RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells and may be an effective treatment for prostate cancer.

PURPOSE: Randomized phase III trial to compare radiation therapy with no further treatment in treating patients with stage III prostate cancer following radical prostatectomy.

Condition	Treatment or Intervention	Phase
adenocarcinoma of the prostate stage I prostate cancer stage II prostate cancer stage III prostate cancer	Procedure: low-LET photon therapy  Procedure: radiation therapy	Phase III

Further Study Details: 

OBJECTIVES:

• Compare local recurrence rates, acute and late morbidity, overall survival, disease-free survival, and cancer-related survival of patients with pT3 pN0 adenocarcinoma of the prostate randomized following radical prostatectomy to postoperative conventional pelvic irradiation (60 Gy) vs no further treatment until relapse.
• Better define the selective pathologic indications for radiotherapy in patients with pT3 pN0 disease.

OUTLINE: This is a randomized study.

• Arm I: Patients undergo radiotherapy daily, 5 days a week, for 5 weeks, followed by boost radiotherapy for 1-1.4 weeks.
• Arm II: Patients are observed. Local relapse is treated with conventional pelvic radiotherapy. Patients are followed every 3 months during the first postoperative year, every 6 months until the fifth year, and annually thereafter.

PROJECTED ACCRUAL: A total of 1000 patients will be accrued for this study within 7.5 years.

Ages Eligible for Study:  up to  75 Years,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically documented invasive adenocarcinoma of the prostate staged pT3 pN0 after radical prostatectomy
• Preoperative staging must have been T1-3 N0 M0 based on physical exam, chest x-ray, bone scan, CT or MRI of entire pelvis and abdomen, and serum PSA
• At least 1 of the following features must be present:
• Complete capsule invasion (i.e., perforation)
• Positive surgical margins (microscopic or gross)
• Seminal vesicle invasion
• Radiotherapy must begin within 16 weeks following surgery, after recovery of urinary function

PATIENT CHARACTERISTICS: Age:

• 75 and under

Performance status:

• WHO 0-2

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

Other:

• No other malignancies

PRIOR CONCURRENT THERAPY: Biologic therapy:

• Not specified

Chemotherapy:

• Not specified

Endocrine therapy:

• No more than 4 months of preoperative hormonal therapy

Radiotherapy:

• Not specified

Surgery:

• Radical prostatectomy required within 12 weeks with recovery of urinary function

Belgium
      U.Z. Gasthuisberg, Leuven,  B-3000,  Belgium

Study chairs or principal investigators

Michel Bolla, MD,  Study Chair,  CHR de Grenoble - La Tronche   
Hein van Poppel, MD, PhD,  Study Chair,  U.Z. Gasthuisberg   

Study ID Numbers:  CDR0000078080; EORTC-22911; EORTC-GU-22911
Record last reviewed:  February 2005
Last Updated:  February 8, 2005
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002511
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08