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

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.

Study Overview

• Status: Completed
• Conditions: Prostatic Neoplasms
• Intervention / Treatment: Drug: Docetaxel; Drug: Placebo; Drug: Prednisone; Drug: Dasatinib

• Study Type: Interventional
• Enrollment (Actual): 1930
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1181ACH
    • Local Institution
  • Buenos Aires, Argentina, C1280AEB
    • Local Institution
  • Buenos Aires, Argentina, C1426ANZ
    • Local Institution
  • Cordaba, Argentina, 5000
    • Local Institution
  • Buenos Aires
    • Caba, Buenos Aires, Argentina, 1417
      • Local Institution
    • Capital Federal, Buenos Aires, Argentina, 1426
      • Local Institution
    • Capital Federal, Buenos Aires, Argentina, 1425
      • Local Institution
    • Capital Federal, Buenos Aires, Argentina, C1405BCJ
      • Local Institution
    • La Plata, Buenos Aires, Argentina, 1900
      • Local Institution
    • Ramos Mejia, Buenos Aires, Argentina, 1234
      • Local Institution
  • Rio Negro
    • Cipolletti, Rio Negro, Argentina, R8324BEH
      • Local Institution
  • Santa Fe
    • Rosario, Santa Fe, Argentina, S2000DSK
      • Local Institution
    • Rosario, Santa Fe, Argentina, S2000CVD
      • Local Institution
  • Tucuman
    • San Miguel De Tucuman, Tucuman, Argentina, T4000IAK
      • Local Institution
• Australia
  • New South Wales
    • Coffs Harbour, New South Wales, Australia, 2450
      • Local Institution
    • Lismore, New South Wales, Australia, 2480
      • Local Institution
    • Port Macquarie, New South Wales, Australia, 2444
      • Local Institution
    • Sydney, New South Wales, Australia, 2076
      • Local Institution
  • Queensland
    • Douglas, Queensland, Australia, 4814
      • Local Institution
    • Milton, Queensland, Australia, 4164
      • Local Institution
  • South Australia
    • Kurralta Park, South Australia, Australia, 5037
      • Local Institution
  • Tasmania
    • Hobart, Tasmania, Australia, 7000
      • Local Institution
  • Victoria
    • Frankston, Victoria, Australia, 3199
      • Local Institution
    • Ringwood, Victoria, Australia, 3135
      • Local Institution
  • Western Australia
    • Fremantle, Western Australia, Australia, 6162
      • Local Institution
• Brazil
  • Rio De Janeiro, Brazil, 20230
    • Local Institution
  • Rio De Janeiro, Brazil, 22551
    • Local Institution
  • Bahia
    • Salvador, Bahia, Brazil, 41950
      • Local Institution
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90610
      • Local Institution
  • Sao Paulo
    • Barretos, Sao Paulo, Brazil, 14784
      • Local Institution
    • Campinas, Sao Paulo, Brazil, 13083
      • Local Institution
    • Jau, Sao Paulo, Brazil, 17210
      • Local Institution
    • Santo Andre, Sao Paulo, Brazil, 09060
      • Local Institution
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Local Institution
  • British Columbia
    • Abbottsford, British Columbia, Canada, V2S 3N5
      • Local Institution
  • New Brunswick
    • Moncton, New Brunswick, Canada, E1C 6Z8
      • Local Institution
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • Local Institution
    • Owen Sound, Ontario, Canada, N4K 2J1
      • Local Institution
    • Sudbury, Ontario, Canada, P3E 5J1
      • Local Institution
    • Thunder Bay, Ontario, Canada, P7B 6V4
      • Local Institution
  • Quebec
    • Greenfield Park, Quebec, Canada, J4V 2H1
      • Local Institution
    • Montreal, Quebec, Canada, H2W 1S6
      • Local Institution
    • Montreal, Quebec, Canada, H2W 1Y5
      • Local Institution
    • Rimouski, Quebec, Canada, G5L 5T1
      • Local Institution
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Local Institution
  • Saskatchewan
    • Regina, Saskatchewan, Canada, S4T 7T1
      • Local Institution
    • Saskatoon, Saskatchewan, Canada, S7N 4H4
      • Local Institution
• Czech Republic
  • Brno, Czech Republic, 656 53
    • Local Institution
  • Hradec Kralove, Czech Republic, 500 05
    • Local Institution
  • Praha 2, Czech Republic, 128 08
    • Local Institution
  • Praha 8, Czech Republic, 180 81
    • Local Institution
• Finland
  • Turku, Finland, 20520
    • Local Institution
  • Vaasa, Finland, 65130
    • Local Institution
• France
  • Avignon, France, 84082
    • Local Institution
  • Besancon Cedex, France, 25030
    • Local Institution
  • Caen, France, 14076
    • Local Institution
  • Creteil, France, 94010
    • Local Institution
  • Paris, France, 75908
    • Local Institution
  • St Genis Laval, France, 69230
    • Local Institution
  • Strasbourg, France, 67085
    • Local Institution
• Germany
  • Aachen, Germany, 52074
    • Local Institution
  • Berlin, Germany, 12200
    • Local Institution
  • Erlangen, Germany, 91054
    • Local Institution
  • Essen, Germany, 45122
    • Local Institution
  • Kirchheim, Germany, 73230
    • Local Institution
  • Markkleeberg, Germany, 04416
    • Local Institution
• Greece
  • Athens, Greece, 11528
    • Local Institution
• Hungary
  • Budapest, Hungary, 1122
    • Local Institution
  • Kecskemet, Hungary, 6000
    • Local Institution
  • Zalaegerszeg, Hungary, 8900
    • Local Institution
• India
  • Ahmedabad, India, 380009
    • Local Institution
  • Jaipur, India, 302013
    • Local Institution
  • Kolkata, India, 700 053
    • Local Institution
  • Kolkatta, India, 700 016
    • Local Institution
  • Kerala
    • Trivandrum, Kerala, India, 695011
      • Local Institution
  • Maharashtra
    • Mumbai, Maharashtra, India, 400026
      • Local Institution
    • Pune, Maharashtra, India, 411001
      • Local Institution
    • Pune, Maharashtra, India, 411004
      • Local Institution
• Ireland
  • Cork, Ireland
    • Local Institution
  • Dublin, Ireland, 7
    • Local Institution
  • Dublin
    • Dublin 7, Dublin, Ireland
      • Local Institution
    • Tallaght, Dublin, Ireland, DUBLIN 24
      • Local Institution
• Italy
  • Arezzo, Italy, 52100
    • Local Institution
  • Genova, Italy, 16132
    • Local Institution
  • Lecce, Italy, 73100
    • Local Institution
  • Milan, Italy, 20141
    • Local Institution
  • Napoli, Italy, 80131
    • Local Institution
  • Perugia, Italy, 06132
    • Local Institution
  • Roma, Italy, 00161
    • Local Institution
• Korea, Republic of
  • Seoul, Korea, Republic of, 120-752
    • Local Institution
  • Seoul, Korea, Republic of, 135-710
    • Local Institution
  • Seoul, Korea, Republic of, 138-736
    • Local Institution
  • Seoul, Korea, Republic of, 135-720
    • Local Institution
• Mexico
  • Baja California
    • Tijuana, Baja California, Mexico, 22010
      • Local Institution
  • Distrito Federal
    • Df, Distrito Federal, Mexico, 06720
      • Local Institution
    • Mexico D.f., Distrito Federal, Mexico, 14050
      • Local Institution
    • Tlalpan, Distrito Federal, Mexico, 14000
      • Local Institution
    • Tlalpan, Distrito Federal, Mexico, 14080
      • Local Institution
  • Estado De Mexico
    • Huixquilucan, Estado De Mexico, Mexico, 52763
      • Local Institution
    • Toluca, Estado De Mexico, Mexico, 50180
      • Local Institution
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44280
      • Local Institution
    • Zapopan, Jalisco, Mexico, 45150
      • Local Institution
  • Nuevo Leon
    • Monterrey, Nuevo Leon, Mexico, 64460
      • Local Institution
  • Queretaro
    • Mexico, Queretaro, Mexico, 76200
      • Local Institution
• Norway
  • Stavanger, Norway, 4068
    • Local Institution
• Peru
  • Callao, Peru, CALLAO 2
    • Local Institution
  • Lima, Peru, LIMA 11
    • Local Institution
  • Lima, Peru, 34
    • Local Institution
  • Lima, Peru, 41
    • Local Institution
  • Lima, Peru, 11
    • Local Institution
  • Lima, Peru, LIMA 29
    • Local Institution
• Poland
  • Bialystok, Poland, 15-027
    • Local Institution
  • Lodz, Poland, 93-509
    • Local Institution
  • Warszawa, Poland, 02-781
    • Local Institution
• Romania
  • Baia Mare, Romania, 430031
    • Local Institution
  • Cluj Napoca, Romania, 400015
    • Local Institution
  • Timisoara, Timis, Romania, 300239
    • Local Institution
• Russian Federation
  • Moscow, Russian Federation, 115478
    • Local Institution
  • Moscow, Russian Federation, 117997
    • Local Institution
  • St Petersburg, Russian Federation, 197758
    • Local Institution
  • St Petersburg, Russian Federation, 197022
    • Local Institution
• South Africa
  • Free State
    • Bloemfontein, Free State, South Africa, 9301
      • Local Institution
  • Gauteng
    • Pretoria, Gauteng, South Africa, 0181
      • Local Institution
    • Saxonwold, Gauteng, South Africa, 2199
      • Local Institution
• Spain
  • Barcelona, Spain, 08208
    • Local Institution
  • Barcelona, Spain, 08003
    • Local Institution
  • Barcelona, Spain, 08025
    • Local Institution
  • Gijon, Spain, 33394
    • Local Institution
  • Madrid, Spain, 28050
    • Local Institution
  • Madrid, Spain, 28033
    • Local Institution
  • Madrid, Spain, 28007
    • Local Institution
  • Santander, Spain, 39008
    • Local Institution
  • Sevilla, Spain, 41013
    • Local Institution
  • Valencia, Spain, 46009
    • Local Institution
• Sweden
  • Kungalv, Sweden, 442 83
    • Local Institution
  • Sundsvall, Sweden, 851 86
    • Local Institution
  • Uppsala, Sweden, 751 85
    • Local Institution
  • Vaxjo, Sweden, 351 85
    • Local Institution
• United Kingdom
  • Essex, United Kingdom, CO3 3NB
    • Local Institution
  • Glamorgan
    • Cardiff, Glamorgan, United Kingdom, CF14 2TL
      • Local Institution
  • Middlesex
    • London, Middlesex, United Kingdom, W12 0NN
      • Local Institution
  • Surrey
    • Sutton, Surrey, United Kingdom, SM2 5PT
      • Local Institution
  • West Yorkshire
    • Leeds, West Yorkshire, United Kingdom, LS8 7TF
      • Local Institution
• United States
  • Alabama
    • Mobile, Alabama, United States, 36608
      • Southern Cancer Center
    • Mobile, Alabama, United States, 36604
      • University Of South Alabama / Mitchell Cancer Institute
  • Alaska
    • Anchorage, Alaska, United States, 99508
      • Alaska Clinical Research Center, LLC
  • Arkansas
    • Fayetteville, Arkansas, United States, 72703
      • Highlands Oncology Group
  • California
    • Corona, California, United States, 92879
      • Compassionate Cancer Care Medical Group, Inc.
    • Rancho Mirage, California, United States, 92270
      • Desert Hematology Oncology Medical Group
    • Riverside, California, United States, 92501
      • Compassionate Cancer Care Medical Group Inc
    • San Diego, California, United States, 92123
      • Sharp Clinical Oncology Research
    • San Diego, California, United States, 92161
      • VA San Diego Healthcare System
    • Santa Ana, California, United States, 92705
      • Edward Alexson, Md, Inc.
  • Connecticut
    • Middletown, Connecticut, United States, 06457
      • Connecticut Oncology Group
    • West Haven, Connecticut, United States, 06516
      • VA Connecticut Healthcare System
  • Georgia
    • Lawrenceville, Georgia, United States, 30046
      • Gwinnett Hospital System Inc.
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago
    • Zion, Illinois, United States, 60099
      • Midwestern Regional Medical Center
  • Indiana
    • Fort Wayne, Indiana, United States, 46845
      • Fort Wayne Medical Oncology And Hematology Inc
  • Kansas
    • Wichita, Kansas, United States, 67214
      • Cancer Center of Kansas
  • Maine
    • Scarborough, Maine, United States, 04074
      • Maine Center for Cancer Medicine
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center
  • Mississippi
    • Jackson, Mississippi, United States, 39202
      • Jackson Oncology Associates, PLLC
    • Tupelo, Mississippi, United States, 38801
      • North Mississippi Hematology And Oncology Associates, Ltd
  • New York
    • Albany, New York, United States, 12208
      • New York Oncology Hematology, PC
    • Albany, New York, United States, 12206
      • New York Oncology Hematology, PC
    • Albany, New York, United States, 12208
      • Samuel S. Stratton Vamc
    • Buffalo, New York, United States, 14263
      • Roswell Park Cancer Institute
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
    • Winston-salem, North Carolina, United States, 27103
      • Piedmont Hematology Oncology Associates, PLLC
  • Ohio
    • Akron, Ohio, United States, 44304
      • SUMMA Health System
    • Columbus, Ohio, United States, 43219
      • Mid Ohio Oncology/Hematology, Inc,Dba
  • Oregon
    • Portland, Oregon, United States, 97213
      • Providence Portland Med Ctr
  • Pennsylvania
    • Langhorne, Pennsylvania, United States, 19047
      • Regional Hemetology Oncology, Pc
    • Pittsburgh, Pennsylvania, United States, 15240
      • VA Pittsburgh Healthcare System
    • Pittsburgh, Pennsylvania, United States, 15232
      • UPMC Cancer Pavilion
    • Upland, Pennsylvania, United States, 19013
      • Associates In Hematology & Oncology, P.C.
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • The Miriam Hospital
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • Cancer Centers of the Carolinas
  • Tennessee
    • Memphis, Tennessee, United States, 38120
      • Boston Baskin Cancer Foundation
  • Texas
    • Corpus Christi, Texas, United States, 78412
      • Cancer Specialists Of South Texas, Pa
    • Houston, Texas, United States, 77030
      • The University of Texas MD Anderson Cancer Center
  • Washington
    • Lacey, Washington, United States, 98503
      • Providence Regional Cancer System
    • Seattle, Washington, United States, 98109
      • University of Washington
  • Wisconsin
    • Madison, Wisconsin, United States, 53717
      • Dean Hematology and Oncology Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Participants 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	Drug: Docetaxel; Drug: Placebo; Drug: Prednisone
Active Comparator: Dasatinib; Participants 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	Drug: Docetaxel; Drug: Prednisone; Drug: Dasatinib; Other Names: BMS-354825; Sprycel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With an Objective Tumor Response by Modified Response Evaluation Criteria in Solid Tumors (RECIST)	Objective tumor response rate=the percentage of randomized participants with a best tumor response of partial (PR) or complete response (CR), within 42 days of end of dosing, divided by total number of patients who were evaluable (with at least 1 target lesion at baseline). By RECIST: CR=disappearance of clinical and radiologic evidence of target and nontarget lesions confirmed by another evaluation at least 6 weeks later. PR=a >30% or greater decrease in the sum of longest diameter (LD) of target lesions in reference to the baseline sum LD confirmed by another evaluation at least 6 weeks later. Stable disease=neither sufficient increase to qualify for PD nor shrinkage to qualify for PR, and at least 8 weeks since start of study therapy. Progressive disease=a 20% or greater increase in sum of LD of all target lesions, taking as reference the smallest sum of LD at or following baseline, or unequivocal progression on existing nontarget lesions, or new lesions are present.	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)	Time to first SRE is defined as the time in months from the date of randomization to the date of first SRE (unless SRE occurred while the patient was undergoing subsequent cancer therapy). Participants with a first SRE while on subsequent cancer therapy, those who died without a reported SRE, and those who did not have an SRE were censored on the date of their last SRE assessment prior to start of subsequent cancer therapy, if any. Participants who had no SRE assessments were censored on the day they were randomized.	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	The percentage of participants who had an on-study uNTx value confirmed (at least 3 weeks later) within normal limits (or ≥3 and <60 nmol/mmol creatinine, if normal limits were missing) or an on-study uNTx level reduction from baseline of ≥35%, even when on-study uNTx value remained abnormal.	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)	PFS is defined as the time from the randomization date until the date of earliest evidence of disease progression or death, for participants who progressed or died before subsequent cancer therapy. Those who progressed or died while on subsequent cancer therapy and those who did not die or progress were censored at their last radiologic bone scan/imaging, skeletal related-event, or tumor assessment or at measurement of prostate specific antigen levels, whichever occurred last prior to start of subsequent cancer therapy ,if any. Participants with no assessments were censored on the day of randomization.	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	PSA progression is defined as the time from randomization to the date of the first PSA level measurement that led to confirmed PSA progression, for participants who had not started subsequent cancer therapy. For participants who did not progress or who progressed on cancer therapy, PSA progression is defined as the time from randomization to the date of the last PSA level measurement before the start of cancer therapy, if any. Participants who had no on-study PSA level measurements were censored on the day they were randomized.	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)
Percentage of Participants With a Reduction in Pain Intensity From Baseline	The percentage of participants with a reduction in pain intensity from baseline was defined as the number of participants who achieved a 30% or more decrease in pain intensity from baseline for at least 2 consecutive pain assessments (at least 14 days apart) within 14 days of end of dosing divided by the number of randomized participants who had a baseline pain intensity of at least 2. Pain intensity was assessed based on question 3 of the brief pain inventory questionnaire.	At baseline, prior to each docetaxel infusion (every 3 weeks), at end of treatment, and at follow-up (within 14 days of end of dosing)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Serious Adverse Event (SAEs), Drug-related SAEs, Drug-related AEs, Drug-related AEs Leading to Discontinuation, and All Deaths	AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=having certain, probable, possible, or missing relationship to study drug	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	AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. AEs of Special Interest=recognized events in other agents within this drug class or events for which safety data from nonclinical and clinical studies with dasatinib indicate that careful evaluation is warranted. Drug-related=having certain, probable, possible, or missing relationship to study drug. Drug-related AEs of Special Interest are identified by the medical and safety representatives of the sponsor based on MedDRA preferred terms or laboratory data. ANC=absolute neutrophil count.	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	Abnormalities were graded according to the Common Toxicity Criteria (CTC), version 3.0, of the National Cancer Institute. CTC are graded from 1 (least severe) to 4 (life threatening ). Grade 3 and 4 criteria are defined as follows: Absolute neutrophil count, Grade 3, neutrophils <1.0-0.5*10^9/L; Grade 4, <0.5*10^9/L. Hemoglobin, Grade 3, <4.9-4.0 mmol/L; Grade 4, <4.0 mmol/L. Platelets, Grade 3, <50.0-25.0*10^9/L; Grade 4, <25.0*10^9/L. Leukocytes, Grade 3, <2.0-1.0*10^9/L; Grade 4, <1.0*10^9/L.	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.
Number of Participants With Abnormalities in Results of Clinical Laboratory Tests Assessing Liver Function, Renal Function, and Electrolytes	ALP=alkaline phosphatase; ALT=alanine aminotransferase; AST=aspartate aminotransferase; ULN=upper limit of normal. Abnormalities were graded according to the Common Toxicity Criteria (CTC), version 3.0, of the National Cancer Institute. CTC are graded from 1 (least severe) to 4 (life threatening). ALP, ALT, and AST, Grade 3, >5.0-20.0*ULN; Grade 4, >20.0*ULN. Total bilirubin, Grade 3, >3.0-10.0*ULN; Grade 4, >10.0*ULN. Creatinine, Grade 3, >3.0-6.0*ULN; Grade 4, >6.0*ULN. Hypercalcemia(serum calcium, mmol/L), Grade 3, >3.1-3.4; Grade 4, >3.4. Hypocalcemia (serum calcium, mmol/L), Grade 3, <1.75-1.5; Grade 4, <1.5. Hyperkalemia(serum calcium, mmol/L), Grade 3, >6.0-7.0; Grade 4, >7.0. Hypokalemia(serum calcium, mmol/L), Grade 3, <3.0-2.5; Grade 4, <2.5. Hypernatremia (serum calcium, mmol/L), Grade 3, >155-160; Grade 4, >160. Hyponatremia (serum sodium, mmol/L), Grade 3, <130-120; Grade 4, <120. Phosphorus (serum sodium, mmol/L), Grade 3, <0.6-0.3; Grade 4, <0.3.	At baseline, within 3 days prior to each infusion of docetaxel (each cycle), to end of treatment. If docetaxel is discontinued, every other cycle.
Number of Participants With Abnormal Results in Urinalysis	Abnormal=positive, defined as the presence of >=30 mg/dL of protein; a small, moderate, or large amount of blood; or >0 g/dL glucose in urine. BL=baseline; neg=negative	At baseline, within 3 days prior to each infusion of docetaxel (each cycle), to end of treatment. If docetaxel is discontinued, every other cycle.
Number of Participants by Maximal On-study Fridericia-corrected QTc Interval	QTc interval measured by electrocardiogram (ECG). Although a participant may have had several ECGs, only the longest QTc interval was included.	At baseline, approximately 12 weeks after starting treatment, and then whenever clinically indicated up to within 30 days of end of dosing
Number of Participants With Changes From Baseline in Fridericia-corrected QTc Interval	QTc interval measured by electrocardiogram (ECG). Although a participant may have had several ECGs, only the longest QTc interval was included.	At baseline, approximately 12 weeks after starting treatment, and then whenever clinically indicated up to within 30 days of end of dosing
Number of Participants With and Without Pericardial Effusion at Baseline and On-study and With Left Ventricular Ejection Fraction (LVEF) <40% and >=40% On-study	BL=baseline; OS=on-study	At baseline, approximately 12 weeks after start of treatment, and thereafter whenever clinically indicated

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

General Publications

• 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.
• Araujo 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.

Helpful Links

• BMS clinical trial educational resource

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: August 29, 2008
• First Submitted That Met QC Criteria: August 29, 2008
• First Posted (Estimate): September 1, 2008

Study Record Updates

• Last Update Posted (Estimate): October 17, 2016
• Last Update Submitted That Met QC Criteria: August 23, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protein Kinase Inhibitors; Docetaxel; Prednisone; Dasatinib
• Other Study ID Numbers: CA180-227; 2008-000701-11 (EudraCT Number)