Clinical trial NCT00002633 (phase 3, status: completed)
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, nilutamide
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, CC1(C)NC(=O)N(C1=O)C1=CC(=C(C=C1)[N+]([O-])=O)C(F)(F)F
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically proven locally advanced adenocarcinoma of the prostate, defined as 1 of
             the following:

               -  T3-4, N0 or NX, M0

               -  T2, PSA greater than 40 µg/L

               -  T2, PSA greater than 20 µg/L AND Gleason score at least 8

          -  Diagnosis made within the past 6 months

          -  Gleason score and PSA known

          -  Pelvic lymph nodes must be clinically negative

               -  Lymph nodes no more than 1.5 cm in greatest diameter by CT scan or MRI of the
                  pelvis

               -  Negative needle aspirate required for any lymph node more than 1.5 cm

               -  If a lymph node dissection was performed, it must be histologically negative

          -  No small cell or transitional cell carcinoma by biopsy

          -  No bony metastases by bone scan

        PATIENT CHARACTERISTICS:

        Age:

          -  Under 80

        Performance status:

          -  ECOG 0-2

        Life expectancy:

          -  At least 5 years excluding malignancy

        Hematopoietic:

          -  Hemoglobin at least 10.0 g/dL

          -  WBC at least 2,000/mm^3

          -  Platelet count at least 100,000/mm^3

        Hepatic:

          -  Bilirubin less than 2 times upper limit of normal (ULN)

          -  SGOT and SGPT less than 2 times ULN

          -  Alkaline phosphatase less than 2 times ULN

          -  No history of chronic liver disease

        Renal:

          -  Creatinine less than 2 times ULN

        Other:

          -  No contraindication to wide-field pelvic irradiation (e.g., inflammatory bowel disease
             or severe bladder irritability)

          -  No other malignancy within the past 5 years except nonmelanoma skin cancer

          -  Fertile patients must use effective contraception

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  Not specified

        Chemotherapy:

          -  Not specified

        Endocrine therapy:

          -  Prior hormonal therapy within the past 12 weeks allowed provided the following
             conditions are met:

               -  Negative bone scan before beginning any hormonal therapy

               -  Extracapsular extension remains palpable on rectal re-exam

               -  Baseline PSA known before beginning any hormonal therapy

          -  At least 4-6 weeks since prior 5-alpha-reductase inhibitor (e.g., finasteride) for
             benign prostatic hypertrophy

        Radiotherapy:

          -  No prior pelvic irradiation

        Surgery:

          -  No prior radical prostatectomy

          -  Prior transurethral resection of the prostate allowed

        Other:

          -  No prior cytotoxic anticancer therapy

          -  No other prior treatment for prostate cancer

          -  No other concurrent anticancer therapy unless documented disease progression