Hormone Therapy in Treating Patients With Advanced Prostate Cancer

Study Overview
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Brief Summary
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RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using triptorelin may fight prostate cancer by reducing the production of androgens. PURPOSE: Randomized phase III trial to compare the effectiveness of long-term hormone therapy and triptorelin with no further treatment in treating patients who have advanced prostate cancer previously treated with radiation therapy and 6 months of androgen suppression.

Detailed Description
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OBJECTIVES: Determine the best hormonal scheme to be associated with pelvic radiotherapy in the curative management of prostatic carcinoma for hormonal treatment with regards to treatment outcome (overall survival, clinical disease free survival, local regional control), quality of life (treatment side effects, sexual function), and health economy (cost effectiveness ratio). OUTLINE: This is a randomized, multicenter study. Patients receive external radiation for 5 weeks, followed by a pelvic boost given for 2 weeks and a 6 month combined androgen blockage initiated at the onset of external irradiation. Flutamide (Eulexin) or bicalutamide (Casodex) may be used as the antiandrogens. Antiandrogen treatment starts 1 week before the first injection of triptorelin. Patients are then randomized to one of two treatment arms. Arm I: Patients receive no further treatment. Arm II: Patients receive antiandrogen for 2.5 years plus and LHRH analogue (triptorelin) administered every 3 months. Patients then continue the LHRH analogue alone for an additional 2.5 years in the absence of disease progression. Patients are followed every 6 months for 5 years and then annually thereafter. PROJECTED ACCRUAL: A total of 966 patients will be accrued over 5 years.

Official Title
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Long Term Adjuvant Hormonal Treatment With LHRH Analogue Versus No Further Treatment in Locally Advanced Prostatic Carcinoma Treated by External Irradiation and a Six Months Combined Androgen Blockade - A Phase III Study

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: bicalutamide
* Drug: flutamide
* Drug: triptorelin
* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate T1c-T2a-b, N1-2 or pN1-2 (after pelvic lymphadenectomy) T2c-T4, N0-2 Prior external radiotherapy for locally advanced prostatic carcinoma required Prior hormone therapy (6 months of combined androgen blockade) for locally advanced prostatic carcinoma required with PSA no greater than 150 ng/mL before administration No progressive disease after the 6 months of combined androgen blockage No stages T1c/T2a-b with a negative pelvic lymph nodes status that is assessed clinically or surgically No lymph node involvement to common iliac and/or periaortic lymph nodes (M1a) No external iliac lymph node metastasis more than 5 cm in greatest dimension (N3) No distant metastases PATIENT CHARACTERISTICS: Age: Any age Performance status: WHO 0-2 Life expectancy: At least 5 years Hematopoietic: Hemoglobin at least 10 g/dL WBC at least 2,000/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Not specified Renal: Not specified Other: No prior or concurrent cancers other than basal cell skin cancer No serious nonmalignant disease resulting in a life expectancy of less than 5 years PRIOR CONCURRENT THERAPY: Biologic therapy No prior biologic therapy for prostate cancer Chemotherapy No prior chemotherapy for prostate cancer Endocrine therapy See Disease Characteristics Radiotherapy See Disease Characteristics Surgery See Disease Characteristics
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: bicalutamide|nan|
|Drug: flutamide|nan|
|Drug: triptorelin|nan|
|Radiation: radiation therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adenocarcinoma of the prostate