Early Compared With Delayed Hormone Therapy in Treating Patients With Nonmetastatic Prostate Cancer

European Organisation for Research and Treatment of Cancer (EORTC)

Status and phase: Completed; Phase 3

Conditions: Neoplasm, Prostate

Treatments: Procedure: Delayed Orchiectomy or depot LHRH; Procedure: Immediate Orchiectomy or depot LHRH

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT01819285

EORTC-30891

Details and patient eligibility

About

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.

Enrollment: 985 patients

Sex: Male

Ages: Under 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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985 participants in 2 patient groups

Immediate Endocrine Therapy

Active Comparator group

Description:

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.

Treatment:

Procedure: Immediate Orchiectomy or depot LHRH

Delayed Endocrine Therapy

Experimental group

Description:

Orchiectomy or LHRH Therapy plus (initially) Antiandrogen Therapy. BSRL; CPTR. Treatment delayed until onset of symptoms.

Treatment:

Procedure: Delayed Orchiectomy or depot LHRH