Bortezomib With or Without Hormone Therapy in Treating Patients With Relapsed Prostate Cancer

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