Clinical trial NCT02758132 (phase 2, status: terminated)
Conditions: prostate cancer
ICD codes: C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5
Drugs: enzalutamide, abiraterone, prednisone
SMILES: CNC(=O)C1=C(F)C=C(C=C1)N1C(=S)N(C(=O)C1(C)C)C1=CC=C(C#N)C(=C1)C(F)(F)F, [H][C@@]12CC=C(C3=CC=CN=C3)[C@@]1(C)CC[C@@]1([H])[C@@]2([H])CC=C2C[C@@H](O)CC[C@]12C, [H][C@@]12CC=C(C3=CC=CN=C3)[C@@]1(C)CC[C@@]1([H])[C@@]2([H])CC=C2C[C@@H](O)CC[C@]12C
Reason stopped: 
    low accruals
  
Eligibility criteria:

        Inclusion Criteria:

          -  Histologic proof of adenocarcinoma of the prostate with clinical evidence of
             metastatic disease to the bone.

          -  Castrate resistant progression of prostate carcinoma, as shown by:

               -  Serum testosterone level <50 ng/dL or prior bilateral orchiectomy. Treatment to
                  maintain castrate levels of testosterone should continue, and

                    -  Either symptomatic progression, or, if patient is asymptomatic then a rising
                       serum PSA in two occasions at least 1 week apart, with minimum pre-treatment
                       serum PSA of 5 ng/dL.

          -  Patients with nodal disease are eligible.

          -  Bi-dimensionally measurable disease within the bone.

          -  Life expectancy of at least 12 weeks.

          -  ECOG Performance status < 2

          -  Adequate:

               -  Bone marrow function; absolute neutrophil count > 1,500 mm3, platelet count of >
                  100,000 mm3 and hemoglobin > 9.0 gm/dl.

               -  Hepatic function; SGOT/SGPT and conjugated bilirubin less than twice the upper
                  limit of normal.

               -  Renal function; serum creatinine ≤ 2 mg/dL (or, if creatinine > 2 mg/dL, then a
                  creatinine clearance of at least 35 ml/min (measured or estimated by the Cockroft
                  formula:

        CLcr = [(140-age) x wt (kg)]/[72 x serum creatinine (mg/dL)].

          -  No evidence of coagulopathy as indicated by PT < 1.5X upper limit of normal.

          -  Serum calcium (corrected) from 8 to11.5 mg/dL (2 to 2.9 mmol/L) - Patients must sign
             an informed consent indicating that they are aware of the investigational nature of
             the study.

        Exclusion Criteria:

          -  Patients with variant histologies (e.g., ductal or small cell carcinoma).

          -  Patients with visceral disease are ineligible.

          -  Patients who have had prior Sipuleucel-T, docetaxel, cabazitaxel, abiraterone or
             enzalutamide as a single agent, or in combination therapy.

          -  Concurrent cancer chemotherapy, radiotherapy or surgery.

          -  Concurrent serious infection.

          -  Life threatening illness (e.g., congestive heart failure, uncontrolled angina or
             myocardial infarction in the prior six months).

          -  Hypertension uncontrolled by medication.

          -  Patients who are known to require invasive dental procedures.

          -  No known or suspected brain metastases (NOTE: patients with treated epidural disease
             are allowed)

          -  Administration of any investigational drug within 28 days prior to receipt of
             denosumab.

          -  Age ≤ 18 years of age