Randomized Study Comparing Docetaxel Plus Dasatinib to Docetaxel Plus Placebo in Castration-resistant Prostate Cancer

Prostatic Neoplasms Clinical Trial

— READY  

Official title:

A Randomized Double-Blind Phase 3 Trial Comparing Docetaxel Combined With Dasatinib to Docetaxel Combined With Placebo in Castration-Resistant Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00744497
• Other study ID #: CA180-227
• Secondary ID: 2008-000701-11
• Status: Completed
• Phase: Phase 3
• First received: August 29, 2008
• Last updated: August 13, 2015
• Start date: October 2008
• Est. completion date: July 2015

Study information

• Verified date: August 2015
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaAustralia: Department of Health and Ageing Therapeutic Goods AdministrationBrazil: National Committee of Ethics in ResearchCanada: Health CanadaCzech Republic: State Institute for Drug ControlFinland: Finnish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesGreece: National Organization of MedicinesHungary: National Institute of PharmacyIndia: Drugs Controller General of IndiaIreland: Irish Medicines BoardItaly: Ministry of HealthKorea: Food and Drug AdministrationMexico: Federal Commission for Sanitary Risks ProtectionNorway:National Committee for Medical and Health Research EthicsPeru: Health National InstitutePoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsRomania: National Medicines AgencyRussia: FSI Scientific Center of Expertise of Medical ApplicationSouth Africa: Medicines Control CouncilSpain: Spanish Agency of MedicinesSweden: Medical Products AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1930
• Est. completion date: July 2015
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostatic Neoplasms

Intervention

Drug:
• Placebo

• Dasatinib

• Docetaxel

• Prednisone

Locations

Country	Name	City	State
Argentina	Local Institution	Buenos Aires
Argentina	Local Institution	Buenos Aires
Argentina	Local Institution	Buenos Aires
Argentina	Local Institution	Caba	Buenos Aires
Argentina	Local Institution	Capital Federal	Buenos Aires
Argentina	Local Institution	Capital Federal	Buenos Aires
Argentina	Local Institution	Capital Federal	Buenos Aires
Argentina	Local Institution	Cipolletti	Rio Negro
Argentina	Local Institution	Cordaba
Argentina	Local Institution	La Plata	Buenos Aires
Argentina	Local Institution	Ramos Mejia	Buenos Aires
Argentina	Local Institution	Rosario	Santa Fe
Argentina	Local Institution	Rosario	Santa Fe
Argentina	Local Institution	San Miguel De Tucuman	Tucuman
Australia	Local Institution	Coffs Harbour	New South Wales
Australia	Local Institution	Douglas	Queensland
Australia	Local Institution	Frankston	Victoria
Australia	Local Institution	Fremantle	Western Australia
Australia	Local Institution	Hobart	Tasmania
Australia	Local Institution	Kurralta Park	South Australia
Australia	Local Institution	Lismore	New South Wales
Australia	Local Institution	Milton	Queensland
Australia	Local Institution	Port Macquarie	New South Wales
Australia	Local Institution	Ringwood	Victoria
Australia	Local Institution	Sydney	New South Wales
Brazil	Local Institution	Barretos	Sao Paulo
Brazil	Local Institution	Campinas	Sao Paulo
Brazil	Local Institution	Jau	Sao Paulo
Brazil	Local Institution	Porto Alegre	Rio Grande Do Sul
Brazil	Local Institution	Rio De Janeiro
Brazil	Local Institution	Rio De Janeiro
Brazil	Local Institution	Salvador	Bahia
Brazil	Local Institution	Santo Andre	Sao Paulo
Canada	Local Institution	Abbottsford	British Columbia
Canada	Local Institution	Edmonton	Alberta
Canada	Local Institution	Greenfield Park	Quebec
Canada	Local Institution	Moncton	New Brunswick
Canada	Local Institution	Montreal	Quebec
Canada	Local Institution	Montreal	Quebec
Canada	Local Institution	Ottawa	Ontario
Canada	Local Institution	Owen Sound	Ontario
Canada	Local Institution	Regina	Saskatchewan
Canada	Local Institution	Rimouski	Quebec
Canada	Local Institution	Saskatoon	Saskatchewan
Canada	Local Institution	Sherbrooke	Quebec
Canada	Local Institution	Sudbury	Ontario
Canada	Local Institution	Thunder Bay	Ontario
Czech Republic	Local Institution	Brno
Czech Republic	Local Institution	Hradec Kralove
Czech Republic	Local Institution	Praha 2
Czech Republic	Local Institution	Praha 8
Finland	Local Institution	Turku
Finland	Local Institution	Vaasa
France	Local Institution	Avignon
France	Local Institution	Besancon Cedex
France	Local Institution	Caen
France	Local Institution	Creteil
France	Local Institution	Paris
France	Local Institution	St Genis Laval
France	Local Institution	Strasbourg
Germany	Local Institution	Aachen
Germany	Local Institution	Berlin
Germany	Local Institution	Erlangen
Germany	Local Institution	Essen
Germany	Local Institution	Kirchheim
Germany	Local Institution	Markkleeberg
Greece	Local Institution	Athens
Hungary	Local Institution	Budapest
Hungary	Local Institution	Kecskemet
Hungary	Local Institution	Zalaegerszeg
India	Local Institution	Ahmedabad
India	Local Institution	Jaipur
India	Local Institution	Kolkata
India	Local Institution	Kolkatta
India	Local Institution	Mumbai	Maharashtra
India	Local Institution	Pune	Maharashtra
India	Local Institution	Pune	Maharashtra
India	Local Institution	Trivandrum	Kerala
Ireland	Local Institution	Cork
Ireland	Local Institution	Dublin
Ireland	Local Institution	Dublin 7	Dublin
Ireland	Local Institution	Tallaght	Dublin
Italy	Local Institution	Arezzo
Italy	Local Institution	Genova
Italy	Local Institution	Lecce
Italy	Local Institution	Milan
Italy	Local Institution	Napoli
Italy	Local Institution	Perugia
Italy	Local Institution	Roma
Korea, Republic of	Local Institution	Seoul
Korea, Republic of	Local Institution	Seoul
Korea, Republic of	Local Institution	Seoul
Korea, Republic of	Local Institution	Seoul
Mexico	Local Institution	Df	Distrito Federal
Mexico	Local Institution	Guadalajara	Jalisco
Mexico	Local Institution	Huixquilucan	Estado De Mexico
Mexico	Local Institution	Mexico	Queretaro
Mexico	Local Institution	Mexico D.f.	Distrito Federal
Mexico	Local Institution	Monterrey	Nuevo Leon
Mexico	Local Institution	Tijuana	Baja California
Mexico	Local Institution	Tlalpan	Distrito Federal
Mexico	Local Institution	Tlalpan	Distrito Federal
Mexico	Local Institution	Toluca	Estado De Mexico
Mexico	Local Institution	Zapopan	Jalisco
Norway	Local Institution	Stavanger
Peru	Local Institution	Callao
Peru	Local Institution	Lima
Peru	Local Institution	Lima
Peru	Local Institution	Lima
Peru	Local Institution	Lima
Peru	Local Institution	Lima
Poland	Local Institution	Bialystok
Poland	Local Institution	Lodz
Poland	Local Institution	Warszawa
Romania	Local Institution	Baia Mare
Romania	Local Institution	Cluj Napoca
Romania	Local Institution	Timisoara, Timis
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	St Petersburg
Russian Federation	Local Institution	St Petersburg
South Africa	Local Institution	Bloemfontein	Free State
South Africa	Local Institution	Pretoria	Gauteng
South Africa	Local Institution	Saxonwold	Gauteng
Spain	Local Institution	Barcelona
Spain	Local Institution	Barcelona
Spain	Local Institution	Barcelona
Spain	Local Institution	Gijon
Spain	Local Institution	Madrid
Spain	Local Institution	Madrid
Spain	Local Institution	Madrid
Spain	Local Institution	Santander
Spain	Local Institution	Sevilla
Spain	Local Institution	Valencia
Sweden	Local Institution	Kungalv
Sweden	Local Institution	Sundsvall
Sweden	Local Institution	Uppsala
Sweden	Local Institution	Vaxjo
United Kingdom	Local Institution	Cardiff	Glamorgan
United Kingdom	Local Institution	Essex
United Kingdom	Local Institution	Leeds	West Yorkshire
United Kingdom	Local Institution	London	Middlesex
United Kingdom	Local Institution	Sutton	Surrey
United States	Summa Health System	Akron	Ohio
United States	New York Oncology Hematology, Pc	Albany	New York
United States	New York Oncology Hematology, Pc	Albany	New York
United States	Samuel S. Stratton Vamc	Albany	New York
United States	Alaska Clinical Research Center, Llc	Anchorage	Alaska
United States	Tufts Medical Center	Boston	Massachusetts
United States	Roswell Park Cancer Institute	Buffalo	New York
United States	University Of Chicago	Chicago	Illinois
United States	Mid Ohio Oncology/Hematology, Inc,Dba	Columbus	Ohio
United States	Compassionate Cancer Care Medical Group, Inc.	Corona	California
United States	Cancer Specialists Of South Texas, Pa	Corpus Christi	Texas
United States	Duke University Medical Center	Durham	North Carolina
United States	Highlands Oncology Group	Fayetteville	Arkansas
United States	Fort Wayne Medical Oncology And Hematology Inc	Fort Wayne	Indiana
United States	Cancer Centers Of The Carolinas	Greenville	South Carolina
United States	The University Of Texas Md Anderson Cancer Center	Houston	Texas
United States	Jackson Oncology Associates, Pllc	Jackson	Mississippi
United States	Providence Regional Cancer System	Lacey	Washington
United States	Regional Hemetology Oncology, Pc	Langhorne	Pennsylvania
United States	Gwinnett Hospital System Inc.	Lawrenceville	Georgia
United States	Dean Hematology And Oncology Clinic	Madison	Wisconsin
United States	Boston Baskin Cancer Foundation	Memphis	Tennessee
United States	Connecticut Oncology Group	Middletown	Connecticut
United States	Southern Cancer Center	Mobile	Alabama
United States	University Of South Alabama / Mitchell Cancer Institute	Mobile	Alabama
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Upmc Cancer Pavilion	Pittsburgh	Pennsylvania
United States	Va Pittsburgh Healthcare System	Pittsburgh	Pennsylvania
United States	Providence Portland Med Ctr	Portland	Oregon
United States	The Miriam Hospital	Providence	Rhode Island
United States	Desert Hematology Oncology Medical Group	Rancho Mirage	California
United States	Compassionate Cancer Care Medical Group Inc	Riverside	California
United States	Sharp Clinical Oncology Research	San Diego	California
United States	Va San Diego Healthcare System	San Diego	California
United States	Edward Alexson, Md, Inc.	Santa Ana	California
United States	Maine Center For Cancer Medicine	Scarborough	Maine
United States	University Of Washington	Seattle	Washington
United States	North Mississippi Hematology And Oncology Associates, Ltd	Tupelo	Mississippi
United States	Associates In Hematology & Oncology, P.C.	Upland	Pennsylvania
United States	Va Connecticut Healthcare System	West Haven	Connecticut
United States	Cancer Center Of Kansas	Wichita	Kansas
United States	Piedmont Hematology Oncology Associates, Pllc	Winston-salem	North Carolina
United States	Midwestern Regional Medical Center	Zion	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Brazil,  Canada,  Czech Republic,  Finland,  France,  Germany,  Greece,  Hungary,  India,  Ireland,  Italy,  Korea, Republic of,  Mexico,  Norway,  Peru,  Poland,  Romania,  Russian Federation,  South Africa,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs) Leading to Discontinuation, and Drug-related AEs Leading to Discontinuation	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 until resolution of drug-related toxicity, or when toxicity was deemed irreversible, whichever shorter.	Yes
Other	Number of Participants With 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. 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 until resolution of drug-related toxicity, or when toxicity was deemed irreversible, whichever was shorter	Yes
Other	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.	Yes
Other	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.	Yes
Other	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.	Yes
Other	Number of Participants by Maximal On-study Fridericia-corrected QTc Interval by Electrocardiogram		At baseline, approximately 12 weeks after starting treatment, and then whenever clinically indicated up to within 30 days of end of dosing	Yes
Other	Number of Participants With Changes From Baseline in Fridericia-corrected QTc Interval by Electrocardiogram		At baseline, approximately 12 weeks after starting treatment, and then whenever clinically indicated up to within 30 days of end of dosing	Yes
Other	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 by Echocardiogram	BL=baseline; OS=on-study	At baseline, approximately 12 weeks after start of treatment, and thereafter whenever clinically indicated	Yes
Primary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No

External Links

•   BMS clinical trial educational resource
•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry form