check_circleStudy Completed
Prostatic Neoplasms
Bayer Identifier:
15396
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Radium-223 dichloride and abiraterone acetate compared to placebo and abiraterone acetate for men with cancer of the prostate when medical or surgical castration does not work and when the cancer has spread to the bone, has not been treated with chemotherapy and is causing no or only mild symptoms
Trial purpose
To determine if the addition of radium-223 dichloride to standard treatment is able to prolong life and to delay events specific for prostate cancer which has spread to the bone, such as painful fractures or bone pain which needs to be treated with an X-ray machine.
Key Participants Requirements
Sex
MaleAge
18 - N/ATrial summary
Enrollment Goal
806Trial Dates
March 2014 - February 2024Phase
Phase 3Could I Receive a placebo
NoProducts
Xofigo (Radium-223 dichloride, BAY88-8223)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Kfar Saba, 4428164, Israel | |
Completed | Haifa, 3109601, Israel | |
Completed | Petach Tikva, 4941492, Israel | |
Completed | Jerusalem, 9112001, Israel | |
Completed | Tel Aviv, 6423906, Israel | |
Completed | Beer Sheva, 8410101, Israel | |
Completed | Ramat Gan, 5262000, Israel | |
Completed | Kuopio, FIN- 70029, Finland | |
Completed | Seinäjoki, 60220, Finland | |
Completed | Helsinki, 00029, Finland | |
Completed | Tampere, 33520, Finland | |
Completed | Berlin, 12203, Germany | |
Completed | Sutton, SM2 5PT, United Kingdom | |
Completed | BRUXELLES - BRUSSEL, 1200, Belgium | |
Completed | GENT, 9000, Belgium | |
Completed | EDEGEM, 2650, Belgium | |
Completed | Romford, RM7 0AG, United Kingdom | |
Completed | Bebington, CH63 4JY, United Kingdom | |
Completed | Northwood, HA6 2VR, United Kingdom | |
Completed | Coventry, CV2 2DX, United Kingdom | |
Completed | Madrid, 28009, Spain | |
Completed | Barcelona, 08035, Spain | |
Completed | Oviedo, 33011, Spain | |
Completed | Hospitalet de Llobregat, 08907, Spain | |
Completed | Barcelona, 8036, Spain | |
Completed | Madrid, 28046, Spain | |
Completed | Pamplona, 31008, Spain | |
Completed | Madrid, 28034, Spain | |
Completed | Madrid, 28033, Spain | |
Completed | Pamplona, 31008, Spain | |
Completed | Badalona, 8916, Spain | |
Completed | Umea, 901 85, Sweden | |
Completed | New Orleans, 70112, United States | |
Completed | Bodø, 8092, Norway | |
Completed | Lørenskog, 1478, Norway | |
Completed | Oslo, 450, Norway | |
Completed | Baltimore, 21201, United States | |
Completed | Detroit, 48202, United States | |
Withdrawn | Scottsdale, 85260, United States | |
Withdrawn | Raleigh, 27607, United States | |
Completed | Seattle, 98109-1023, United States | |
Completed | Rockville, 20850, United States | |
Completed | PARIS, 75010, France | |
Completed | PARIS, 75005, France | |
Withdrawn | grenoble, 38700, France | |
Completed | BESANCON, 25030, France | |
Withdrawn | LILLE CEDEX, 59020, France | |
Completed | Bordeaux Cedex, 33076, France | |
Withdrawn | CAEN CEDEX 5, 14076, France | |
Completed | TOULOUSE CEDEX 9, 31059, France | |
Completed | Sundsvall, 851 86, Sweden | |
Completed | Stockholm, 171 76, Sweden | |
Withdrawn | Aachen, 52074, Germany | |
Terminated | Ulm, 89075, Germany | |
Completed | München, 81675, Germany | |
Completed | Dresden, 1307, Germany | |
Completed | Marburg, 35033, Germany | |
Completed | Pittsburgh, 15219, United States | |
Completed | Gdansk, 80-214, Poland | |
Completed | Gdynia, 81-519, Poland | |
Withdrawn | Warszawa, 02-781, Poland | |
Completed | Gliwice, 44-101, Poland | |
Completed | Cortona, 52040, Italy | |
Completed | Genova, 16128, Italy | |
Completed | Växjö, 351 85, Sweden | |
Completed | Atlanta, 30322, United States | |
Withdrawn | Newark, 19718, United States | |
Completed | ZWOLLE, 8025 AB, Netherlands | |
Completed | AMSTERDAM, 1105 AZ, Netherlands | |
Completed | Fitzroy, 3065, Australia | |
Completed | Sydney, 2010, Australia | |
Completed | Adelaide, 5000, Australia | |
Withdrawn | Birmingham, 35294-7201, United States | |
Completed | Ottawa, K1H 8L6, Canada | |
Completed | Belo Horizonte, 30130-090, Brazil | |
Completed | Boston, 02114-2696, United States | |
Completed | São Paulo, 01246-000, Brazil | |
Completed | Zerifin, 7030000, Israel | |
Completed | East Melbourne, 3002, Australia | |
Completed | Leeds, LS9 7TF, United Kingdom | |
Completed | Belfast, BT9 7AB, United Kingdom | |
Completed | Guildford, GU2 7XX, United Kingdom | |
Completed | Milano, 20133, Italy | |
Withdrawn | Bari, 70124, Italy | |
Completed | Trento, 38100, Italy | |
Completed | Vancouver, V5Z 4E6, Canada | |
Completed | Québec, G1R 2J6, Canada | |
Withdrawn | Lund, 222 42, Sweden | |
Completed | Fort Myers, 33905, United States | |
Withdrawn | Indianapolis, 46202, United States | |
Withdrawn | Bethesda, 20889-5600, United States | |
Withdrawn | Palermo, 90146, Italy | |
Completed | Roma, 152, Italy | |
Completed | Cagliari, 9125, Italy | |
Completed | NIJMEGEN, 6525 GA, Netherlands | |
Withdrawn | AMSTERDAM, 1081 HV, Netherlands | |
Completed | Obninsk, 249036, Russia | |
Completed | Washington, 20007-2113, United States | |
Completed | Barretos/SP, 14784-400, Brazil | |
Completed | Singapore, 168583, Singapore | |
Completed | Singapore, 258499, Singapore | |
Completed | Singapore, 119074, Singapore | |
Withdrawn | Erlangen, 91054, Germany | |
Withdrawn | Mainz, 55101, Germany | |
Completed | Jena, 07747, Germany | |
Withdrawn | Bremen, 28277, Germany | |
Withdrawn | Hannover, 30625, Germany | |
Completed | Porto Alegre, 90020-090, Brazil | |
Withdrawn | Shreveport, 71103, United States | |
Completed | Wheeling, 26003, United States | |
Completed | Spokane, 99208-1129, United States | |
Completed | Burlington, 1805, United States | |
Completed | Hackensack, 7601, United States | |
Completed | Traverse City, 49684, United States | |
Completed | Modena, 41100, Italy | |
Withdrawn | Brescia, 25123, Italy | |
Completed | Roma, 00189, Italy | |
Completed | Linköping, 581 85, Sweden | |
Withdrawn | Singapore, 169608, Singapore | |
Withdrawn | Myrtle Beach, 29577, United States | |
Completed | Tucson, 85704, United States | |
Completed | Winnipeg, R3A 1R9, Canada | |
Completed | Omaha, 68130, United States | |
Completed | Oceanside, 92056, United States | |
Completed | Toronto, M4N 3M5, Canada | |
Completed | Montreal, H2L 4M1, Canada | |
Withdrawn | Scottsdale, 85251, United States | |
Withdrawn | Miami, 33136, United States | |
Completed | Sayama, 589-8511, Japan | |
Completed | Koto-ku, 135-8550, Japan | |
Completed | Bunkyo-Ku, 113-0022, Japan | |
Completed | Sapporo, 003-0804, Japan | |
Completed | Chiba, 260-8717, Japan | |
Completed | Shinjuku-ku, 160-8582, Japan | |
Completed | Kashiwa, 277-8577, Japan | |
Withdrawn | Suita, 565-0871, Japan | |
Completed | Sendai, 980-8574, Japan | |
Completed | Kanazawa, 920-8641, Japan | |
Completed | Bunkyo-ku, 113-8431, Japan | |
Completed | Hamamatsu, 431-3192, Japan | |
Completed | Yokohama, 236-0004, Japan | |
Completed | Edinburgh, EH4 2XU, United Kingdom | |
Completed | Hamilton, L8V 5C2, Canada | |
Completed | Sao Paulo, 01308-050, Brazil | |
Completed | Pittsburgh, 15240, United States | |
Withdrawn | New Haven, 06510, United States | |
Completed | Las Vegas, 89169, United States | |
Withdrawn | Philadelphia, 19104, United States | |
Completed | Norfolk, 23502, United States | |
Completed | Milano, 20141, Italy | |
Completed | Kumamoto, 860-0008, Japan | |
Completed | Okayama-city, 700-8558, Japan | |
Completed | Newcastle Upon Tyne, NE4 6BE, United Kingdom | |
Withdrawn | Dallas, 75246, United States | |
Completed | Münster, 48149, Germany | |
Completed | Moscow, 115478, Russia | |
Withdrawn | Long Beach, 90806, United States | |
Completed | Calgary, T2N 4N2, Canada | |
Completed | Kita-gun, 761-0793, Japan | |
Completed | Sydney, 2031, Australia | |
Completed | Bruxelles, 1070, Belgium | |
Withdrawn | Nedlands, 6009, Australia | |
Completed | Fukuoka, 812-8582, Japan | |
Completed | Matsuyama, 791-0280, Japan | |
Completed | Yokohama, 241-8515, Japan | |
Completed | Miyazaki, 889-1692, Japan | |
Withdrawn | Woodville South, 5011, Australia | |
Completed | Hirosaki, 036-8563, Japan | |
Completed | Heidelberg, 3084, Australia | |
Completed | St Leonards, 2065, Australia | |
Completed | Matsumoto, 390-8621, Japan | |
Completed | Ube, 755-8505, Japan | |
Completed | Nagasaki, 852-8501, Japan | |
Completed | Nagoya, 466-8560, Japan | |
Withdrawn | Nagoya, 460-0001, Japan | |
Completed | Fukuoka, 811-1395, Japan | |
Completed | Poznan, 61-485, Poland | |
Completed | Kurashiki, 701-0192, Japan | |
Withdrawn | Bologna, 40138, Italy | |
Completed | London, NW3 2QG, United Kingdom | |
Completed | Kobe, 650-0047, Japan | |
Completed | Chiba-shi, 260-8677, Japan | |
Completed | Bala Cynwyd, 19004, United States | |
Withdrawn | San Diego, 92123, United States | |
Completed | Saint Louis, 63110, United States | |
Completed | Tsukuba, 305-8576, Japan | |
Completed | East Bentleigh, 3165, Australia | |
Withdrawn | West Columbia, 29169, United States | |
Completed | Towson, 21204, United States | |
Completed | Poughkeepsie, 12601, United States | |
Withdrawn | Detroit, 48201, United States | |
Withdrawn | Omaha, 68130, United States | |
Withdrawn | Scottsdale, 85251, United States | |
Withdrawn | Seattle, 98101-2756, United States | |
Withdrawn | Torrance, 90505, United States | |
Completed | Jeffersonville, 47130, United States | |
Withdrawn | Middleburg Heights, 44130, United States | |
Completed | Denver, 80211, United States | |
Withdrawn | Meridian, 83642, United States | |
Completed | POITIERS, 86021, France | |
Completed | Anchorage, 99503, United States | |
Withdrawn | Shreveport, 71106, United States | |
Withdrawn | Aventura, 33180, United States | |
Withdrawn | Cincinnati, 45212, United States | |
Withdrawn | Springfield, 97477, United States | |
Completed | Syracuse, 13210, United States | |
Withdrawn | Troy, 48084, United States | |
Withdrawn | Los Angeles, 90095, United States | |
Withdrawn | Homewood, 35209, United States | |
Withdrawn | Edison, 8837, United States | |
Withdrawn | Virginia Beach, 23462, United States | |
Withdrawn | Salt Lake City, 84106, United States | |
Withdrawn | Honolulu, 96813, United States | |
Completed | Sevilla, 41071, Spain | |
Completed | Madrid, 28050, Spain | |
Completed | Malaga, 29010, Spain | |
Completed | Saint-Herblain, 44800, France | |
Withdrawn | Dallas, 75390, United States | |
Withdrawn | New York, 10032, United States | |
Withdrawn | Rochester, 14642, United States | |
Withdrawn | Chicago, 60612, United States | |
Withdrawn | Lowell, 01854, United States | |
Withdrawn | Falls Church, 22031, United States | |
Withdrawn | Lebanon, 03756, United States | |
Withdrawn | Sheffield, S10 2SJ, United Kingdom | |
Completed | Tucson, 85704, United States | |
Completed | Afula, 1834111, Israel |
Primary Outcome
- Symptomatic Skeletal Event Free Survival (SSE-FS)SSE-FS was defined as time (months) from randomization to the earliest of onset date of skeletal symptoms treated with external beam radiotherapy (EBRT), onset date of pathological bone fracture, onset date of spinal cord compression, procedure date of tumor-related orthopedic surgery, or death from any cause. Participants who died without prior SSE and ≥ 13 weeks after the last SSE assessment are censored at the last SSE assessment date. Participants alive at the survival cut-off date are censored at the last date known to be alive. Participants with multiple events are only counted for the category in which the first event occurred. If multiple SSE (component events) occur on the same date for 1 participant, the participant is only counted into 1 category in the order of: spinal cord compression > bone fracture > orthopedic surgery > EBRT.date_rangeTime Frame:From randomization until first onset of on-study symptomatic skeletal event (SSE) or death, up to 47 monthsenhanced_encryptionYesSafety Issue:
Secondary Outcome
- Overall Survival (OS)OS was defined as the time (months) from the date of randomization to the date of death due to any cause. Participants alive at the survival cut-off date were censored at the last date known to be alive.date_rangeTime Frame:From randomization until death from any cause, up to 67 monthsenhanced_encryptionYesSafety Issue:
- Radiological Progression Free Survival (rPFS)rPFS was defined as the time (months) from the date of randomization to the date of confirmed radiological progression or death (if death occurred before progression) based on independent assessment.date_rangeTime Frame:From randomization until the date of confirmed radiological progression or death, up to 47 monthsenhanced_encryptionYesSafety Issue:
- Time to Pain ProgressionTime to pain progression was defined as the interval from randomization to the first date a participant experienced pain progression assessed by Brief Pain Inventory-Short Form and defined as: an increase of 2 or more points in the average worst pain score (WPS) from baseline observed at 2 consecutive evaluations ≥4 weeks apart or initiation of short- or long-acting opioid use for pain for participants with WPS 0 at baseline; an increase of 2 or more points in the average WPS from baseline observed at 2 consecutive evaluations ≥4 weeks apart and an average WPS of ≥4 OR initiation of short- or long-acting opioid use for pain for participants with WPS 1 to 3 at baseline. Participants without pain progression at end of study are censored at the last date known to have not progressed: last evaluation date for pain scores or last visit when recorded opiate use, whichever is last. Participants with no on-study assessment or no baseline assessment are censored at the date of randomization.date_rangeTime Frame:From randomization until the date of pain progression based on pain score, up to 47 monthsenhanced_encryptionYesSafety Issue:
- Time to Cytotoxic ChemotherapyTime to cytotoxic chemotherapy is time (months) from randomization to the earliest date of the first cytotoxic chemotherapy. Participants who have not started cytotoxic chemotherapy during the study were censored at the last assessment date.date_rangeTime Frame:From randomization until the date of first cytotoxic chemotherapy, up to 47 monthsenhanced_encryptionYesSafety Issue:
- Time to Opiate Use for Cancer PainTime to opiate use for cancer pain was defined as the interval from the date of randomization to the date of opiate use.date_rangeTime Frame:From randomization until the date of opiate use, up to 47 monthsenhanced_encryptionYesSafety Issue:
- Number of participants with treatment-emergent adverse eventsAn adverse event (AE) was any untoward medical occurrence (i.e., any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a participant in the study. A serious adverse event (SAE) was any untoward medical occurrence that at any dose was resulting in death, was life-threatening, requires hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity. A treatment-emergent AEs (TEAEs) or serious TEAEs was defined as any event that started on or after the first dose of the study treatment and during the treatment period and was not a continuation of a pretreatment event or started before the first dose and worsened after the first dose or the treatment period. Drug-related TEAEs or serious TEAEs were those with "reasonable causal relationship" to the study treatment decided by the investigators.date_rangeTime Frame:From start of study treatment until the end of the treatment period, up to 110 months
- Number of participants with radium-223/placebo-related treatment-emergent adverse events per maximum intensityAn adverse event (AE) was any untoward medical occurrence (i.e., any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a participant in the study. A serious adverse event (SAE) was any untoward medical occurrence that at any dose was resulting in death, was lifethreatening, requires hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity. A treatment-emergent AEs (TEAEs) or serious TEAEs was defined as any event that started on or after the first dose of the study treatment and during the treatment period and was not a continuation of a pretreatment event or started before the first dose and worsened after the first dose or the treatment period. Radium-223/placebo-related TEAEs or serious TEAEs were those with "reasonable causal relationship" to radium-223 or placebo decided by the investigators.date_rangeTime Frame:From start of study treatment until the end of the treatment period, up to 110 months
- Number of participants with any treatment-emergent additional primary malignanciesTreatment-emergent additional primary malignancies were adverse events identified as additional primary malignancies that occurred after start of study treatment until the end of the treatment period.date_rangeTime Frame:From start of study treatment until the end of the treatment period, up to 110 months
- Number of participants with treatment-emergent bone fracturesTreatment-emergent fractures were adverse events identified as fractures that occurred after start of study treatment until the end of the treatment period. All bone fractures and bone-associated events (e.g., osteoporosis) were reported as either AEs, or SAEs if the criteria of SAE were met, regardless of the investigator’s causality assessment.date_rangeTime Frame:From start of study treatment until the end of the treatment period, up to 110 months
- Number of participants with post-treatment adverse eventsAn adverse event (AE) was any untoward medical occurrence (i.e., any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a participant in the study. Any bleeding event occurring during the study was not documented as an AE because this event was planned to be captured in the assessment of efficacy. AEs that started after the treatment period were defined as post-treatment AEs. Drug-related AEs were those with "reasonable causal relationship" to the study treatment decided by the investigators.date_rangeTime Frame:After the treatment period, up to 48.5 months in active follow-up and 74.9 months in long-term follow-up
- Number of participants with any study drug-related post-treatment adverse events per maximum intensityAn adverse event (AE) was any untoward medical occurrence (i.e., any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a participant in the study. Any bleeding event occurring during the study was not documented as an AE because this event was planned to be captured in the assessment of efficacy. AEs that started after the treatment period were defined as post-treatment AEs. Drug-related AEs were those with "reasonable causal relationship" to the study treatment decided by the investigators.date_rangeTime Frame:After the treatment period, up to 48.5 months in active follow-up and 74.9 months in long-term follow-up
- Number of participants with post-treatment additional primary malignanciesPost-treatment additional primary malignancies were adverse events identified as additional primary malignancies that started after the treatment period.date_rangeTime Frame:After the treatment period, up to 48.5 months in active follow-up and 74.9 months in long-term follow-up
- Number of participants with post-treatment chemotherapy-related blood and lymphatic system disordersPost-treatment blood and lymphatic system disorders were adverse events identified as blood and lymphatic system disorders that occurred after the end of the treatment period until participant died, was lost to follow-up, withdrew informed consent, actively objected to collection of further data, or was transitioned to the extended safety follow-up study.date_rangeTime Frame:After the treatment period, up to 48.5 months in active follow-up and 74.9 months in long-term follow-up
- Number of participants with post-treatment bone fracturesPost-treatment fractures were adverse events identified as fractures that occured after the end of the treatment period until participant died, was lost to follow-up, withdrew informed consent, actively objected to collection of further data, or was transitioned to the extended safety follow-up study. All bone fractures and bone-associated events (e.g., osteoporosis), were reported as either AEs, or SAEs if the criteria of SAE were met, regardless of the investigator’s causality assessment.date_rangeTime Frame:After the treatment period, up to 48.5 months in active follow-up and 74.9 months in long-term follow-up
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
2