RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether standard radiation therapy is more effective than high-dose radiation therapy in treating patients with prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of standard radiation therapy with that of high-dose radiation therapy in treating patients with stage II or stage III prostate cancer.

Condition	Treatment or Intervention	Phase
stage II prostate cancer stage III prostate cancer	Procedure: radiation therapy  Procedure: hormone therapy  Procedure: endocrine therapy  Procedure: releasing factor agonist therapy  Drug: luteinizing hormone-releasing factor	Phase III

Further Study Details: 

OBJECTIVES: I. Compare local tumor control in patients with stage II or III prostate cancer treated with neoadjuvant androgen deprivation therapy with standard vs high-dose conformal radiotherapy. II. Compare the incidence of biochemical failure (prostate-specific antigen (PSA) greater than 2 ng/mL at 6 or more months after initiation of radiotherapy and PSA rising from nadir level by at least 50%), development of metastases, and survival in patients treated with these regimens. III. Compare the acute and late radiation-induced side effects of these regimens in this patient population. IV. Compare aspects of quality of life, health economics, models of normal tissue, and tumor control in patients treated with these regimens.

PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prostate-specific antigen, T stage, and Gleason score. Patients are randomized to one of two treatment arms. All patients receive neoadjuvant androgen deprivation with luteinizing hormone-releasing hormone agonists every 4 weeks beginning 3-6 months before initiation of radiotherapy and continuing until completion of radiotherapy. Arm I: Patients undergo standard conformal radiotherapy for 6.5 weeks. Arm II: Patients undergo high-dose conformal radiotherapy for 7.5 weeks. Quality of life is assessed at baseline, every 6 months for 2 years, and then annually thereafter. Patients are followed every 6 months for 2 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 800 patients will be accrued for this study.

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Histologically confirmed prostate cancer

• T1b-T3a, N0, M0 (stage II or III)

Prostate-specific antigen at least 50 ng/mL

--Prior/Concurrent Therapy--

Biologic therapy: Not specified

Chemotherapy: Not specified

Endocrine therapy: No prior androgen deprivation therapy

Radiotherapy: No prior pelvic radiotherapy

Surgery: No prior radical prostatectomy

--Patient Characteristics--

Age: Not specified

Performance status: WHO 0-1

Life expectancy: Not specified

Hematopoietic:

• WBC greater than 4,000/mm3
• Platelet count greater than 100,000/mm3
• Hemoglobin greater than 11 g/dL

Hepatic: Not specified

Renal: Not specified

Other:

• No significant past medical history that would preclude radical radiotherapy
• No condition that would preclude standard radiotherapy
• No hip prosthesis

South Africa
      Groote Schuur Hospital, Cape Town, Cape Town,  7925,  South Africa
United Kingdom
      Royal Preston Hospital, Preston,  PR2 9HT,  United Kingdom
United Kingdom, England
      Bristol Haematology and Oncology Centre, Bristol,  England,  BS2 8ED,  United Kingdom
      Bristol Royal Hospital for Children, Bristol,  England,  BS2 8BJ,  United Kingdom
      Christie Hospital N.H.S. Trust, Manchester,  England,  M20 4BX,  United Kingdom
      Clatterbridge Centre for Oncology NHS Trust, MERSEYSIDE,  England,  L63 4JY,  United Kingdom
      Cookridge Hospital, Leeds,  England,  LS16 6QB,  United Kingdom
      Derbyshire Royal Infirmary, Derby,  England,  DE1 2QY,  United Kingdom
      Middlesex Hospital- Meyerstein Institute, London,  England,  WIT 3AA,  United Kingdom
      Mount Vernon Hospital, Northwood,  England,  HA6 2RN,  United Kingdom
      Newcastle General Hospital, Newcastle upon Tyne,  England,  NE4 6BE,  United Kingdom
      Norfolk & Norwich Hospital, Norwich,  England,  NR1 3SR,  United Kingdom
      Oxford Radcliffe Hospital, Oxford,  England,  0X3 9DU,  United Kingdom
      Royal Marsden Hospital, Sutton,  England,  SM2 5PT,  United Kingdom
      Southend NHS Trust Hospital, Westcliff-On-Sea,  England,  United Kingdom
      University Hospitals of Leicester, Leicester,  England,  LE1 5WW,  United Kingdom
      University of Birmingham, Birmingham,  England,  B15 2TT,  United Kingdom
United Kingdom, Scotland
      Beatson Oncology Centre, Glasgow,  Scotland,  G11 6NT,  United Kingdom
      Royal Hospital for Sick Children, Edinburgh,  Scotland,  United Kingdom

Study chairs or principal investigators

David P. Dearnaley,  Study Chair,  Medical Research Council   

Study ID Numbers:  CDR0000066222; MRC-RT01; EU-98005
Record last reviewed:  April 2003
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003290
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08