Clinical trial NCT00651326 (phase 3, status: terminated)
Conditions: prostate cancer
ICD codes: C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5
Drugs: bicalutamide, buserelin, flutamide, goserelin, leuprolide acetate, docetaxel
SMILES: [H][C@]12SCC(C)=C(N1C(=O)[C@H]2NC(=O)[C@H](N)C1=CC=C(O)C=C1)C(O)=O, CC(C)C(=O)NC1=CC(=C(C=C1)[N+]([O-])=O)C(F)(F)F, CC(C)C[C@H](NC(=O)[C@@H](CC1=CNC2=CC=CC=C12)NC(=O)[C@H](CC1=CC=C(O)C=C1)NC(=O)[C@H](CO)NC(=O)[C@H](CC1=CNC2=C1C=CC=C2)NC(=O)[C@H](CC1=CNC=N1)NC(=O)[C@@H]1CCC(=O)N1)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N1CCC[C@H]1C(=O)NCC(N)=O, CC(C)C[C@H](NC(=O)[C@@H](COC(C)(C)C)NC(=O)[C@H](CC1=CC=C(O)C=C1)NC(=O)[C@H](CO)NC(=O)[C@H](CC1=CNC2=CC=CC=C12)NC(=O)[C@H](CC1=CN=CN1)NC(=O)[C@@H]1CCC(=O)N1)C(=O)N[C@@H](CCCN=C(N)N)C(=O)N1CCC[C@H]1C(=O)NNC(N)=O, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Reason stopped: 
    poor accrual
  
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed adenocarcinoma of the prostate

               -  Localized (N0, M0) disease

               -  No small cell or transitional cell carcinoma in the biopsy specimen

          -  Considered to be at high risk for recurrence based on the presence of at least one of
             the following adverse prognostic features:

               -  T stage ≥ 3a

               -  Gleason score ≥ 8

               -  Baseline prostate-specific antigen (PSA) > 20 ng/mL

          -  Deemed to be an appropriate candidate for chemotherapy, as assessed by a medical
             oncologist

          -  Negative pelvic and para-aortic lymph nodes on CT scan or MRI of the abdomen and
             pelvis

               -  Any lymph node appearing ≥ 1.5 cm on CT scan or MRI must be histologically
                  negative by either needle aspirate or lymph node dissection

          -  No metastases by chest x-ray and bone scan

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-1

          -  Absolute neutrophil count ≥ 1,500/mm³

          -  Platelet count ≥ 100,000/mm³

          -  Hemoglobin ≥ 10.0 g/dL

          -  AST and/or ALT ≤ 1.5 times upper limit of normal (ULN)

          -  Alkaline phosphatase ≤ 2.5 times ULN

          -  Total bilirubin normal

          -  Serum creatinine ≤ 1.5 times ULN

          -  Able (i.e., sufficiently fluent) and willing to complete the quality of life
             questionnaires in either English or French

          -  Fertile patients must use effective contraception

          -  No history of other malignancies, except adequately treated nonmelanoma skin cancer or
             other curatively treated solid tumor with no evidence of disease for > 5 years

          -  No serious non-malignant disease resulting in a life expectancy of < 10 years

          -  No known hypersensitivity to any study medications

          -  No existing peripheral neuropathy ≥ grade 2

          -  No bilateral hip replacement prostheses

          -  No contraindication to pelvic radiotherapy including, but not limited to, inflammatory
             bowel disease or severe bladder irritability

          -  No medical condition that would contraindicate the study treatment regimen, including
             severe respiratory insufficiency, uncontrolled diabetes, or severe hypertension

          -  No other serious illness or psychiatric or medical condition that would preclude
             management of the patient according to the study, including active uncontrolled
             infection or significant cardiac dysfunction

        PRIOR CONCURRENT THERAPY:

          -  Prior androgen suppression therapy allowed provided it was initiated no more than 4
             weeks prior to study entry

          -  At least 4 weeks since prior 5-alpha-reductase inhibitors (e.g., finasteride) for
             benign prostatic hypertrophy

          -  No prior cytotoxic anticancer therapy

          -  No prior chemotherapy for carcinoma of the prostate

          -  No prior surgical treatment for carcinoma of the prostate, except transurethral
             resection or bilateral orchiectomy

          -  No prior pelvic radiotherapy

          -  No concurrent nilutamide

          -  No other concurrent investigational drugs

          -  No other concurrent anticancer therapy (cytotoxic therapy, biologic/immunotherapy, or
             radiotherapy)