Clinical trial NCT00528866 (phase 2, status: completed)
Conditions: prostate cancer
ICD codes: C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5
Drugs: bicalutamide, docetaxel, flutamide, lhrh agonist
SMILES: [H][C@]12SCC(C)=C(N1C(=O)[C@H]2NC(=O)[C@H](N)C1=CC=C(O)C=C1)C(O)=O, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, 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
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Pathologically proven adenocarcinoma of the prostate gland meeting one of the
             following criteria:

               -  Gleason ≥ 7and post-operative PSA nadir > 0.2 ng/ml with any pathologic tumor
                  (pT) classification

               -  Gleason ≥ 8, post-operative PSA nadir ≤ 0.2 ng/ml and ≥ pT3a classification

          -  Must have undergone radical prostatectomy within the past year

          -  PSA must be obtained within 6 weeks (42 days) prior to study registration

          -  No lymph node or distant metastases (N0, M0), based upon the following minimum
             diagnostic workup:

               -  History and physical examination within 8 weeks prior to study registration

               -  Bone scan and CT or MRI of the pelvis and no evidence of osseous metastases on
                  bone scan within 16 weeks prior to study registration

          -  No pelvic lymph nodes > 1.5 cm in greatest dimension on CT scan or MRI of the pelvis
             within 16 weeks prior to study registration, unless the enlarged lymph node is
             biopsied and negative

        PATIENT CHARACTERISTICS:

          -  Zubrod performance status 0-1

          -  Absolute neutrophil count (ANC) ≥ 2,000/mm³

          -  Platelet count ≥ 100,000/mm³

          -  Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention to achieve hemoglobin ≥ 8.0
             g/dL is acceptable)

          -  Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 times upper
             limit of normal (ULN)

          -  Alkaline phosphatase ≤ 2.5 times ULN

          -  Total bilirubin ≤ 1.2 times ULN

          -  No other invasive malignancy within the past 3 years except non-melanomatous skin
             cancer

          -  No active, severe co-morbidity, including any of the following:

               -  Unstable angina and/or congestive heart failure requiring hospitalization within
                  the past 6 months

               -  Transmural myocardial infarction within the past 6 months

               -  Acute bacterial or fungal infection requiring intravenous antibiotics

               -  Chronic obstructive pulmonary disease exacerbation or other respiratory illness
                  requiring hospitalization or precluding study therapy

               -  AIDS

                    -  HIV testing is not required for study entry

          -  No prior allergic reaction to the study drug(s)

        PRIOR CONCURRENT THERAPY:

          -  No prior systemic chemotherapy for prostate cancer

          -  More than 3 years since prior chemotherapy for a different cancer

          -  No prior androgen deprivation for treatment of prostate cancer

               -  Prior use of hormonal agents, such as finasteride or dutasteride, for treatment
                  of benign prostatic hypertrophy is allowed

          -  No prior radiotherapy to the region of the prostate that would result in overlap of
             radiotherapy fields