Randomized Study Comparing Docetaxel Plus Dasatinib to Docetaxel Plus Placebo in Castration-resistant Prostate Cancer
READY
A Randomized Double-Blind Phase 3 Trial Comparing Docetaxel Combined With Dasatinib to Docetaxel Combined With Placebo in Castration-Resistant Prostate Cancer
2 other identifiers
interventional
1,930
25 countries
186
Brief Summary
The purpose of this study is to determine whether survival can be prolonged in patients with castration-resistant prostate cancer who receive dasatinib with docetaxel and prednisone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2008
Longer than P75 for phase_3
186 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 29, 2008
CompletedFirst Posted
Study publicly available on registry
September 1, 2008
CompletedStudy Start
First participant enrolled
October 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedResults Posted
Study results publicly available
February 6, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedOctober 17, 2016
August 1, 2016
3.8 years
August 29, 2008
November 15, 2013
August 23, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Survival: Time From Randomization to Date of Death
Overall survival is defined as time in months from the randomization date to the date of death due to any cause (in the randomized population). If the patient did not die, survival was censored on the last date he or she was known to be alive.
From randomization to death or date of last contact (maximum reached: 45 months)
Secondary Outcomes (6)
Percentage of Participants With an Objective Tumor Response by Modified Response Evaluation Criteria in Solid Tumors (RECIST)
At baseline and every 12 weeks thereafter to end of treatment, at end of treatment, and at follow-up (within 42 days of end of dosing)
Time to First Skeletal-related Event (SRE)
From day of randomization to date of first SRE or to last SRE assessment, if subsequent cancer therapy begun or no SRE (maximum reached: 42 months)
Percentage of Participants With A Reduction in Urinary N-telopeptide (uNTx) Level From Baseline
At baseline, prior to each docetaxel infusion (every 3 weeks) to end of treatment, at end of treatment, and at follow-up (within 14 days of end of dosing)
Progression-free Survival (PFS)
From day of randomization to disease progression or death (or to last clinical assessment, if subsequent cancer therapy started or no progression or death) (maximum reached: approximately 43 months)
Time to Prostate Specific Antigen (PSA) Progression
From randomization to date of first PSA measurement leading to confirmed PSA progression (or to last bone scan assessment, if no progression or if cancer therapy started) (maximum reached: 30 months)
- +1 more secondary outcomes
Other Outcomes (8)
Number of Participants With Serious Adverse Event (SAEs), Drug-related SAEs, Drug-related AEs, Drug-related AEs Leading to Discontinuation, and All Deaths
Continuously throughout study to <=30 days after last dose of study drug; included AEs with an onset date >= day 1 and <= last dose date + 30 days
Number of Participants With Drug-Related Adverse Events (AEs) of Special Interest
Continuously throughout study to <=30 days after last dose of study drug; included AEs with an onset date >= day 1 and <= last dose date + 30 days
Number of Participants With Abnormalities in Results of Clinical Laboratory Tests in Hematology
At baseline, within 3 days prior to each infusion of docetaxel (each cycle) and at end of treatment. If docetaxel is discontinued, every other cycle.
- +5 more other outcomes
Study Arms (2)
Placebo
PLACEBO COMPARATORParticipants received placebo, given orally once daily, plus docetaxel, 75 mg/m\^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
Dasatinib
ACTIVE COMPARATORParticipants received dasatinib, 100 mg, orally once daily plus docetaxel, 75 mg/m\^2, given intravenously every 3 weeks as a 1-hour infusion, plus prednisone, 5 mg, given orally twice daily
Interventions
Eligibility Criteria
You may qualify if:
- History of histologically diagnosed prostate cancer
- Evidence of metastatic disease by any 1 of the following: computed tomography scan, magnetic resonance imaging, bone scan, or skeletal survey
- Evidence of progression, as defined by 1 of the following: rising prostate specific antigen levels at least 1 week apart with the final value being \>=2 ng/mL; progression of measurable nodal or visceral disease, with nodal lesions \>=20 mm and visceral lesions measurable per response evaluation criteria for solid tumors (Response Evaluation in Solid Tumors, version 1); 2 or more lesions appearing on bone scan compared with previous scan; or local recurrence in the prostate or prostate bed
- Maintaining castrate status: Participants who have not undergone surgical orchiectomy should have received and continue on medical therapies, such as gonadotropin releasing hormone analogs, to maintain castrate levels of serum testosterone \<=50 ng/dL
- Eastern Cooperative Oncology Group Performance Status of 0 to 2
- At least 4 weeks since an investigational agent prior to starting study therapy
- At least 8 weeks since radioisotope therapy prior to starting study therapy
- Recovery from any local therapy including surgery or radiation/radiotherapy for a minimum of 7 days prior to starting study therapy
- Required initial laboratory values: white blood cell count \>=3,000/mm\^3; absolute neutrophil count \>=1,500/mm\^3; platelet count \>=100,000/mm\^3; creatinine level \<=1.5\*upper limit of normal (ULN); bilirubin \<=ULN; aspartate aminotransferase \<=2.5\*ULN; alanine aminotransferase \<=2.5\*ULN.
You may not qualify if:
- Symptomatic brain metastases or leptomeningeal metastases
- Clinically significant cardiovascular disease, including myocardial infarction; ventricular tachyarrhythmia within 6 months; prolonged QTc \>450 msec; ejection fraction \<40%; or major conduction abnormality, unless a cardiac pacemaker is present
- Pleural or pericardial effusion of any Common Terminology Criteria (CTC) grade
- Peripheral neuropathy CTC Grade \>=2
- Currently active second malignancy other than nonmelanoma skin cancers. Participants are not considered to have a currently active malignancy if they have completed therapy and are now considered (by their physician) to be at less than 30% risk for relapse
- Uncontrolled intercurrent illness including ongoing or active infection, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- HIV infection-positive patients receiving combination antiretroviral therapy
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to the investigational agents
- Receipt of any other investigational agents for the treatment of prostate cancer
- Prior cytotoxic chemotherapy in the metastatic setting, with the exception of estramustine
- Patients may continue on a daily multivitamin but must discontinue all other herbal, alternative, and food supplements before enrollment
- Ketoconazole must be discontinued 4 weeks prior to starting study therapy
- Antiandrogens must be discontinued prior to starting study therapy. Patients with a history of response to an antiandrogen and subsequent progression while on that antiandrogen should be assessed for antiandrogen withdrawal response for 4 weeks. Observation for antiandrogen withdrawal response is not necessary for those who have never responded to antiandrogens
- Bisphosphonates must not be initiated within 28 days prior to starting study therapy
- QT prolonging agents strongly associated with torsade de pointes.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (186)
University Of South Alabama / Mitchell Cancer Institute
Mobile, Alabama, 36604, United States
Southern Cancer Center
Mobile, Alabama, 36608, United States
Alaska Clinical Research Center, Llc
Anchorage, Alaska, 99508, United States
Highlands Oncology Group
Fayetteville, Arkansas, 72703, United States
Compassionate Cancer Care Medical Group, Inc.
Corona, California, 92879, United States
Desert Hematology Oncology Medical Group
Rancho Mirage, California, 92270, United States
Compassionate Cancer Care Medical Group Inc
Riverside, California, 92501, United States
Sharp Clinical Oncology Research
San Diego, California, 92123, United States
Va San Diego Healthcare System
San Diego, California, 92161, United States
Edward Alexson, Md, Inc.
Santa Ana, California, 92705, United States
Connecticut Oncology Group
Middletown, Connecticut, 06457, United States
Va Connecticut Healthcare System
West Haven, Connecticut, 06516, United States
Gwinnett Hospital System Inc.
Lawrenceville, Georgia, 30046, United States
University Of Chicago
Chicago, Illinois, 60637, United States
Midwestern Regional Medical Center
Zion, Illinois, 60099, United States
Fort Wayne Medical Oncology And Hematology Inc
Fort Wayne, Indiana, 46845, United States
Cancer Center Of Kansas
Wichita, Kansas, 67214, United States
Maine Center For Cancer Medicine
Scarborough, Maine, 04074, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Jackson Oncology Associates, Pllc
Jackson, Mississippi, 39202, United States
North Mississippi Hematology And Oncology Associates, Ltd
Tupelo, Mississippi, 38801, United States
New York Oncology Hematology, Pc
Albany, New York, 12206, United States
New York Oncology Hematology, Pc
Albany, New York, 12208, United States
Samuel S. Stratton Vamc
Albany, New York, 12208, United States
Roswell Park Cancer Institute
Buffalo, New York, 14263, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Piedmont Hematology Oncology Associates, Pllc
Winston-Salem, North Carolina, 27103, United States
Summa Health System
Akron, Ohio, 44304, United States
Mid Ohio Oncology/Hematology, Inc,Dba
Columbus, Ohio, 43219, United States
Providence Portland Med Ctr
Portland, Oregon, 97213, United States
Regional Hemetology Oncology, Pc
Langhorne, Pennsylvania, 19047, United States
Upmc Cancer Pavilion
Pittsburgh, Pennsylvania, 15232, United States
Va Pittsburgh Healthcare System
Pittsburgh, Pennsylvania, 15240, United States
Associates In Hematology & Oncology, P.C.
Upland, Pennsylvania, 19013, United States
The Miriam Hospital
Providence, Rhode Island, 02906, United States
Cancer Centers Of The Carolinas
Greenville, South Carolina, 29615, United States
Boston Baskin Cancer Foundation
Memphis, Tennessee, 38120, United States
Cancer Specialists Of South Texas, Pa
Corpus Christi, Texas, 78412, United States
The University Of Texas Md Anderson Cancer Center
Houston, Texas, 77030, United States
Providence Regional Cancer System
Lacey, Washington, 98503, United States
University Of Washington
Seattle, Washington, 98109, United States
Dean Hematology And Oncology Clinic
Madison, Wisconsin, 53717, United States
Local Institution
Buenos Aires, Buenos Aires, C1181ACH, Argentina
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Buenos Aires, Buenos Aires, C1280AEB, Argentina
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Buenos Aires, Buenos Aires, C1426ANZ, Argentina
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Caba, Buenos Aires, 1417, Argentina
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Capital Federal, Buenos Aires, 1425, Argentina
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Capital Federal, Buenos Aires, 1426, Argentina
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Capital Federal, Buenos Aires, C1405BCJ, Argentina
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La Plata, Buenos Aires, 1900, Argentina
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Ramos Mejía, Buenos Aires, 1234, Argentina
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Cipolletti, Río Negro Province, R8324BEH, Argentina
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Rosario, Santa Fe Province, S2000CVD, Argentina
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Rosario, Santa Fe Province, S2000DSK, Argentina
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San Miguel de Tucumán, Tucumán Province, T4000IAK, Argentina
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Cordaba, 5000, Argentina
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Coffs Harbour, New South Wales, 2450, Australia
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Lismore, New South Wales, 2480, Australia
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Port Macquarie, New South Wales, 2444, Australia
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Sydney, New South Wales, 2076, Australia
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Douglas, Queensland, 4814, Australia
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Milton, Queensland, 4164, Australia
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Kurralta Park, South Australia, 5037, Australia
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Hobart, Tasmania, 7000, Australia
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Frankston, Victoria, 3199, Australia
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Ringwood, Victoria, 3135, Australia
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Fremantle, Western Australia, 6162, Australia
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Salvador, Estado de Bahia, 41950, Brazil
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Rio de Janeiro, Rio de Janeiro, 20230, Brazil
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Rio de Janeiro, Rio de Janeiro, 22551, Brazil
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Porto Alegre, Rio Grande do Sul, 90610, Brazil
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Barretos, São Paulo, 14784, Brazil
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Campinas, São Paulo, 13083, Brazil
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Jaú, São Paulo, 17210, Brazil
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Santo André, São Paulo, 09060, Brazil
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Edmonton, Alberta, T6G 1Z2, Canada
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Abbottsford, British Columbia, V2S 3N5, Canada
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Moncton, New Brunswick, E1C 6Z8, Canada
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Greater Sudbury, Ontario, P3E 5J1, Canada
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Ottawa, Ontario, K1H 8L6, Canada
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Owen Sound, Ontario, N4K 2J1, Canada
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Thunder Bay, Ontario, P7B 6V4, Canada
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Greenfield Park, Quebec, J4V 2H1, Canada
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Montreal, Quebec, H2W 1S6, Canada
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Montreal, Quebec, H2W 1Y5, Canada
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Rimouski, Quebec, G5L 5T1, Canada
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Sherbrooke, Quebec, J1H 5N4, Canada
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Regina, Saskatchewan, S4T 7T1, Canada
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Saskatoon, Saskatchewan, S7N 4H4, Canada
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Brno, 656 53, Czechia
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Hradec Králové, 500 05, Czechia
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Prague, 128 08, Czechia
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Prague, 180 81, Czechia
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Turku, 20520, Finland
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Vaasa, 65130, Finland
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Avignon, 84082, France
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Besançon, 25030, France
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Caen, 14076, France
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Créteil, 94010, France
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Paris, 75908, France
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Saint-Genis-Laval, 69230, France
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Strasbourg, 67085, France
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Aachen, 52074, Germany
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Berlin, 12200, Germany
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Erlangen, 91054, Germany
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Essen, 45122, Germany
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Kirchheim, 73230, Germany
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Markkleeberg, 04416, Germany
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Athens, 11528, Greece
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Budapest, 1122, Hungary
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Kecskemét, 6000, Hungary
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Zalaegerszeg, 8900, Hungary
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Trivandrum, Kerala, 695011, India
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Mumbai, Maharashtra, 400026, India
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Pune, Maharashtra, 411001, India
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Pune, Maharashtra, 411004, India
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Ahmedabad, 380009, India
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Jaipur, 302013, India
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Kolkata, 700 016, India
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Kolkata, 700 053, India
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Cork, Cork, Ireland
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Dublin, Dublin, 7, Ireland
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Dublin, Dublin, Ireland
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Tallaght, Dublin, DUBLIN 24, Ireland
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Arezzo, 52100, Italy
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Genova, 16132, Italy
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Lecce, 73100, Italy
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Milan, 20141, Italy
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Napoli, 80131, Italy
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Perugia, 06132, Italy
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Roma, 00161, Italy
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Tijuana, Estado de Baja California, 22010, Mexico
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Guadalajara, Jalisco, 44280, Mexico
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Zapopan, Jalisco, 45150, Mexico
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Df, Mexico City, 06720, Mexico
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Mexico City, Mexico City, 14050, Mexico
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Tlalpan, Mexico City, 14000, Mexico
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Tlalpan, Mexico City, 14080, Mexico
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Monterrey, Nuevo León, 64460, Mexico
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México, Querétaro, 76200, Mexico
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Huixquilucan, State of Mexico, 52763, Mexico
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Toluca, State of Mexico, 50180, Mexico
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Stavanger, 4068, Norway
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Lima, Lima Province, 11, Peru
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Lima, Lima Province, 34, Peru
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Lima, Lima Province, 41, Peru
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Lima, Lima Province, LIMA 11, Peru
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Lima, Lima Province, LIMA 29, Peru
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Callao, Provincia Constitucional del Callao, CALLAO 2, Peru
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Bialystok, 15-027, Poland
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Lodz, 93-509, Poland
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Warsaw, 02-781, Poland
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Baia Mare, 430031, Romania
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Cluj-Napoca, 400015, Romania
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Timisoara, Timis, 300239, Romania
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Moscow, 115478, Russia
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Moscow, 117997, Russia
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Saint Petersburg, 197022, Russia
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Saint Petersburg, 197758, Russia
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Bloemfontein, Free State, 9301, South Africa
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Pretoria, Gauteng, 0181, South Africa
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Saxonwold, Gauteng, 2199, South Africa
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Seoul, 120-752, South Korea
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Seoul, 135-710, South Korea
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Seoul, 135-720, South Korea
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Seoul, 138-736, South Korea
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Barcelona, 08003, Spain
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Barcelona, 08025, Spain
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Barcelona, 08208, Spain
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Gijón, 33394, Spain
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Madrid, 28007, Spain
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Madrid, 28033, Spain
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Madrid, 28050, Spain
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Santander, 39008, Spain
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Seville, 41013, Spain
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Valencia, 46009, Spain
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Kungälv, 442 83, Sweden
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Sundsvall, 851 86, Sweden
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Uppsala, 751 85, Sweden
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Vaxjo, 351 85, Sweden
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Essex, Essex, CO3 3NB, United Kingdom
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Cardiff, Glamorgan, CF14 2TL, United Kingdom
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London, Middlesex, W12 0NN, United Kingdom
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Sutton, Surrey, SM2 5PT, United Kingdom
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Leeds, West Yorkshire, LS8 7TF, United Kingdom
Related Publications (2)
de Liano AG, Reig O, Mellado B, Martin C, Rull EU, Maroto JP. Prognostic and predictive value of plasma testosterone levels in patients receiving first-line chemotherapy for metastatic castrate-resistant prostate cancer. Br J Cancer. 2014 Apr 29;110(9):2201-8. doi: 10.1038/bjc.2014.189. Epub 2014 Apr 10.
PMID: 24722180DERIVEDAraujo JC, Trudel GC, Saad F, Armstrong AJ, Yu EY, Bellmunt J, Wilding G, McCaffrey J, Serrano SV, Matveev VB, Efstathiou E, Oudard S, Morris MJ, Sizer B, Goebell PJ, Heidenreich A, de Bono JS, Begbie S, Hong JH, Richardet E, Gallardo E, Paliwal P, Durham S, Cheng S, Logothetis CJ. Docetaxel and dasatinib or placebo in men with metastatic castration-resistant prostate cancer (READY): a randomised, double-blind phase 3 trial. Lancet Oncol. 2013 Dec;14(13):1307-16. doi: 10.1016/S1470-2045(13)70479-0. Epub 2013 Nov 8.
PMID: 24211163DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 29, 2008
First Posted
September 1, 2008
Study Start
October 1, 2008
Primary Completion
August 1, 2012
Study Completion
July 1, 2015
Last Updated
October 17, 2016
Results First Posted
February 6, 2014
Record last verified: 2016-08