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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00002511
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : October 16, 2012
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

Brief Summary:

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 or disease Intervention/treatment Phase
Prostate Cancer Radiation: low-LET photon therapy Phase 3

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1005 participants
Primary Purpose: Treatment
Study Start Date : December 1992
Actual Primary Completion Date : December 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 75 and under

Performance status:

  • WHO 0-2


  • Not specified


  • Not specified


  • Not specified


  • No other malignancies


Biologic therapy:

  • Not specified


  • Not specified

Endocrine therapy:

  • No more than 4 months of preoperative hormonal therapy


  • Not specified


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002511

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U.Z. Gasthuisberg
Leuven, Belgium, B-3000
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
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Study Chair: Michel Bolla, MD CHU de Grenoble - Hopital de la Tronche
Study Chair: Hein van Poppel, MD, PhD University Hospital, Gasthuisberg
Publications of Results:
Bolla M, Van Poppel H, Van Cangh P, et al.: Does post-operative radiotherapy (P-RXT) after radical prostatectomy (Px) improve progression-free survival (PFS) in pT3N0 prostate cancer (PC)? (EORTC 22911). [Abstract] J Clin Oncol 22 (Suppl 14): A-4504, 383, 2004.
Bolla M, Van Poppel H, Van Cangh P, et al.: Post-operative radiotherapy (P-RXT) after radical prostatectomy (Px) improves progression-free survival (PFS) in pT3NO prostate cancer (PC) (EORTC 22911). [Abstract] Int J Radiat Oncol Biol Phys 60 (1 Suppl 1): A-93, S186, 2004. Available online. Last accessed January 27, 2005.
Tombal B, Scaillet P, Opsomer R, et al.: Immediate external beam radiation therapy (EBRT) after radical prostatectomy (PCa): long-term influence on QOL, urinary and rectal symptoms. [Abstract] American Urological Association: Annual Meeting, May 20-25, 2006, Atlanta, GA A-1599, 2006.
van der Kwast TH, Bolla M, van Poppel H, et al.: Gleason Score and margin status are the strongest predictors for benefit of radiotherapy after radical prostatectomy. [Abstract] American Urological Association: Annual Meeting, May 20-25, 2006, Atlanta, GA A-1391, 2006.

Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00002511    
Other Study ID Numbers: EORTC-22911
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: October 16, 2012
Last Verified: October 2012
Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
adenocarcinoma of the prostate
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases