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
- 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,
- 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.
- 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.