check_circleStudy Completed
Prostatic Neoplasms
Bayer Identifier:
16507
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Standard dose versus high dose and versus extended standard dose radium-223 dichloride in castration-resistant prostate cancer metastatic to the bone
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.
Key Participants Requirements
Sex
MaleAge
18 - N/ATrial summary
Enrollment Goal
391Trial Dates
March 2014 - August 2018Phase
Phase 2Could I Receive a placebo
NoProducts
Xofigo (Radium-223 dichloride, BAY88-8223)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | München, 81675, Germany | |
Withdrawn | Ulm, 89081, Germany | |
Completed | Tübingen, 72076, Germany | |
Completed | Dresden, 01307, Germany | |
Withdrawn | Belfast, BT9 7AB, United Kingdom | |
Completed | Scottsdale, 85260, United States | |
Completed | Rockville, 20850, United States | |
Withdrawn | Seattle, 98109, United States | |
Completed | Bethesda, 20889, United States | |
Completed | St. Louis, 63110, United States | |
Completed | Detroit, 48201, United States | |
Completed | Pittsburgh, 15215, United States | |
Completed | Roma, 00152, Italy | |
Withdrawn | Reggio Emilia, 42123, Italy | |
Withdrawn | Pisa, 56126, Italy | |
Withdrawn | Genova, 16128, Italy | |
Withdrawn | Milano, 20162, Italy | |
Completed | Göteborg, 413 45, Sweden | |
Completed | Sundsvalls, 851 86, Sweden | |
Completed | Umeå, 901 85, Sweden | |
Completed | Beer Sheva, 8410101, Israel | |
Completed | Petah Tikva, 4941492, Israel | |
Completed | Jerusalem, 9112001, Israel | |
Completed | Haifa, 3109601, Israel | |
Completed | Kfar Saba, 4428164, Israel | |
Completed | Ramat Gan, 5262000, Israel | |
Completed | Adelaide, 5000, Australia | |
Completed | Melbourne, 3052, Australia | |
Completed | Darlinghurst, 2010, Australia | |
Completed | BOX HILL, 3128, Australia | |
Terminated | Irmandade Santa Casa de Misericordia de Porto Alegre | Porto Alegre, 90470 340, Brazil |
Terminated | Hospital Israelita Albert Einstein | São Paulo, 05651-901, Brazil |
Terminated | Hospital de Clínicas de Porto Alegre | Porto Alegre, Brazil |
Terminated | Instituto do Câncer do Estado de São Paulo | São Paulo, 01246-000, Brazil |
Withdrawn | HUS, 00029, Finland | |
Withdrawn | Seinäjoki, 60220, Finland | |
Withdrawn | Erlangen, 91054, Germany | |
Completed | Bebington, CH63 4JY, United Kingdom | |
Completed | Meldola, 47014, Italy | |
Withdrawn | Bari, 70124, Italy | |
Withdrawn | Padova, 35128, Italy | |
Withdrawn | Cordoba, 14004, Spain | |
Completed | Barcelona, 08025, Spain | |
Completed | Palma de Mallorca, 07120, Spain | |
Completed | Madrid, 28041, Spain | |
Completed | Pamplona, 31008, Spain | |
Completed | Hospitalet de Llobregat, 08907, Spain | |
Completed | Westmead, 2145, Australia | |
Completed | Seoul, 06273, Korea, Republic Of | |
Completed | Seoul, 06591, Korea, Republic Of | |
Completed | Seoul, 120-752, Korea, Republic Of | |
Completed | Seoul, 05505, Korea, Republic Of | |
Withdrawn | Manchester, M20 4BX, United Kingdom | |
Withdrawn | Usti nad Labem, 401 13, Czech Republic | |
Completed | Chomutov, 430 12, Czech Republic | |
Completed | Praha 5, 150 06, Czech Republic | |
Withdrawn | Praha 2, 128 08, Czech Republic | |
Completed | Ann Arbor, 48109-0330, United States | |
Withdrawn | Gliwice, 44-101, Poland | |
Withdrawn | Krakow, 31-501, Poland | |
Completed | Torino, 10043, Italy | |
Completed | Toronto, M4N 3M5, Canada | |
Completed | Santiago, 7500921, Chile | |
Completed | Busan, 49241, Korea, Republic Of | |
Completed | Taipei City, 112, Taiwan | |
Completed | Guishan Township, 333, Taiwan | |
Completed | Kaohsiung, 81362, Taiwan | |
Completed | Northwood, HA6 2RN, United Kingdom | |
Completed | Taunton, TA1 5DA, United Kingdom | |
Completed | Karlstad, 652 30, Sweden | |
Completed | Ottawa, K1H 8L6, Canada | |
Completed | Toronto, M5G 2M9, Canada | |
Completed | Taipei, 100, Taiwan | |
Completed | Taichung, 40705, Taiwan | |
Completed | Montreal, H2L 4M1, Canada | |
Withdrawn | New Hyde Park, 11040-1496, United States | |
Completed | Fort Myers, 33907, United States | |
Completed | Omaha, 68130, United States | |
Completed | New Haven, 06520, United States | |
Withdrawn | PARIS CEDEX 15, 75908, France | |
Completed | VILLEJUIF CEDEX, 94805, France | |
Completed | NANTES, 44805, France | |
Withdrawn | POITIERS, 86021, France | |
Withdrawn | SAINT-CLOUD, 92210, France | |
Completed | Portland, 97239, United States | |
Completed | East Setauket, 11733, United States | |
Completed | Vandoeuvre les Nancy, 54500, France | |
Completed | Arezzo, 52100, Italy | |
Terminated | IBCC - Instituto Brasileiro de Controle do Cancer | São Paulo, 03102 002, Brazil |
Withdrawn | Barcelona, 08035, Spain | |
Withdrawn | Seattle, 98101, United States | |
Completed | London, N6A 4L6, Canada |
Primary Outcome
- Symptomatic skeletal event-free survivaldate_rangeTime Frame:From randomization up to a maximum of 8 years, assessed every month during treatment and every 12 weeks during active follow-upenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Overall Survivaldate_rangeTime Frame: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-upenhanced_encryptionNoSafety Issue:
- Time to first symptomatic skeletal eventdate_rangeTime Frame:From randomization up to a maximum of 8 years, assessed every month during treatment and every 12 weeks during active follow-upenhanced_encryptionNoSafety Issue:
- Radiological progression free survivaldate_rangeTime Frame: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 tissueenhanced_encryptionNoSafety Issue:
- Time to radiological progressiondate_rangeTime Frame: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 tissueenhanced_encryptionNoSafety Issue:
- 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)date_rangeTime Frame:Up to 48 weeksenhanced_encryptionNoSafety Issue:
- Time to pain progressionAssessed by Worst Pain Score (WPS) on the Brief Pain Inventory Short Form (BPI-SF)date_rangeTime Frame:Up to 48 weeksenhanced_encryptionNoSafety Issue:
- 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 malignanciesdate_rangeTime Frame:From randomization up to 8 yearsenhanced_encryptionYesSafety Issue:
- Change in 24-hour analgesic usedate_rangeTime Frame:Up to 48 weeksenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Open LabelAssignment
Parallel AssignmentTrial Arms
3