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.

Condition	Treatment or Intervention	Phase
adenocarcinoma of the prostate	Drug: bicalutamide  Drug: flutamide  Drug: triptorelin  Procedure: androgen therapy  Procedure: antiandrogen therapy  Procedure: endocrine therapy  Procedure: hormone therapy  Procedure: radiation therapy	Phase III

Further Study Details: 

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.

Genders Eligible for Study:  Both

Criteria

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

Belgium
      Academisch Ziekenhuis der Vrije Universiteit Brussel, Brussels,  1090,  Belgium
      Institut Jules Bordet, Brussels (Bruxelles),  1000,  Belgium
      U.Z. Gasthuisberg, Leuven,  B-3000,  Belgium
      Universitair Ziekenhuis Antwerpen, Edegem,  B-2650,  Belgium
      Universitair Ziekenhuis Gent, Ghent,  B-9000,  Belgium
      Virga Jesse Hospital, Hasselt,  3500,  Belgium
Israel
      Rambam Medical Center, Haifa,  31096,  Israel
Malta
      St. Luke's Hospital and Medical School, Guardamangia,  MSD 07,  Malta
Netherlands
      Academisch Medisch Centrum, Amsterdam,  1105 AZ,  Netherlands
      Academisch Ziekenhuis Groningen, Groningen,  9700 RB,  Netherlands
      Academisch Ziekenhuis Maastricht, Maastricht,  6202 AZ,  Netherlands
      Groot Ziekengasthuis 's-Hertogenbosch, 's-Hertogenbosch,  5200 ME,  Netherlands
      Onze Lieve Vrouwe Gasthuis, Amsterdam,  1091 HA,  Netherlands
      St. Elisabeth Ziekenhuis, Tilburg,  5022 GC,  Netherlands
Russian Federation
      Medical Radiological Research Center, Obninsk,  Russian Federation
Turkey
      Marmara University Hospital, Istanbul,  81190,  Turkey
United Kingdom, England
      City General Hospital, Stoke on Trent,  England,  ST4 6QG,  United Kingdom

Study chairs or principal investigators

Michel Bolla, MD,  Study Chair,  CHR de Grenoble - La Tronche   
T.M. de Reijke, MD,  Study Chair,  Academisch Medisch Centrum   

Study ID Numbers:  CDR0000065616; EORTC-22961; EORTC-GU-22961
Record last reviewed:  April 2003
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003026
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08