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:
EudraCT Number:
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site München, Germany, 81675 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tübingen, Germany, 72076 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Dresden, Germany, 01307 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Scottsdale, United States, 85260 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Rockville, United States, 20850 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bethesda, United States, 20889 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site St. Louis, United States, 63110 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Detroit, United States, 48201 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pittsburgh, United States, 15215 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Roma, Italy, 00152 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Göteborg, Sweden, 413 45 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sundsvalls, Sweden, 851 86 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Umeå, Sweden, 901 85 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Beer Sheva, Israel, 8410101 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Petah Tikva, Israel, 4941492 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Jerusalem, Israel, 9112001 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Haifa, Israel, 3109601 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kfar Saba, Israel, 4428164 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ramat Gan, Israel, 5262000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Adelaide, Australia, 5000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Melbourne, Australia, 3052 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Darlinghurst, Australia, 2010 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site BOX HILL, Australia, 3128 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Irmandade Santa Casa de Misericordia de Porto Alegre Porto Alegre, Brazil, 90470 340 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Israelita Albert Einstein São Paulo, Brazil, 05651-901 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital de Clínicas de Porto Alegre Porto Alegre, Brazil | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Instituto do Câncer do Estado de São Paulo São Paulo, Brazil, 01246-000 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bebington, United Kingdom, CH63 4JY | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Meldola, Italy, 47014 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Barcelona, Spain, 08025 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Palma de Mallorca, Spain, 07120 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Madrid, Spain, 28041 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pamplona, Spain, 31008 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hospitalet de Llobregat, Spain, 08907 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Westmead, Australia, 2145 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seoul, South Korea, 06273 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seoul, South Korea, 06591 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seoul, South Korea, 120-752 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Seoul, South Korea, 05505 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chomutov, Czech Republic, 430 12 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Praha 5, Czech Republic, 150 06 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ann Arbor, United States, 48109-0330 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Torino, Italy, 10043 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Toronto, Canada, M4N 3M5 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Santiago, Chile, 7500921 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Busan, South Korea, 49241 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Taipei City, Taiwan, China, 112 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Guishan Township, Taiwan, China, 333 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kaohsiung, Taiwan, China, 81362 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Northwood, United Kingdom, HA6 2RN | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Taunton, United Kingdom, TA1 5DA | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Karlstad, Sweden, 652 30 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ottawa, Canada, K1H 8L6 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Toronto, Canada, M5G 2M9 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Taipei, Taiwan, China, 100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Taichung, Taiwan, China, 40705 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Montreal, Canada, H2L 4M1 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Fort Myers, United States, 33907 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Omaha, United States, 68130 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site New Haven, United States, 06520 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site VILLEJUIF CEDEX, France, 94805 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site NANTES, France, 44805 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Portland, United States, 97239 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site East Setauket, United States, 11733 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Vandoeuvre les Nancy, France, 54500 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Arezzo, Italy, 52100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IBCC - Instituto Brasileiro de Controle do Cancer São Paulo, Brazil, 03102 002 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site London, Canada, N6A 4L6 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A three arm randomized, open-label Phase II study of radium-223 dichloride 50 kBq/kg (55 kBq/kg after implementation of NIST update) versus 80 kBq/kg (88 kBq/kg after implementation of NIST update), and versus 50 kBq/kg (55 kBq/kg after implementation of NIST update) in an extended dosing schedule in subjects with castration-resistant prostate cancer metastatic to the bone
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Open Label
Assignment:
Parallel Assignment
Trial Arms:
3
Primary Outcome
- Symptomatic skeletal event-free survivalTimeframe: From randomization up to a maximum of 8 years, assessed every month during treatment and every 12 weeks during active follow-up
Secondary Outcome
- Overall SurvivalTimeframe: From randomization up to a maximum of 8 years, assessed every month during treatment and every 12 weeks during active follow-up and every 6 months in long term follow-up
- Time to first symptomatic skeletal eventTimeframe: From randomization up to a maximum of 8 years, assessed every month during treatment and every 12 weeks during active follow-up
- Radiological progression free survivalTimeframe: From randomization up to a maximum of 3 years, assessed 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
- Time to radiological progressionTimeframe: From randomization up to a maximum of 3 years, assessed 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
- Pain improvement rate, defined as the number of subjects with pain improvement divided by the total number of subjects evaluable for pain improvementAssessed by Worst Pain Score (WPS) on the Brief Pain Inventory Short Form (BPI-SF)Timeframe: Up to 48 weeks
- Time to pain progressionAssessed by Worst Pain Score (WPS) on the Brief Pain Inventory Short Form (BPI-SF)Timeframe: Up to 48 weeks
- Number of participants with treatment-emergent adverse events or serious adverse events as a measure of safety and tolerabilityIncludes acute and long-term safety, myelo suppression and additional primary malignanciesTimeframe: From randomization up to 8 years
- Change in 24-hour analgesic useTimeframe: Up to 48 weeks
Additional Information
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