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
Immediate Orchiectomy or depot LHRH
+ Delayed Orchiectomy or depot LHRH
Urogenital Diseases+7
+ Genital Diseases
+ Genital Diseases, Male
Treatment Study
Summary
Study start date: February 1, 1990
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.985 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Male
Biological sex of participants that are eligible to enroll.Until 80 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: Histologically or cytologically proven, newly diagnosed asymptomatic (with the exception of voiding disturbances) carcinoma of the prostate T0-4 N0-2 M0 which is not suitable for local treatment with curative intent (radical prostatectomy, radiation therapy). All T stages are acceptable (UICC 1982). The stage is determined by rectal palpation. Patients with regional lymph node metastases smaller than 5 cm (N0-2), determined either by CT or ultrasonography, preferable with cytologic confirmation. Life expectancy of at least six months. WHO performance status score 0-1. Informed consent. Patients must be prepared to undergo an orchiectomy or continuous treatment with a depot LHRH analogue. Continuous follow-up until death if possible. Exclusion Criteria: Other malignancies diagnosed during the last 10 years, apart from treated basal cell carcinoma of the skin. Prostate cancer known for longer than one month before entering the study. Pain caused by the prostate cancer or its metastases. Any previous treatment for prostate cancer (radical prostatectomy, radiation therapy, endocrine treatment, etc.) Note: TUR-P for voiding disturbances is allowed at any time and is not an exclusion criterion. Patients with ureteric obstruction caused by local infiltration of prostatic cancer and other evidence of locally advanced disease which could cause fatal complications if untreated (e.g. rectal stenosis, thrombosis of pelvic veins). Patients with palpable or juxtaregional lymph node metastasis (paraaortic, supraclavicular, inguinal, N3-4). Patients with evidence of distant metastases (bone, lung, liver). Age over 80 years. Performance status WHO score 2, 3 and 4 (any reason). Patient who refuses orchiectomy or longterm subcutaneous implants of LHRH analogue in two monthly intervals. Expected difficulties with follow-up for any reason.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives