Bortezomib With or Without Hormone Therapy in Treating Patients With Relapsed Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Velcade; LH-RH Agonist; Androgen Receptor Antagonists
Intervention description: Part A: 1.3 mg/m2 administered on days 1, 4, 8 and 11 followed by 10 days rest. A second cycle will be given at the same schedule. Cycle 3 will include 3 weekly injections.
Part B: 1.3mg/m2 administered weekly for 3 weeks followed by 1 week break; given as a 3 month depo-injection; given orally daily for 3 months
Intervention MeSH terms: Bortezomib; Androgens; Androgen Receptor Antagonists
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: Male
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: adenocarcinoma of the prostate; recurrent prostate cancer

Summary:

      RATIONALE: Bortezomib may stop the growth of tumor cells by blocking some of the enzymes
      needed for cell growth. Androgens can cause the growth of prostate cancer cells. Drugs, such
      as goserelin, leuprolide, flutamide, or bicalutamide, may stop the adrenal glands from making
      androgens. Giving bortezomib with hormone therapy may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving bortezomib with or without hormone
      therapy works in treating patients with relapsed prostate cancer.
    

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