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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
23
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
Loma Linda University Cancer Institute at Loma Linda University Medical Center
Loma Linda, California, United States
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States
South Carolina Oncology Associates, PA
Columbia, South Carolina, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States
Prostate-specific Antigen (PSA) Response
Time frame: 3 months after the start of treatment
Time to PSA Progression
PSA progression is defined as a PSA increase of 50% over the nadir CR or CR/PR value on three successive PSA measurements two months apart to a value of \>= 1.0 ng/ml.
Time frame: From on study until time of PSA progression for up to two years
Number of Patients Who Experienced an Adverse Event by CTCAE v. 2.0
Time frame: From start of treatment until end of study, up to 6 months
Disease-free Interval
This will only be analyzed if sample size warrants the analysis.
Time frame: 3 months after combined treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.