Clinical trial NCT01826838 (phase 1, status: withdrawn)
Conditions: prostate cancer
ICD codes: C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5
Drugs: dasatinib
SMILES: CC1=NC(NC2=NC=C(S2)C(=O)NC2=C(C)C=CC=C2Cl)=CC(=N1)N1CCN(CCO)CC1
Reason stopped: 
    lack of patients
  
Eligibility criteria:

        PATIENT ELIGIBILITY

        -Conditions for Patient Eligibility

        Each patient must meet all of the following inclusion criteria to be enrolled in the study:

          -  Histologically or pathologically confirmed adenocarcinoma of the prostate to be
             treated with radiation therapy and hormone therapy.

          -  Intermediate, high or very high risk disease

               -  Intermediate-risk disease (clinical T2b or T2c stage or PSA 10 to 20 ng/mL or
                  Gleason score 7)

               -  High-risk disease (Gleason score 8 to 10, serum PSA > 20 ng/mL or T3a disease)

               -  Very high-risk disease (T3b or T4)

          -  No prior pelvic or prostate radiation or chemotherapy for prostate cancer.

          -  Clinically negative lymph nodes as established by imaging (pelvic CT or pelvic MR),
             nodal sampling or dissection within 8 weeks prior to registration. Patients with lymph
             nodes equivocal or questionable by imaging are eligible if the nodes are < 1.5 cm.

          -  Bone scan within 12 weeks prior to registration. Equivocal bone scan findings are
             allowed if plain films are negative for metastasis.

          -  ECOG performance status 0-1

          -  Age > 18

          -  Required entry laboratory parameters within 14 days of study entry: Granulocytes ≥
             1500/µl; platelet count ≥ 100,000/µl; Hgb > 8.0 g/dl; Creatinine < 1.5 x the
             institutional ULN, mg/dl; Bilirubin ≤ 2x institutional upper limit of normal; AST ≤
             2.5 x upper limit of normal, Serum Na+, K+, Mg2+, Phosphate and Calcium within
             institutional normal range; PT and PTT < 1.5 ULN

          -  Life expectancy of at least 1 year

          -  No concurrent anticancer therapy.

          -  Peripheral neuropathy must be ≤ Grade 2

          -  A male subject of fathering potential must use an adequate method of contraception
             throughout the study [and for at least 4 weeks after the last dose of study drug].

          -  Ability to take oral medication (dasatinib must be swallowed whole)

          -  Signed study-specific consent form prior to study entry

        Conditions for Patient Ineligibility

        Patients meeting any of the following exclusion criteria are not to be enrolled in the
        study:

          -  Evidence of distant metastases (M1).

          -  Prior radical prostatectomy, cryosurgery for prostate cancer, or bilateral orchiectomy
             for any reason

          -  PSA > 150

          -  Pathologically positive lymph nodes or nodes > 1.5 cm on imaging

          -  Major medical or psychiatric illness which, in the investigator's opinion, would
             prevent completion of treatment and would interfere with follow-up.

          -  Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a
             different cancer is allowable.

          -  Prior radiotherapy, including brachytherapy, to the region of the study cancer that
             would result in overlap of radiation therapy fields

          -  Medical History and Concurrent Diseases

          -  No malignancy [other than the one treated in this study] which required radiotherapy
             or systemic treatment within the past 5 years.

          -  Concurrent medical condition which may increase the risk of toxicity, including:

          -  Pleural or pericardial effusion of any grade

          -  Cardiac Symptoms; any of the following should be considered for exclusion:

          -  History of significant bleeding disorder unrelated to cancer, including:

          -  No history of pulmonary hypertension