NCT00002511

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,005

participants targeted

Target at P75+ for phase_3 prostate-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 1992

Completed
6.9 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2001

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

October 16, 2012

Status Verified

October 1, 2012

Enrollment Period

9 years

First QC Date

November 1, 1999

Last Update Submit

October 15, 2012

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostatestage I prostate cancerstage IIB prostate cancerstage IIA prostate cancerstage III prostate cancer

Interventions

low-LET photon therapyRADIATION

Eligibility Criteria

AgeUp to 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

Related Publications (15)

  • 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: 18602742BACKGROUND

  • 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: 18441534BACKGROUND

  • 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: 18365318BACKGROUND

  • 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.

    RESULT

  • 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.

    RESULT

  • 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: 16099293RESULT

  • 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: 12208577RESULT

  • 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: 17931949RESULT

  • 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: 17878474RESULT

  • 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.

    RESULT

  • 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.

    RESULT

  • 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: 16941153RESULT

  • Collette L, van Poppel H, Bolla M, van Cangh P, Vekemans K, Da Pozzo L, de Reijke TM, Verbaeys A, Bosset JF, Pierart M; European Organisation for Research and Treatment of Cancer (EORTC) Radiotherapy and Genito-urinary Groups. Patients at high risk of progression after radical prostatectomy: do they all benefit from immediate post-operative irradiation? (EORTC trial 22911). Eur J Cancer. 2005 Nov;41(17):2662-72. doi: 10.1016/j.ejca.2005.06.024. Epub 2005 Oct 11.

    PMID: 16223581RESULT

  • Ritter MA. Commentary on "Postoperative radiotherapy after radical prostatectomy for high-risk prostate cancer: long-term results of a randomised controlled trial (EORTC trial 22911)." Bolla M, van Poppel H, Tombal B, Vekemans K, Da Pozzo L, de Reijke TM, Verbaeys A, Bosset JF, van Velthoven R, Colombel M, van de Beek C, Verhagen P, van den Bergh A, Sternberg C, Gasser T, van Tienhoven G, Scalliet P, Haustermans K, Collette L; European Organisation for Research and Treatment of Cancer, Radiation Oncology and Genito-Urinary Groups. Department of Radiation Oncology, Centre Hospitalier Universitaire A Michallon, Grenoble, France.: Lancet 2012;380(9858):2018-27. doi: 10.1016/S0140-6736(12)61253-7. [Epub 2012 Oct 19]. Urol Oncol. 2014 Apr;32(3):372-3. doi: 10.1016/j.urolonc.2013.09.023.

    PMID: 24679462DERIVED

  • Bolla M, van Poppel H, Tombal B, Vekemans K, Da Pozzo L, de Reijke TM, Verbaeys A, Bosset JF, van Velthoven R, Colombel M, van de Beek C, Verhagen P, van den Bergh A, Sternberg C, Gasser T, van Tienhoven G, Scalliet P, Haustermans K, Collette L; European Organisation for Research and Treatment of Cancer, Radiation Oncology and Genito-Urinary Groups. Postoperative radiotherapy after radical prostatectomy for high-risk prostate cancer: long-term results of a randomised controlled trial (EORTC trial 22911). Lancet. 2012 Dec 8;380(9858):2018-27. doi: 10.1016/S0140-6736(12)61253-7. Epub 2012 Oct 19.

    PMID: 23084481DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Michel Bolla, MD

    CHU de Grenoble - Hopital de la Tronche

    STUDY CHAIR

  • Hein van Poppel, MD, PhD

    University Hospital, Gasthuisberg

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Purpose
TREATMENT
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

December 1, 1992

Primary Completion

December 1, 2001

Last Updated

October 16, 2012

Record last verified: 2012-10

Locations

BE(1)