VELCADE® (Bortezomib) for Injection Therapy for Early Relapsed Prostate Cancer
- Determine the prostate-specific antigen (PSA) relapse after an observed rise in
testosterone after combination treatment with hormone blockade and bortezomib.
- Determine the safety of this drug in combination with combined androgen blockade
therapy in these patients.
- Determine the disease-free interval in patients treated with this regimen.
- Determine time to tsetosterone rise in patients treated wtih this regimen.
OUTLINE: This is an open-label, multicenter study.
Patients receive androgen blockade therapy comprising a 3-month subcutaneous injection of
goserelin OR leuprolide OR other FDA-approved method of primary androgen suppression AND
oral flutamide or bicalutamide once daily for 3 months. Patients also receive bortezomib IV
over 3-5 seconds on days 1, 8, and 15. Treatment with bortezomib repeats every 28 days for 3
courses. Patients achieving a CR discontinue treatment and are observed for PSA or
metastatic disease recurrence. Patients with a PR or stable disease receive additional
combined androgen blockade therapy and 3 additional courses of bortezomib as above. Patients
with progressive disease are removed from the study.
Patients are followed every 3 months for up to 5 years.
PROJECTED ACCRUAL: A total of 21-42 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Prostate-specific antigen (PSA) response as measured by complete or partial response, stable or progressive disease 3 months after initial treatment
Andrew S. Kraft, MD
Medical University of South Carolina
United States: Food and Drug Administration
|Loma Linda University Cancer Institute at Loma Linda University Medical Center||Loma Linda, California 92354|
|Hollings Cancer Center at Medical University of South Carolina||Charleston, South Carolina 29425|
|Gibbs Regional Cancer Center at Spartanburg Regional Medical Center||Spartanburg, South Carolina 29303|
|South Carolina Oncology Associates, PA||Columbia, South Carolina 29210|