RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using triptorelin and flutamide may fight cancer by reducing the production of androgens. It is not yet known whether giving hormone therapy for 4 months is more effective than giving therapy for 8 months prior to radiation therapy for prostate cancer. PURPOSE: Randomized phase III trial to study the effectiveness of combination hormone therapy for 4 or 8 months followed by radiation therapy in treating patients with prostate cancer.

Condition	Treatment or Intervention	Phase
stage II prostate cancer stage III prostate cancer stage IV prostate cancer stage I prostate cancer adenocarcinoma of the prostate	Procedure: radiation therapy  Procedure: hormone therapy  Procedure: endocrine therapy  Procedure: antiandrogen therapy  Procedure: releasing factor agonist therapy  Drug: flutamide  Drug: triptorelin	Phase III

Further Study Details: 

OBJECTIVES: I. Compare the efficacy of 4 months vs 8 months of luteinizing hormone-releasing hormone (LHRH) agonist therapy combined with antiandrogen therapy prior to radiotherapy, in terms of disease-free survival and overall survival, in patients with stage I-IV localized invasive prostate cancer.

PROTOCOL OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms. All patients receive triptorelin IM once a month and oral flutamide three times daily with meals. Patients randomized to arm I receive this therapy regimen for 4 months. Patients randomized to arm II receive this therapy regimen for 8 months. All patients then undergo radiotherapy 5 days a week for 7 weeks within 2 months of the last injection of triptorelin and within 1 month of the last oral flutamide tablet. Patients are followed every 3 months after radiotherapy.

PROJECTED ACCRUAL: A total of 276 patients (138 per treatment arm) will be accrued for this study.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically confirmed invasive adenocarcinoma of the prostate: Stage I or II (PSA greater than 20 or Gleason score at least 7) OR Stage III or IV (any PSA, any Gleason)
• Histologically confirmed benign nodal status
• No distant metastases

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: Not specified
• Endocrine therapy: No prior or other concurrent hormonal therapy
• Radiotherapy: Not specified
• Surgery: No prior treatment other than transurethral prostatectomy; No prior orchiectomy

--Patient Characteristics--

• Age: 18 and over
• Performance status: Karnofsky 60-100%
• Life expectancy: Not specified
• Hematopoietic: Not specified
• Hepatic: Not specified
• Renal: Not specified
• Other: No other prior malignancy except nonmelanoma skin cancer; No other uncontrolled illness that would prevent compliance

Ireland
      Adelaide and Meath Hospital, Dublin,  8,  Ireland
      Beaumont Hospital, Dublin,  9,  Ireland
      Bon Secours Hospital, Galway,  Ireland
      Cork University Hospital, Cork,  Ireland
      Galway University Hospital, Galway,  Ireland
      Letterkenny Hospital, Donnegal,  Ireland
      Mater Misericordiae Hospital, Dublin,  7,  Ireland
      Regional Hospital - Limerick, Limerick,  Ireland
      Saint Luke's Hospital, Dublin,  6,  Ireland
      Sligo General, Sligo,  Ireland
      St. Vincent's Hospital, Dublin,  4,  Ireland
United Kingdom, Northern Ireland
      Belfast City Hospital Trust Incorporating Belvoir Park Hospital, Belfast,  Northern Ireland,  BT8 8JR,  United Kingdom

Study chairs or principal investigators

John Gerard Armstrong,  Study Chair,  St. Luke's Hospital   

Study ID Numbers:  CDR0000066849; ICORG-97-01; EU-98060
Record last reviewed:  December 2003
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003734
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08