PHASE III TRIAL OF ORCHIECTOMY/LHRH ANALOG + FLUTAMIDE + SURAMIN + HYDROCORTISONE VS ORCHIECTOMY/LHRH ANALOG + FLUTAMIDE IN PATIENTS WITH METASTATIC PROSTATE CANCER
OBJECTIVES: I. Compare time to progression and survival in patients with metastatic or
recurrent adenocarcinoma of the prostate treated with orchiectomy or LHRH analogue (i.e.
leuprolide or goserelin) plus flutamide with vs. without suramin and hydrocortisone. II.
Compare these two treatments with respect to qualitative and quantitative toxic effects.
III. Evaluate normalization of prostatic-specific antigen (PSA), duration of PSA response,
and the use of PSA as a surrogate marker of tumor response in these patients. IV. Compare
these two treatments with respect to quality of life and pain status.
OUTLINE: This is a randomized study. Patients are stratified by their choice of androgen
suppression technique and by participating institution. Within 3 days after randomization,
all patients receive daily flutamide. On day 4, patients undergo orchiectomy or begin
monthly LHRH analogue therapy with leuprolide or goserelin. Patients randomized to receive
suramin begin a 12-week course 8-25 days after orchiectomy/LHRH therapy. Hydrocortisone
replacement therapy begins concomitantly with suramin and continues for at least 3 months
after the completion of suramin treatment or until disease progression intervenes. Patients
are followed every 3 months.
PROJECTED ACCRUAL: A total of 800-1,000 patients will be entered within 3.25 to 4.25 years.
Allocation: Randomized, Primary Purpose: Treatment
George Wilding, MD
University of Wisconsin, Madison
United States: Federal Government
|Walter Reed Army Medical Center||Washington, District of Columbia 20307-5000|