Prostate Cancer Clinical Trial
Bortezomib With or Without Hormone Therapy in Treating Patients With Relapsed 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
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There are 4 Locations for this study
Loma Linda California, 92354, United States
Charleston South Carolina, 29425, United States
Columbia South Carolina, 29210, United States
Spartanburg South Carolina, 29303, United States
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