Clinical trial NCT00003653 (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, cyproterone acetate, 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, [H][C@@]12C[C@]1([H])[C@@]1(C)C(=CC2=O)C(Cl)=C[C@@]2([H])[C@]3([H])CC[C@](OC(C)=O)(C(C)=O)[C@@]3(C)CC[C@]12[H], 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 or cytologically proven adenocarcinoma of the prostate prior to the
             initiation of radiotherapy

          -  Prior pelvic radiotherapy for prostate cancer, either post-radical prostatectomy or as
             primary management

               -  More than 30 months since prior brachytherapy with curative intent

          -  Prostate-specific antigen must be rising and greater than 3 ng/mL and higher than the
             lowest level recorded previously since the end of radiotherapy (i.e., higher than the
             post-radiotherapy nadir)

          -  Total testosterone greater than 5 nmol/L

          -  No definite evidence of metastatic disease

               -  Chest x-ray and bone scan negative for metastases

               -  Radiological changes compatible with nonmalignant diseases allowed

          -  Clinical evidence of local disease allowed

        PATIENT CHARACTERISTICS:

        Age:

          -  16 and over (18 and over for participating centers in the United Kingdom)

        Performance status:

          -  ECOG 0-1

        Life expectancy:

          -  More than 5 years

        Hematopoietic:

          -  Not specified

        Hepatic:

          -  Bilirubin no greater than 1.5 times upper limit of normal (ULN)

          -  AST/ALT no greater than 1.5 times ULN

          -  LDH no greater than 1.5 times ULN

          -  No chronic liver disease

        Renal:

          -  Creatinine no greater than 1.5 times ULN

        Other:

          -  Sufficiently fluent and willing to complete the quality of life questionnaire in
             either English or French

          -  Fertile patients must use effective contraception

          -  No other malignancy within the past 5 years except curatively treated basal or
             squamous cell skin cancer or superficial bladder cancer

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  No prior or concurrent biologic therapy

        Chemotherapy:

          -  No prior or concurrent chemotherapy

        Endocrine therapy:

          -  Prior hormonal therapy administered prior to, during, or immediately after radical
             radiotherapy or prostatectomy allowed provided duration was no longer than 12 months

               -  At least 12 months since prior hormonal therapy

        Radiotherapy:

          -  See Disease Characteristics

          -  At least 12 months since prior radiotherapy

          -  No concurrent palliative radiotherapy

        Surgery:

          -  See Disease Characteristics

          -  See Endocrine therapy

        Other:

          -  No concurrent bisphosphonates