Trial Condition(s):

Prostatic Neoplasms

Standard dose versus high dose and versus extended standard dose radium-223 dichloride in castration-resistant prostate cancer metastatic to the bone

Bayer Identifier:

16507

ClinicalTrials.gov Identifier:

NCT02023697

EudraCT Number:

2013-003118-42

Study Completed

Trial Purpose

This study will assess different doses and regimens of radium-223 dichloride on the incidence of symptomatic skeletal events. Eligible subjects must have castration resistant prostate cancer with 2 or more skeletal metastases documented within 8 weeks of randomization. Subjects will be randomized to one of 3 treatment arms in a 1:1:1 fashion: a standard regimen of radium-223 dichloride of 50 kBq/kg (55 kBq/kg after implementation of NIST update) injections every month for 6 months, a high dose regimen of 80 kBq/kg (88 kBq/kg after implementation of NIST update)injections every month for 6 months or an extended duration regimen of 50 kBq/kg (55 kBq/kg after implementation of NIST update) injections every month for 12 months. Following the treatment phase, subjects will be followed up every 12 weeks for a minimum of 2 years, at which point they will enter a long term follow-up period during which they are seen every 6 months for up to 7 years after the last dose of radium dichloride. Symptomatic skeletal event and safety endpoints will be assessed at each clinic visit. Pain and analgesic use data will be collected every 4 weeks through Week 48. Additionally, radiological assessments including MRI/CT of the abdomen and pelvis and chest CT, as well as technetium-99 bone scans will be performed at Weeks 8, 16, and 24 and continue every 12 weeks thereafter until disease progression is documented in either the bone or in soft tissue. Radiological imaging will be evaluated by blinded central review.

Inclusion Criteria
- Histologically or cytologically confirmed adenocarcinoma of the prostate
 - Castration-resistant disease defined as:
 -- Serum testosterone level: ≤ 50 ng/dL (1.7 nmol/L)
 -- Bilateral orchiectomy or maintenance on androgen ablation therapy with luteinizing-hormone-releasing hormone (LHRH) agonist or antagonist, or polyestradiol phosphate
 -- Serum PSA (Prostate specific antigen) progression defined as 2 subsequent increases in PSA over a previous reference value (a minimum of 2 ng/mL [μg/L])   OR
 -- Radiographic evidence of disease progression in bone (according to Prostate Cancer Clinical Trials Working Group 2 [PCWG2] criteria) with or without PSA progression
 - Eastern Cooperative Oncology Group performance status (ECOG PS) 0 to 2. In case of ECOG PS 2, the PS has to be due to metastatic prostate cancer to the bone.
 - Two or more skeletal metastases (≥ 2 hot spots) on bone scintigraphy within 8 weeks of randomization
Exclusion Criteria
- History of visceral metastasis, or visceral metastases 
 - Lymphadenopathy with lymph nodes exceeding 3 cm in short axis diameter
 - Central nervous system (CNS) metastases
 - Treatment with cytotoxic chemotherapy for prostate cancer within the previous 4 weeks prior to randomization, or planned treatment with cytotoxic chemotherapy agents for prostate cancer during the treatment period or follow-up
 - Chronic conditions associated with non-malignant abnormal bone growth (e.g. confirmed Paget's disease of bone)
 - Prior treatment with radium-223 dichloride
 - Prior systemic radiotherapy and hemibody external radiotherapy

Trial Summary

Enrollment Goal
391
Trial Dates
black-arrow
Phase
2
Could I receive a placebo?
No
Products
Xofigo (Radium-223 dichloride, BAY88-8223)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
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Locations

Investigative Site

München, Germany, 81675

Status
Completed
 
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Investigative Site

Tübingen, Germany, 72076

Status
Completed
 
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Dresden, Germany, 01307

Status
Completed
 
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Scottsdale, United States, 85260

Status
Completed
 
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Rockville, United States, 20850

Status
Completed
 
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Bethesda, United States, 20889

Status
Completed
 
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St. Louis, United States, 63110

Status
Completed
 
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Detroit, United States, 48201

Status
Completed
 
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Pittsburgh, United States, 15215

Status
Completed
 
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Roma, Italy, 00152

Status
Completed
 
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Göteborg, Sweden, 413 45

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Completed
 
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Sundsvalls, Sweden, 851 86

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Completed
 
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Umeå, Sweden, 901 85

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Completed
 
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Beer Sheva, Israel, 8410101

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Completed
 
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Petah Tikva, Israel, 4941492

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Completed
 
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Jerusalem, Israel, 9112001

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Completed
 
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Haifa, Israel, 3109601

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Completed
 
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Kfar Saba, Israel, 4428164

Status
Completed
 
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Ramat Gan, Israel, 5262000

Status
Completed
 
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Adelaide, Australia, 5000

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Completed
 
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Melbourne, Australia, 3052

Status
Completed
 
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Darlinghurst, Australia, 2010

Status
Completed
 
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BOX HILL, Australia, 3128

Status
Completed
 
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Irmandade Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Brazil, 90470 340

Status
Terminated
 
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Hospital Israelita Albert Einstein

São Paulo, Brazil, 05651-901

Status
Terminated
 
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Hospital de Clínicas de Porto Alegre

Porto Alegre, Brazil

Status
Terminated
 
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Instituto do Câncer do Estado de São Paulo

São Paulo, Brazil, 01246-000

Status
Terminated
 
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Bebington, United Kingdom, CH63 4JY

Status
Completed
 
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Meldola, Italy, 47014

Status
Completed
 
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Barcelona, Spain, 08025

Status
Completed
 
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Palma de Mallorca, Spain, 07120

Status
Completed
 
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Madrid, Spain, 28041

Status
Completed
 
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Pamplona, Spain, 31008

Status
Completed
 
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Hospitalet de Llobregat, Spain, 08907

Status
Completed
 
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Westmead, Australia, 2145

Status
Completed
 
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Seoul, South Korea, 06273

Status
Completed
 
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Seoul, South Korea, 06591

Status
Completed
 
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Seoul, South Korea, 120-752

Status
Completed
 
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Seoul, South Korea, 05505

Status
Completed
 
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Chomutov, Czech Republic, 430 12

Status
Completed
 
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Praha 5, Czech Republic, 150 06

Status
Completed
 
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Ann Arbor, United States, 48109-0330

Status
Completed
 
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Torino, Italy, 10043

Status
Completed
 
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Toronto, Canada, M4N 3M5

Status
Completed
 
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Santiago, Chile, 7500921

Status
Completed
 
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Busan, South Korea, 49241

Status
Completed
 
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Taipei City, Taiwan, China, 112

Status
Completed
 
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Guishan Township, Taiwan, China, 333

Status
Completed
 
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Kaohsiung, Taiwan, China, 81362

Status
Completed
 
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Northwood, United Kingdom, HA6 2RN

Status
Completed
 
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Taunton, United Kingdom, TA1 5DA

Status
Completed
 
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Karlstad, Sweden, 652 30

Status
Completed
 
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Ottawa, Canada, K1H 8L6

Status
Completed
 
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Toronto, Canada, M5G 2M9

Status
Completed
 
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Taipei, Taiwan, China, 100

Status
Completed
 
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Taichung, Taiwan, China, 40705

Status
Completed
 
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Montreal, Canada, H2L 4M1

Status
Completed
 
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Fort Myers, United States, 33907

Status
Completed
 
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Omaha, United States, 68130

Status
Completed
 
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New Haven, United States, 06520

Status
Completed
 
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VILLEJUIF CEDEX, France, 94805

Status
Completed
 
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NANTES, France, 44805

Status
Completed
 
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Portland, United States, 97239

Status
Completed
 
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East Setauket, United States, 11733

Status
Completed
 
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Vandoeuvre les Nancy, France, 54500

Status
Completed
 
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Investigative Site

Arezzo, Italy, 52100

Status
Completed
 
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IBCC - Instituto Brasileiro de Controle do Cancer

São Paulo, Brazil, 03102 002

Status
Terminated
 
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Investigative Site

London, Canada, N6A 4L6

Status
Completed
 

Trial Design