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Prostatic NeoplasmsPhase 3READYNCT00744497

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

A Phase 3 study testing Dasatinib, Docetaxel and Prednisone in people with Prostatic Neoplasms, run by Bristol-Myers Squibb at 186 sites in 25 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostatic Neoplasms
What is being tested?
Dasatinib, Docetaxel and Prednisone
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,930 participants
Where
186 sitesin 25 countries
Study dates
Oct 2008to Jul 2015
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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
Show all 15Show fewer
  • 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.

Trial locations and contacts

186 sites in 25 countries.

186 sites in 25 countries

United States43 sites

  • Summa Health System

    Akron, Ohio, 44304

  • New York Oncology Hematology, Pc

    Albany, New York, 12206

  • New York Oncology Hematology, Pc

    Albany, New York, 12208

  • Samuel S. Stratton Vamc

    Albany, New York, 12208

  • Alaska Clinical Research Center, Llc

    Anchorage, Alaska, 99508

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • University Of Chicago

    Chicago, Illinois, 60637

  • Mid Ohio Oncology/Hematology, Inc,Dba

    Columbus, Ohio, 43219

  • Compassionate Cancer Care Medical Group, Inc.

    Corona, California, 92879

  • Cancer Specialists Of South Texas, Pa

    Corpus Christi, Texas, 78412

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Highlands Oncology Group

    Fayetteville, Arkansas, 72703

  • Fort Wayne Medical Oncology And Hematology Inc

    Fort Wayne, Indiana, 46845

  • Cancer Centers Of The Carolinas

    Greenville, South Carolina, 29615

  • The University Of Texas Md Anderson Cancer Center

    Houston, Texas, 77030

  • Jackson Oncology Associates, Pllc

    Jackson, Mississippi, 39202

  • Providence Regional Cancer System

    Lacey, Washington, 98503

  • Regional Hemetology Oncology, Pc

    Langhorne, Pennsylvania, 19047

  • Gwinnett Hospital System Inc.

    Lawrenceville, Georgia, 30046

  • Dean Hematology And Oncology Clinic

    Madison, Wisconsin, 53717

  • Boston Baskin Cancer Foundation

    Memphis, Tennessee, 38120

  • Connecticut Oncology Group

    Middletown, Connecticut, 06457

  • University Of South Alabama / Mitchell Cancer Institute

    Mobile, Alabama, 36604

  • Southern Cancer Center

    Mobile, Alabama, 36608

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Upmc Cancer Pavilion

    Pittsburgh, Pennsylvania, 15232

  • Va Pittsburgh Healthcare System

    Pittsburgh, Pennsylvania, 15240

  • Providence Portland Med Ctr

    Portland, Oregon, 97213

  • The Miriam Hospital

    Providence, Rhode Island, 02906

  • Desert Hematology Oncology Medical Group

    Rancho Mirage, California, 92270

  • Compassionate Cancer Care Medical Group Inc

    Riverside, California, 92501

  • Sharp Clinical Oncology Research

    San Diego, California, 92123

  • Va San Diego Healthcare System

    San Diego, California, 92161

  • Edward Alexson, Md, Inc.

    Santa Ana, California, 92705

  • Maine Center For Cancer Medicine

    Scarborough, Maine, 04074

  • University Of Washington

    Seattle, Washington, 98109

  • North Mississippi Hematology And Oncology Associates, Ltd

    Tupelo, Mississippi, 38801

  • Associates In Hematology & Oncology, P.C.

    Upland, Pennsylvania, 19013

  • Va Connecticut Healthcare System

    West Haven, Connecticut, 06516

  • Cancer Center Of Kansas

    Wichita, Kansas, 67214

  • Piedmont Hematology Oncology Associates, Pllc

    Winston-Salem, North Carolina, 27103

  • Midwestern Regional Medical Center

    Zion, Illinois, 60099

Other trials in United States

Argentina14 sites

  • Local Institution

    Buenos Aires, Buenos Aires, C1181ACH

  • Local Institution

    Buenos Aires, Buenos Aires, C1280AEB

  • Local Institution

    Buenos Aires, Buenos Aires, C1426ANZ

  • Local Institution

    Caba, Buenos Aires, 1417

  • Local Institution

    Capital Federal, Buenos Aires, 1425

  • Local Institution

    Capital Federal, Buenos Aires, 1426

  • Local Institution

    Capital Federal, Buenos Aires, C1405BCJ

  • Local Institution

    Cipolletti, Río Negro Province, R8324BEH

  • Local Institution

    Cordaba, 5000

  • Local Institution

    La Plata, Buenos Aires, 1900

  • Local Institution

    Ramos Mejía, Buenos Aires, 1234

  • Local Institution

    Rosario, Santa Fe Province, S2000CVD

  • Local Institution

    Rosario, Santa Fe Province, S2000DSK

  • Local Institution

    San Miguel de Tucumán, Tucumán Province, T4000IAK

Other trials in Argentina

Canada14 sites

  • Local Institution

    Abbottsford, British Columbia, V2S 3N5

  • Local Institution

    Edmonton, Alberta, T6G 1Z2

  • Local Institution

    Greater Sudbury, Ontario, P3E 5J1

  • Local Institution

    Greenfield Park, Quebec, J4V 2H1

  • Local Institution

    Moncton, New Brunswick, E1C 6Z8

  • Local Institution

    Montreal, Quebec, H2W 1S6

  • Local Institution

    Montreal, Quebec, H2W 1Y5

  • Local Institution

    Ottawa, Ontario, K1H 8L6

  • Local Institution

    Owen Sound, Ontario, N4K 2J1

  • Local Institution

    Regina, Saskatchewan, S4T 7T1

  • Local Institution

    Rimouski, Quebec, G5L 5T1

  • Local Institution

    Saskatoon, Saskatchewan, S7N 4H4

  • Local Institution

    Sherbrooke, Quebec, J1H 5N4

  • Local Institution

    Thunder Bay, Ontario, P7B 6V4

Other trials in Canada

Australia11 sites

  • Local Institution

    Coffs Harbour, New South Wales, 2450

  • Local Institution

    Douglas, Queensland, 4814

  • Local Institution

    Frankston, Victoria, 3199

  • Local Institution

    Fremantle, Western Australia, 6162

  • Local Institution

    Hobart, Tasmania, 7000

  • Local Institution

    Kurralta Park, South Australia, 5037

  • Local Institution

    Lismore, New South Wales, 2480

  • Local Institution

    Milton, Queensland, 4164

  • Local Institution

    Port Macquarie, New South Wales, 2444

  • Local Institution

    Ringwood, Victoria, 3135

  • Local Institution

    Sydney, New South Wales, 2076

Other trials in Australia

Mexico11 sites

  • Local Institution

    Df, Mexico City, 06720

  • Local Institution

    Guadalajara, Jalisco, 44280

  • Local Institution

    Huixquilucan, State of Mexico, 52763

  • Local Institution

    México, Querétaro, 76200

  • Local Institution

    Mexico City, Mexico City, 14050

  • Local Institution

    Monterrey, Nuevo León, 64460

  • Local Institution

    Tijuana, Estado de Baja California, 22010

  • Local Institution

    Tlalpan, Mexico City, 14000

  • Local Institution

    Tlalpan, Mexico City, 14080

  • Local Institution

    Toluca, State of Mexico, 50180

  • Local Institution

    Zapopan, Jalisco, 45150

Other trials in Mexico

Spain10 sites

  • Local Institution

    Barcelona, 08003

  • Local Institution

    Barcelona, 08025

  • Local Institution

    Barcelona, 08208

  • Local Institution

    Gijón, 33394

  • Local Institution

    Madrid, 28007

  • Local Institution

    Madrid, 28033

  • Local Institution

    Madrid, 28050

  • Local Institution

    Santander, 39008

  • Local Institution

    Seville, 41013

  • Local Institution

    Valencia, 46009

Other trials in Spain

Brazil8 sites

  • Local Institution

    Barretos, São Paulo, 14784

  • Local Institution

    Campinas, São Paulo, 13083

  • Local Institution

    Jaú, São Paulo, 17210

  • Local Institution

    Porto Alegre, Rio Grande do Sul, 90610

  • Local Institution

    Rio de Janeiro, Rio de Janeiro, 20230

  • Local Institution

    Rio de Janeiro, Rio de Janeiro, 22551

  • Local Institution

    Salvador, Estado de Bahia, 41950

  • Local Institution

    Santo André, São Paulo, 09060

Other trials in Brazil

India8 sites

  • Local Institution

    Ahmedabad, 380009

  • Local Institution

    Jaipur, 302013

  • Local Institution

    Kolkata, 700 016

  • Local Institution

    Kolkata, 700 053

  • Local Institution

    Mumbai, Maharashtra, 400026

  • Local Institution

    Pune, Maharashtra, 411001

  • Local Institution

    Pune, Maharashtra, 411004

  • Local Institution

    Trivandrum, Kerala, 695011

Other trials in India

France7 sites

  • Local Institution

    Avignon, 84082

  • Local Institution

    Besançon, 25030

  • Local Institution

    Caen, 14076

  • Local Institution

    Créteil, 94010

  • Local Institution

    Paris, 75908

  • Local Institution

    Saint-Genis-Laval, 69230

  • Local Institution

    Strasbourg, 67085

Other trials in France

Italy7 sites

  • Local Institution

    Arezzo, 52100

  • Local Institution

    Genova, 16132

  • Local Institution

    Lecce, 73100

  • Local Institution

    Milan, 20141

  • Local Institution

    Naples, 80131

  • Local Institution

    Perugia, 06132

  • Local Institution

    Roma, 00161

Other trials in Italy

Germany6 sites

  • Local Institution

    Aachen, 52074

  • Local Institution

    Berlin, 12200

  • Local Institution

    Erlangen, 91054

  • Local Institution

    Essen, 45122

  • Local Institution

    Kirchheim, 73230

  • Local Institution

    Markkleeberg, 04416

Other trials in Germany

Peru6 sites

  • Local Institution

    Callao, Provincia Constitucional del Callao, CALLAO 2

  • Local Institution

    Lima, Lima Province, 11

  • Local Institution

    Lima, Lima Province, 34

  • Local Institution

    Lima, Lima Province, 41

  • Local Institution

    Lima, Lima Province, LIMA 11

  • Local Institution

    Lima, Lima Province, LIMA 29

Other trials in Peru

United Kingdom5 sites

  • Local Institution

    Cardiff, Glamorgan, CF14 2TL

  • Local Institution

    Essex, Essex, CO3 3NB

  • Local Institution

    Leeds, West Yorkshire, LS8 7TF

  • Local Institution

    London, Middlesex, W12 0NN

  • Local Institution

    Sutton, Surrey, SM2 5PT

Other trials in United Kingdom

Czechia4 sites

  • Local Institution

    Brno, 656 53

  • Local Institution

    Hradec Králové, 500 05

  • Local Institution

    Prague, 128 08

  • Local Institution

    Prague, 180 81

Other trials in Czechia

Ireland4 sites

  • Local Institution

    Cork, Cork

  • Local Institution

    Dublin, Dublin, 7

  • Local Institution

    Dublin, Dublin

  • Local Institution

    Tallaght, Dublin, DUBLIN 24

Other trials in Ireland

Russia4 sites

  • Local Institution

    Moscow, 115478

  • Local Institution

    Moscow, 117997

  • Local Institution

    Saint Petersburg, 197022

  • Local Institution

    Saint Petersburg, 197758

Other trials in Russia

South Korea4 sites

  • Local Institution

    Seoul, 120-752

  • Local Institution

    Seoul, 135-710

  • Local Institution

    Seoul, 135-720

  • Local Institution

    Seoul, 138-736

Other trials in South Korea

Sweden4 sites

  • Local Institution

    Kungälv, 442 83

  • Local Institution

    Sundsvall, 851 86

  • Local Institution

    Uppsala, 751 85

  • Local Institution

    Vaxjo, 351 85

Other trials in Sweden

Hungary3 sites

  • Local Institution

    Budapest, 1122

  • Local Institution

    Kecskemét, 6000

  • Local Institution

    Zalaegerszeg, 8900

Other trials in Hungary

Poland3 sites

  • Local Institution

    Bialystok, 15-027

  • Local Institution

    Lodz, 93-509

  • Local Institution

    Warsaw, 02-781

Other trials in Poland

Romania3 sites

  • Local Institution

    Baia Mare, 430031

  • Local Institution

    Cluj-Napoca, 400015

  • Local Institution

    Timisoara, Timis, 300239

Other trials in Romania

South Africa3 sites

  • Local Institution

    Bloemfontein, Free State, 9301

  • Local Institution

    Pretoria, Gauteng, 0181

  • Local Institution

    Saxonwold, Gauteng, 2199

Other trials in South Africa

Finland2 sites

  • Local Institution

    Turku, 20520

  • Local Institution

    Vaasa, 65130

Other trials in Finland

Greece1 site

  • Local Institution

    Athens, 11528

Other trials in Greece

Norway1 site

  • Local Institution

    Stavanger, 4068

Other trials in Norway

About this study

Official title: 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.

Being tested
Placebo, Dasatinib, Docetaxel, Prednisone
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00744497
Study groupRoleWhat they receive
PlaceboPlacebo 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
Receives: Drug: Placebo; Drug: Docetaxel; Drug: Prednisone
DasatinibActive 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
Receives: Drug: Dasatinib; Drug: Docetaxel; Drug: Prednisone

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From randomization to death or date of last contact (maximum reached: 45 months)

Secondary outcomes (6)

  1. 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.

    Measured: 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)

  2. 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.

    Measured: 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)

  3. 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.

    Measured: 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)

  4. 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.

    Measured: 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)

  5. 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.

    Measured: 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)

  6. 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.

    Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Sep 2008 (estimated)
  2. Study startOct 2008
  3. Primary completionAug 2012
  4. Study completionJul 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,930 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00744497
Sponsor's protocol ID
CA180-227
Other IDs
2008-000701-11, 2008
Acronym
READY
Status last verified
Aug 2016
First submitted
29 Aug 2008
Last updated
17 Oct 2016
Data monitoring committee
Yes

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.

    PubMed 24722180

  • 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.

    PubMed 24211163

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dasatinib, Docetaxel and Prednisone in people with Prostatic Neoplasms, run by Bristol-Myers Squibb at 186 sites in 25 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 186 sites in United States, Argentina, Canada, Australia, Mexico and 20 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival: Time From Randomization to Date of Death (time frame: From randomization to death or date of last contact (maximum reached: 45 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00744497, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2016.

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READY Clinical Trial NCT00744497 | AzTrials