Radiation Therapy Compared With No Further Treatment Following Surgery in Treating Patients With Prostate Cancer

Launched by EUROPEAN ORGANISATION FOR RESEARCH AND TREATMENT OF CANCER - EORTC · Jan 26, 2003

Keywords

ClinConnect Summary

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 we...

Gender

ALL

Eligibility criteria

• DISEASE CHARACTERISTICS:
• • Histologically documented invasive adenocarcinoma of the prostate staged pT3 pN0 after radical prostatectomy
• • Preoperative staging must have been T0-3 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