Neoplasm, Prostate Clinical Trial
Official title:
Phase III Comparison of Early vs Delayed Endocrine Manipulation (Orchiectomy or LHRH Agonist Therapy) in Previously Untreated Patients With Nonmetastatic Asymptomatic Carcinoma of the Prostate
Objectives
I. Compare, in a randomized Phase III multi-institutional setting, symptom-free survival
time of patients with asymptomatic carcinoma of the prostate (T0-4, N0-2, M0) not suited for
local curative treatment who are randomly assigned to immediate vs. delayed endocrine
intervention (orchiectomy or luteinizing hormone releasing hormone (LHRH) agonist therapy).
II. Compare the overall survival of these two groups of patients.
III. Compare the time to first evidence of distant progression (N4 or M1) of these two
treatment groups.
IV. Evaluate the prognostic significance of pretreatment laboratory data and monitor these
parameters following endocrine therapy.
V. Study the prognosis of various sub-groups of patients stratified according to performance
status, local tumor extent, nodal status, and choice of endocrine treatment.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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