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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00002511
First received: November 1, 1999
Last updated: October 15, 2012
Last verified: October 2012

November 1, 1999
October 15, 2012
December 1992
December 2001   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00002511 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Radiation Therapy Compared With No Further Treatment Following Surgery in Treating Patients With Prostate Cancer
PHASE III STUDY OF POST-OPERATIVE EXTERNAL RADIOTHERAPY IN PATHOLOGICAL STAGE T3 N0 PROSTATIC CARCINOMA

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.

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.

Interventional
Phase 3
Primary Purpose: Treatment
Prostate Cancer
Radiation: low-LET photon therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1005
Not Provided
December 2001   (final data collection date for primary outcome measure)

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
Both
up to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00002511
EORTC-22911, EORTC-22911, EORTC-GU-22911
Not Provided
European Organisation for Research and Treatment of Cancer - EORTC
European Organisation for Research and Treatment of Cancer - EORTC
Not Provided
Study Chair: Michel Bolla, MD CHU de Grenoble - Hopital de la Tronche
Study Chair: Hein van Poppel, MD, PhD U.Z. Gasthuisberg
European Organisation for Research and Treatment of Cancer - EORTC
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP