg Germany 79106
49 Heidelberg Baden-Württemberg Germany 69112
50 Tübingen Baden-Württemberg Germany 72076
51 Ulm Baden-Württemberg Germany 89075
52 Erlangen Bayern Germany 91054
53 München Bayern Germany 81377
54 München Bayern Germany 81675
55 Frankfurt Hessen Germany 60590
56 Marburg Hessen Germany 35043
57 Greifswald Mecklenburg-Vorpommern Germany 17475
58 Rostock Mecklenburg-Vorpommern Germany 18057
59 Rostock Mecklenburg-Vorpommern Germany 18107
60 Braunschweig Niedersachsen Germany 38118
61 Göttingen Niedersachsen Germany 37075
62 Hannover Niedersachsen Germany 30559
63 Hannover Niedersachsen Germany 30625
64 Aachen Nordrhein-Westfalen Germany 52074
65 Bonn Nordrhein-Westfalen Germany 53105
66 Düsseldorf Nordrhein-Westfalen Germany 40225
67 Münster Nordrhein-Westfalen Germany 48149
68 Recklinghausen Nordrhein-Westfalen Germany 45657
69 Mainz Rheinland-Pfalz Germany 55131
70 Homburg Saarland Germany 66421
71 Chemnitz Sachsen Germany 09119
72 Dresden Sachsen Germany 01307
73 Jena Thüringen Germany 07740
74 Berlin Germany 10719
75 Berlin Germany 10967
76 Berlin Germany 12200
77 Berlin Germany 14197
78 Bremen Germany 28277
79 Hamburg Germany 20246
80 Magdeburg Germany 39120
81 Cork Ireland
82 Dublin 6 Ireland
83 Galway Ireland
84 Beer Sheva Israel 8410101
85 Haifa Israel 3109601
86 Jerusalem Israel 9112001
87 Kfar Saba Israel 4428164
88 Petah Tikva Israel 4941492
89 Ramat Gan Israel 5262000
90 Rehovot Israel 7610001
91 Tel Aviv Israel 6423906
92 Zerifin Israel 6093000
93 Napoli Campania Italy 80131
94 Forlì Emilia-Romagna Italy 47014
95 Modena Emilia-Romagna Italy 41124
96 Reggio Emilia Emilia-Romagna Italy 42123
97 Pordenone Friuli-Venezia Giulia Italy 33081
98 Roma Lazio Italy 00144
99 Roma Lazio Italy 00149
100 Roma Lazio Italy 00161
101 Roma Lazio Italy 00168
102 Roma Lazio Italy 00189
103 Genova Liguria Italy 16128
104 Genova Liguria Italy 16132
105 Bergamo Lombardia Italy 24128
106 Brescia Lombardia Italy 25123
107 Milano Lombardia Italy 20089
108 Milano Lombardia Italy 20132
109 Milano Lombardia Italy 20133
110 Milano Lombardia Italy 20162
111 Torino Piemonte Italy 10043
112 Torino Piemonte Italy 10060
113 Bari Puglia Italy 70124
114 Brindisi Puglia Italy 72100
115 Foggia Puglia Italy 71013
116 Cagliari Sardegna Italy 09125
117 Messina Sicilia Italy 98125
118 Arezzo Toscana Italy 52100
119 Firenze Toscana Italy 50134
120 Pisa Toscana Italy 56126
121 Trento Trentino-Alto Adige Italy 38122
122 Padova Veneto Italy 35128
123 Treviso Veneto Italy 31100
124 Verona Veneto Italy 37126
125 Mexico, D.F. Distrito Federal Mexico 01120
126 México Distrito Federal Mexico 14080
127 Alkmaar Netherlands 1815 JD
128 Amsterdam Netherlands 1081 HV
129 Leiden Netherlands 2333 ZA
130 Nijmegen Netherlands 6525 GA
131 Zwolle Netherlands 8025 AB
132 Bergen Norway 5021
133 Bodø Norway 8092
134 Lørenskog Norway 1478
135 Oslo Norway 0424
136 Oslo Norway
137 Ålesund Norway 6026
138 Bialystok Poland 15-027
139 Warszawa Poland 02-781
140 Moscow Russian Federation 115478
141 Obninsk Russian Federation 249036
142 Santiago de Compostela A Coruña Spain 15706
143 Córdoba Andalucía Spain 14004
144 Hospitalet de Llobregat Barcelona Spain 08907
145 Cruces/Barakaldo Bilbao Spain 48903
146 Santa Cruz de Tenerife Canarias Spain 38009
147 Palma de Mallorca Illes Baleares Spain
148 Las Palmas de Gran Canaria Las Palmas Spain 35020
149 A Coruña Spain 15006
150 Barcelona Spain 08025
151 Barcelona Spain 08035
152 Barcelona Spain 08036
153 León Spain 24008
154 Lugo Spain 27004
155 Madrid Spain 28007
156 Madrid Spain 28033
157 Madrid Spain 28041
158 Madrid Spain 28046
159 Malaga Spain 29010
160 Málaga Spain 29010
161 Oviedo Spain 33006
162 Pamplona Spain 31008
163 Salamanca Spain 37007
164 Santander Spain 39008
165 Sevilla Spain 41013
166 Sevilla Spain 41071
167 Valencia Spain 46009
168 Valencia Spain 46014
169 Valencia Spain 46026
170 Zaragoza Spain 50009
171 Eskilstuna Sweden 633 52
172 Kalmar Sweden 391 85
173 Karlstad Sweden 651 85
174 Linköping Sweden 581 85
175 Lund Sweden 221 85
176 Stockholm Sweden 171 76
177 Sundsvall Sweden 851 86
178 Umeå Sweden 901 85
179 Uppsala Sweden 751 85
180 Örebro Sweden 715 92
181 Aarau Aargau Switzerland 5001
182 Basel Basel-Stadt Switzerland 4056
183 Chur Graubünden Switzerland 7000
184 St. Gallen Sankt Gallen Switzerland 9007
185 Bellinzona Ticino Switzerland 6500
186 Lausanne Vaud Switzerland 1011
187 Bern Switzerland 3010
188 Zürich Switzerland 8091
189 Cambridge Cambridgeshire United Kingdom CB2 0QQ
190 Romford Essex United Kingdom RM7 0AG
191 Leicester Leicestershire United Kingdom LE1 5WW
192 Edinburgh Lothian United Kingdom EH4 2XU
193 Bebington Merseyside United Kingdom CH63 4JY
194 Northwood Middlesex United Kingdom HA6 2VR
195 Nottingham Nottinghamshire United Kingdom NG5 1PB
196 Taunton Somerset United Kingdom TA1 5DA
197 Sheffield South Yorkshire United Kingdom S10 2SJ
198 Guildford Surrey United Kingdom GU2 7XX
199 Sutton Surrey United Kingdom SM2 5PT
200 Coventry Warwickshire United Kingdom CV2 2DX
201 Birmingham West Midlands United Kingdom B15 2TH
202 Wolverhampton West Midlands United Kingdom WV10 0QP
203 Aberdeen United Kingdom AB25 2ZN
204 Belfast United Kingdom BT9 7AB
205 Bristol United Kingdom BS2 8ED
206 Cardiff United Kingdom CF14 2TL
207 Derby United Kingdom DE22 3NE
208 Glasgow United Kingdom G12 0YN
209 Hull United Kingdom HU16 5JQ
210 Leeds United Kingdom LS9 7TF
211 London United Kingdom SE1 9RT
212 Manchester United Kingdom M20 4BX
213 Newcastle Upon Tyne United Kingdom NE7 7DN
214 Plymouth United Kingdom PL6 8DH
215 Southampton United Kingdom SO16 6YD

Sponsors and Collaborators

  • Bayer

Investigators

  • Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bayer
ClinicalTrials.gov Identifier:
NCT01618370
Other Study ID Numbers:
  • 16216
  • 2012-000075-16
First Posted:
Jun 13, 2012
Last Update Posted:
Mar 31, 2017
Last Verified:
Mar 1, 2017
Keywords provided by Bayer
Radium 223
Alpharadin
Prostate Cancer
Bone metastases
Castrate resistant prostate cancer
Hormone refractory prostate cancer
Additional relevant MeSH terms:
Prostatic Neoplasms
Neoplasm Metastasis
Radium Ra 223 dichloride

Study Results

No Results Posted as of Mar 31, 2017