Search / Trial NCT00002511

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

Trial Information

Current as of December 26, 2024

Completed

Keywords

Adenocarcinoma Of The Prostate Stage I Prostate Cancer Stage Iib Prostate Cancer Stage Iia Prostate Cancer Stage Iii Prostate Cancer

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

Trial Officials

Michel Bolla, MD

Study Chair

CHU de Grenoble - Hopital de la Tronche

Hein van Poppel, MD, PhD

Study Chair

University Hospital, Gasthuisberg

About European Organisation For Research And Treatment Of Cancer Eortc

The European Organisation for Research and Treatment of Cancer (EORTC) is a prominent non-profit organization dedicated to advancing cancer research and improving patient care through innovative clinical trials. Established in 1962, EORTC fosters collaboration among international researchers, healthcare professionals, and institutions to develop and implement rigorous clinical studies that evaluate novel therapies and treatment strategies. With a strong commitment to enhancing the quality of life for cancer patients, EORTC focuses on multidisciplinary approaches and the integration of patient-reported outcomes, ensuring that its findings translate effectively into clinical practice and contribute to the global fight against cancer.

Locations

Leuven, , Belgium

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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