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NCT00002511 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2012-10-16

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
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
healthy Volunteers
false
maximum Age
75 Years
sex
ALL
std Ages
  1. CHILD
  2. ADULT
  3. OLDER_ADULT
Treatment arms and interventions
interventions
  1. name
    low-LET photon therapy
    type
    RADIATION
Study design
primary Purpose
TREATMENT
Enrollment
count
1005
type
ACTUAL
Registered outcome plans (not posted results)
Full study description
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.
detailed Description
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.
Source references
references
  1. citation
    Ganswindt U, Stenzl A, Bamberg M, Belka C. Adjuvant radiotherapy for patients with locally advanced prostate cancer--a new standard? Eur Urol. 2008 Sep;54(3):528-42. doi: 10.1016/j.eururo.2008.06.059. Epub 2008 Jun 23.
    pmid
    18602742
    type
    BACKGROUND
  2. citation
    Gomella LG. Re: identification of patients with prostate cancer who benefit from immediate postoperative radiotherapy: EORTC 22911. Eur Urol. 2008 Apr;53(4):855-6. doi: 10.1016/j.eururo.2008.01.039.
    pmid
    18441534
    type
    BACKGROUND
  3. citation
    Graefen M. Words of wisdom. Re: Identification of patients with prostate cancer who benefit from immediate postoperative radiotherapy: EORTC 22911. Eur Urol. 2008 Mar;53(3):664-5. doi: 10.1016/j.eururo.2007.12.018. No abstract available.
    pmid
    18365318
    type
    BACKGROUND
  4. citation
    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.
    type
    RESULT
  5. citation
    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.
    type
    RESULT
  6. citation
    Bolla M, van Poppel H, Collette L, van Cangh P, Vekemans K, Da Pozzo L, de Reijke TM, Verbaeys A, Bosset JF, van Velthoven R, Marechal JM, Scalliet P, Haustermans K, Pierart M; European Organization for Research and Treatment of Cancer. Postoperative radiotherapy after radical prostatectomy: a randomised controlled trial (EORTC trial 22911). Lancet. 2005 Aug 13-19;366(9485):572-8. doi: 10.1016/S0140-6736(05)67101-2.
    pmid
    16099293
    type
    RESULT
  7. citation
    Davis JB, Reiner B, Dusserre A, Giraud JY, Bolla M; EORTC. Quality assurance of the EORTC trial 22911. A phase III study of post-operative external radiotherapy in pathological stage T3N0 prostatic carcinoma: the dummy run. Radiother Oncol. 2002 Jul;64(1):65-73. doi: 10.1016/s0167-8140(02)00143-3.
    pmid
    12208577
    type
    RESULT
  8. citation
    Bolla M, Van Poppel H, Collette L; au nom des groupes genito-urinaire et radiotherapie de l'EORTC. [Preliminary results for EORTC trial 22911: radical prostatectomy followed by postoperative radiotherapy in prostate cancers with a high risk of progression]. Cancer Radiother. 2007 Nov;11(6-7):363-9. doi: 10.1016/j.canrad.2007.09.001. Epub 2007 Oct 10. French.
    pmid
    17931949
    type
    RESULT
  9. citation
    Van der Kwast TH, Bolla M, Van Poppel H, Van Cangh P, Vekemans K, Da Pozzo L, Bosset JF, Kurth KH, Schroder FH, Collette L; EORTC 22911. Identification of patients with prostate cancer who benefit from immediate postoperative radiotherapy: EORTC 22911. J Clin Oncol. 2007 Sep 20;25(27):4178-86. doi: 10.1200/JCO.2006.10.4067.
    pmid
    17878474
    type
    RESULT
  10. citation
    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.
    type
    RESULT
  11. citation
    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.
    type
    RESULT
  12. citation
    van der Kwast TH, Collette L, Van Poppel H, Van Cangh P, Vekemans K, DaPozzo L, Bosset JF, Kurth KH, Schroder FH, Bolla M; European Organisation for Research and Treatment of Cancer Radiotherapy and Genito-Urinary Cancer Groups. Impact of pathology review of stage and margin status of radical prostatectomy specimens (EORTC trial 22911). Virchows Arch. 2006 Oct;449(4):428-34. doi: 10.1007/s00428-006-0254-x. Epub 2006 Aug 29.
    pmid
    16941153
    type
    RESULT
Source notices and limitations
    Discovery and provenance
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      occurrences
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      source title
      Prostate Cancer Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: May 14, 2025
        datetime
        2025-05-14T12:00:00Z
        display
        May 14, 2025

    Preserved source evidence · Not medical advice