Early Compared With Delayed Hormone Therapy in Treating Patients With Nonmetastatic Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT01819285|
Recruitment Status : Completed
First Posted : March 27, 2013
Last Update Posted : March 27, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Neoplasm, Prostate||Procedure: Immediate Orchiectomy or depot LHRH Procedure: Delayed Orchiectomy or depot LHRH||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||985 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||February 1990|
|Actual Primary Completion Date :||July 2004|
|Actual Study Completion Date :||September 2010|
Active Comparator: Immediate Endocrine Therapy
Immediate Endocrine Therapy. Orchiectomy or LHRH Agonist Therapy plus (initially) Antiandrogen Therapy. Buserelin (BSRL); Cyproterone acetate (Androcur) (CPTR), Cyproterone acetate (Androcur)(NSC-81430). Treatment initiated within 1 month of randomization.
Procedure: Immediate Orchiectomy or depot LHRH
Experimental: Delayed Endocrine Therapy
Orchiectomy or LHRH Therapy plus (initially) Antiandrogen Therapy. BSRL; CPTR. Treatment delayed until onset of symptoms.
Procedure: Delayed Orchiectomy or depot LHRH
- Overall survival [ Time Frame: 13 years from first patient in ]
- Overall symptom free survival time [ Time Frame: 13 years from first patient in ]
- Time until first evidence of distant progression [ Time Frame: 13 years from first patient in ]
- Prognostic importance of pretreatment laboratory data [ Time Frame: 13 years from first patient in ]prostate cancer mortality and overall mortality according to pretreatment laboratory data
- Prognosis of particular sub-groups [ Time Frame: 13 years from first patient in ]prostate cancer mortality and overall mortality according to particular sub-groups (following stratification factors): performance status (0 vs 1), the local tumor extent (T0-2 vs T3-4), nodal status (N0 vs N1-2), the choice of hormonal therapy.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01819285
|Study Chair:||Urs Studer, MD||University Hospital Inselspital, Berne|