Clinical trial NCT02560051 (phase 2, status: terminated)
Conditions: prostatic neoplasms
ICD codes: B38.81, N42.31, Z87.430, N40.0, N40.1
Drugs: doxorubicin, ketoconazole, docetaxel, estramustine, degarelix
SMILES: COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O, OC(CN1C=NC=N1)(CN1C=NC=N1)C1=C(F)C=C(F)C=C1, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, [H][C@@]12CC[C@H](O)[C@@]1(C)CC[C@]1([H])C3=CC=C(OC(=O)N(CCCl)CCCl)C=C3CC[C@@]21[H], CC(C)C[C@H](NC(=O)[C@@H](CC1=CC=C(NC(N)=O)C=C1)NC(=O)[C@H](CC1=CC=C(NC(=O)[C@@H]2CC(=O)NC(=O)N2)C=C1)NC(=O)[C@H](CO)NC(=O)[C@@H](CC1=CC=CN=C1)NC(=O)[C@@H](CC1=CC=C(Cl)C=C1)NC(=O)[C@@H](CC1=CC=C2C=CC=CC2=C1)NC(C)=O)C(=O)N[C@@H](CCCCNC(C)C)C(=O)N1CCC[C@H]1C(=O)N[C@H](C)C(N)=O
Reason stopped: 
    slow accrual; resource re-allocation
  
Eligibility criteria:

        Inclusion criteria:

          -  Pathologic proof of adenocarcinoma of the prostate.

          -  Patients must belong to one of the following subsets:

          -  Prior local therapy

          -  Patients with Prostate Specific Antigen (PSA) recurrence following prostatectomy or
             radiation therapy who have no radiographic involvement. PSA doubling time ≤6 months.

          -  Nodal involvement only.

          -  Low volume bone disease: ≤3 metastases.

          -  Nodal involvement with associated bone involvement.

          -  High volume bone-visceral disease: Patients with >3 metastatic bone sites or visceral
             metastases.

          -  No prior definitive local therapy

          -  Tumors felt to be unresectable, not candidates for radiation therapy, and PSA elevated
             with biopsy-proven disease.

          -  Metastatic disease at presentation.

          -  Patients may have started ADT within 3 months of study entry.

          -  No previous cytotoxic therapy is allowed, including systemic irradiation with
             strontium-89, samarium, or radium-223.

          -  Previous definitive radiotherapy to one metastatic site is acceptable, provided that
             unirradiated sites remain. At least 8 weeks must have elapsed since radiation therapy
             to the pelvis. Patients having limited irradiation of a metastatic site are eligible 4
             weeks following radiation.

          -  Patients may have had previous exposure to ADT if it was given for ≤6 months to
             "downstage" the primary and provided that such therapy was completed at least 12
             months prior to entry into this study with a return of serum testosterone to ≥200
             ng/dL.

          -  Patients must be free of serious comorbidity and have a life expectancy of ≥3 years.

          -  Patients must have adequate physiologic reserves as evidenced by:

          -  Eastern Cooperative Oncology Group (ECOG) status of ≤2.

          -  Patients must have adequate bone marrow function: Platelets ≥100,000 cells/mm3,
             Hemoglobin ≥9.0 g/dL, and Absolute Neutrophil Count (ANC) ≥1,500 cells/mm3.

          -  Patients must have adequate renal function: creatinine ≤2 × upper limit of normal
             (ULN).

          -  Patients must have adequate liver function: Aspartate aminotransferase (AST) / Alanine
             transaminase (ALT) ≤2.5 × ULN; alkaline phosphatase <2.5 × ULN, unless bone metastasis
             is present in the absence of liver metastasis; and bilirubin < ULN or 1.5 mg/dl.

          -  No evidence of active ischemia on electrocardiogram (ECG) and documentation of
             ejection fraction (EF) ≥50%.

        Exclusion criteria:

          -  Patients must not have a second malignancy unless there is confidence of previous
             curative therapy.

          -  Patients with a recent history of transient ischemic attack (TIA) (within 6 months),
             who are requiring regular antianginal therapy, or who are having claudication
             sufficient to limit activity are not eligible. Patients with a previous history of
             deep venous thrombosis or pulmonary embolism (within 12 months) are not eligible

          -  Patients must not have a serious intercurrent medical or psychiatric illness,
             including serious active infection.

          -  Patients must not have sensory neuropathy > grade 1.