Clinical trial NCT00103376 (phase 2, status: terminated)
Conditions: prostate cancer
ICD codes: C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5
Drugs: velcade, lh-rh agonist, androgen receptor antagonists
SMILES: CN1C(CCCC(O)=O)=NC2=CC(=CC=C12)N(CCCl)CCCl
Reason stopped: 
    low accrual
  
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed adenocarcinoma of the prostate

          -  Relapsed disease after definitive local therapy, as documented only by a rise in
             prostate-specific antigen (PSA)

               -  Experienced PSA relapse after definitive local therapy

               -  Rising PSA (≥ 1.0 ng/mL after nadir < 1.0 ng/mL)

                    -  PSA increase of ≥ 0.3 ng/mL (increase occurred between 2 separate
                       measurements taken ≥ 4 weeks apart)

               -  The first of these two PSA values must rise above a previously recorded
                  post-therapy nadir value

          -  Ineligible for curative therapy

          -  No clinical evidence of local recurrence (i.e., palpable induration or mass in the
             prostatic fossa) other than PSA elevation

          -  No evidence of palpable disease in the prostatic bed

          -  No metastatic disease (M0)

               -  No non-nodal (> N1) metastasis

               -  No evidence of osseous metastasis on bone scan within the past 28 days

        PATIENT CHARACTERISTICS:

        Age

          -  Over 18

        Performance status

          -  ECOG 0-1

        Life expectancy

          -  At least 1 year

        Hematopoietic

          -  Platelet count ≥ 30,000/mm^3

          -  Absolute neutrophil count ≥ 1,000/mm^3

        Hepatic

          -  No known hepatitis B or C positivity

        Renal

          -  Creatinine clearance ≥ 30 mL/min

        Immunologic

          -  No known human T-cell lymphotropic virus positivity

          -  No hypersensitivity to bortezomib, boron, or mannitol

          -  No known HIV 1 or 2 positivity

          -  No active, ongoing bacterial, viral, or fungal infection

        Other

          -  Fertile patients must use effective contraception

          -  No peripheral neuropathy ≥ grade 2

          -  No other disease, condition, or social or geographic constraint that would preclude
             study participation

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

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  Not specified

        Chemotherapy

          -  No concurrent chemotherapy

        Endocrine therapy

          -  See Disease Characteristics

          -  At least 6 months since prior hormonal therapy combined with radiation therapy as
             definitive therapy

          -  Neoadjuvant hormonal therapy prior to definitive therapy (e.g., surgery, radiation
             therapy, brachytherapy, or cryoablation) allowed

          -  No other concurrent hormonal therapy

        Radiotherapy

          -  See Disease Characteristics

          -  More than 12 months since prior radioactive seed therapy

          -  No concurrent radiotherapy

        Surgery

          -  See Disease Characteristics

          -  More than 4 weeks since prior surgery

          -  No concurrent surgery

        Other

          -  No concurrent second-line herbal preparations, including PC-SPES

          -  No other concurrent investigational agents