Randomized Study Comparing Docetaxel Plus Dasatinib to Docetaxel Plus Placebo in Castration-resistant Prostate Cancer
Condition: Prostatic Neoplasms
MeSH terms: Prostatic Neoplasms
Intervention: Placebo; Dasatinib; Docetaxel; Prednisone
Intervention MeSH terms: Prednisone; Docetaxel; Dasatinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1930.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        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.