Radiation Therapy in Treating Patients With Stage I, Stage II, or Stage III Prostate Cancer

NCT00003607 | Completed Phase 3

• 3 other identifiers: CDR0000066684FRE-FNCLCC-GETUG-01EU-98029
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 23

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether radiation therapy to the prostate and pelvis is more effective than radiation therapy to the prostate alone in treating prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy to the prostate with or without radiation to the pelvis in treating patients with stage I, stage II, or stage III prostate cancer.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; stage I prostate cancer; stage IIB prostate cancer; stage IIA prostate cancer; stage III prostate cancer

Interventions

radiation therapy RADIATION

Eligibility Criteria

• Age: Up to 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically proven adenocarcinoma of the prostate * Stage I (T1b or T1c, N0, M0) * Stage II (T2, N0, M0) * Stage III (T3, N0, M0) * Poor prognosis (high risk of lymph node invasion) defined as meeting at least 1 of the following criteria: * Gleason score at least 7 * Prostate-specific antigen (PSA) at least 3 times upper limit of normal (ULN) * T3 OR * Good prognosis defined as meeting 1 of the following criteria: * T1b or T2 * T1c with Gleason score less than 7 and PSA less than 3 times ULN * No metastases by bone scans or chest x-ray PATIENT CHARACTERISTICS: Age: * 75 and under Performance status: * Karnofsky 70-100% Life expectancy: * More than 10 years Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Other: * No other malignancy within the past 10 years except basal cell skin cancer * No adenopathies PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * At least 2-6 months since prior hormonal therapy, if duration no greater than 4-8 months * No concurrent luteinizing hormone-releasing hormone agonists * No concurrent anti-androgen therapy * No concurrent hormonal therapy in high-risk group Radiotherapy: * No prior pelvic radiotherapy Surgery: * No prior lymphadenectomy * No prior surgical castration * No prior prostatectomy * At least 1 month since prior transurethral resection

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

Sponsors & Collaborators

• UNICANCER: lead

Study Sites (23)

Centre Paul Papin

Angers, 49036, France

Location

Centre Hospitalier d'Annecy

Annecy, 74011 Cedex, France

Location

Institut Bergonie

Bordeaux, 33076, France

Location

Centre Regional Francois Baclesse

Caen, 14076, France

Location

Centre de Radiotherapie du Parc

Chalon-sur-Saône, 71100, France

Location

Centre Hospitalier Universitaire Henri Mondor

Créteil, 94010, France

Location

Centre Oscar Lambret

Lille, 59020, France

Location

Centre Hospital Regional Universitaire de Limoges

Limoges, 87042, France

Location

Clinique de la Sauvegarde - Clinique Jeanne D'Arc

Lyon, 69008, France

Location

Clinique de la Sauvegarde

Lyon, 69008, France

Location

Centre Leon Berard

Lyon, 69373, France

Location

Institut J. Paoli and I. Calmettes

Marseille, 13273, France

Location

Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

Montpellier, 34298, France

Location

CHR D'Orleans - Hopital de la Source

Orléans, 45067, France

Location

Hopital d'Instruction des Armees du Val de Grace

Paris, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

Institut Jean Godinot

Reims, 51056, France

Location

Centre Eugene Marquis

Rennes, 35064, France

Location

CHG Roanne

Roanne, F-42300, France

Location

Clinique de l'Orangerie

Strasbourg, 67010, France

Location

Centre Paul Strauss

Strasbourg, 67085, France

Location

Institut Claudius Regaud

Toulouse, 31052, France

Location

Centre Marie Curie

Valance, 26000, France

Location

Related Publications (2)

• Pommier P, Chabaud S, Lagrange JL, Richaud P, Lesaunier F, Le Prise E, Wagner JP, Hay MH, Beckendorf V, Suchaud JP, Pabot du Chatelard PM, Bernier V, Voirin N, Perol D, Carrie C. Is there a role for pelvic irradiation in localized prostate adenocarcinoma? Preliminary results of GETUG-01. J Clin Oncol. 2007 Dec 1;25(34):5366-73. doi: 10.1200/JCO.2006.10.5171.

  PMID: 18048817 RESULT

• Pommier P, Perol D, Lagrange J, et al.: Does pelvis and prostate radiation therapy compared to prostate radiation therapy alone improve survival in patients with non metastatic prostate carcinoma? Preliminary results of the prospective randomized GETUG 01 trial. [Abstract] Int J Radiat Oncol Biol Phys 63 (Suppl 1): A-33, S19, 2005.

  RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Pascal Pommier, MD

  Centre Leon Berard

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: December 1, 1997
• Primary Completion: December 1, 2002
• Study Completion: January 1, 2015
• Last Updated: June 23, 2016

Record last verified: 2016-06

Locations

FR (23)