Clinical trial NCT02494713 (phase 2, status: terminated)
Conditions: prostate cancer
ICD codes: C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5
Drugs: degarelix, doxorubicin, ketoconazole, docetaxel, estramustine
SMILES: 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, 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]
Reason stopped: 
    slow enrollment; resource re-allocation
  
Eligibility criteria:

        Inclusion Criteria:

          -  Pathologic proof of prostatic adenocarcinoma without evidence of regional and/or
             distant metastasis, clinical stage T1c or T2a with high grade disease (Gleason 8-10)
             on initial biopsy, clinical stage T2b-T2c with Gleason grade 7 (4+3), or clinical
             stage T3. No neuroendocrine differentiation or small cell features.

          -  Recent (<6 weeks prior to study entry) negative bone scan and CT of the chest and
             abdomen.

          -  Appropriate surgical candidate for radical prostatectomy and a performance status of
             <2 (ECOG scale).

          -  Adequate bone marrow function as defined as an absolute peripheral granulocyte count
             >1500 and platelet count >100,000.

          -  Adequate hepatic function per the following criteria:

               -  Albumin ≥2.8 g/dL

               -  AST and ALT ≤5 x ULN

               -  Total bilirubin <2 mg/dL

          -  Adequate renal function per the following criteria:

             o Serum creatinine ≤1.5 x ULN

          -  Normal coagulation profile (INR ≤ 1.5, aPTT ≤ 1.5 x ULN for the lab) and no history of
             substantial non-iatrogenic bleeding diatheses. Use of anticoagulants is limited to
             local use only (for control of central line patency).

          -  Age ≥ 18 years

          -  Written informed consent to participate in this study.

        Exclusion Criteria:

          -  Prostatic adenocarcinoma with neuroendocrine differentiation or small cell features

          -  Surgical resection or major surgery within 4 weeks or stereotactic biopsy within 1
             week of first ADT and chemotherapy treatment

          -  Previous or current hormonal treatment, chemotherapy, radiation therapy,
             immunotherapy, or investigational study drug.

          -  Unable to tolerate multiparametric MRI or is contraindicated.

          -  Patients not appropriate surgical candidates for radical prostatectomy based on the
             evaluation of coexistent medical diseases and competing causes of death.

          -  Patients with uncontrolled cardiac, hepatic, renal, or neurologic/psychiatric
             disorder.

          -  Severe gastrointestinal bleeding within 12 weeks of treatment with ADT and
             chemotherapy

          -  Patients who are HIV positive or have chronic hepatitis B or C infections.

          -  Congestive heart failure New York Heart Association (NYHA) class 3 or 4, or history of
             congestive heart failure New York Heart Association (NYHA) class 3 or 4, unless a 2D
             echocardiogram or multi-gated acquisition scan (MUGA) performed within 3 months of
             enrollment demonstrates a left ventricular ejection fraction >45%.

          -  Sensory neuropathy grade >1.

          -  History of another malignancy within the previous 5 years other than curatively
             treated non-melanoma skin cancer.

          -  Use of herbal products that may decrease PSA levels (e.g., saw palmetto) or systemic
             corticosteroids greater than the equivalent of 10 mg of prednisone per day within 4
             weeks of enrollment.

          -  Any other condition, including concurrent medical condition, social circumstance or
             drug dependency, which in the opinion of the investigator could compromise patient
             safety and/or compliance with study requirements