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

NCT ID: NCT00003607

Last Updated: 2016-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 450 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1997-12-31
• Study Completion Date: 2015-01-31

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.

Detailed Description

OBJECTIVES:

• Compare the survival without recurrence and overall survival of patients with stage I, II, or III adenocarcinoma of the prostate after receiving radiotherapy to the prostate with or without radiotherapy to the pelvis.
• Compare the toxic effects of these two regimens in these patients.
• Compare the quality of life of patients treated with these regimens.
• Determine the prognostic factors of progression in these patients.
• Analyze the site of relapse (prostate, pelvic lymph nodes, metastases) in case of progression in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by participating center and prognostic group (poor vs good prognosis).

Patients are randomized to one of two treatment arms.

• Arm I: Patients receive pelvic irradiation plus local prostate irradiation.
• Arm II: Patients receive local prostate irradiation only. Radiotherapy in both arms is administered 5 days a week for 7 weeks.

Quality of life is assessed before therapy, 12 months after therapy, and then annually thereafter.

Patients are followed at 2 and 6 months and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 450 patients will be accrued for this study within 4 years.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT

Interventions

radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

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

• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

UNICANCER

OTHER

Sponsor Role: lead

Principal Investigators

Pascal Pommier, MD

Role: STUDY_CHAIR

Centre Leon Berard

Locations

Centre Paul Papin

Angers, , France

Centre Hospitalier d'Annecy

Annecy, , France

Institut Bergonie

Bordeaux, , France

Centre Regional Francois Baclesse

Caen, , France

Centre de Radiotherapie du Parc

Chalon-sur-Saône, , France

Centre Hospitalier Universitaire Henri Mondor

Créteil, , France

Centre Oscar Lambret

Lille, , France

Centre Hospital Regional Universitaire de Limoges

Limoges, , France

Clinique de la Sauvegarde - Clinique Jeanne D'Arc

Lyon, , France

Clinique de la Sauvegarde

Lyon, , France

Centre Leon Berard

Lyon, , France

Institut J. Paoli and I. Calmettes

Marseille, , France

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

Montpellier, , France

CHR D'Orleans - Hopital de la Source

Orléans, , France

Hopital d'Instruction des Armees du Val de Grace

Paris, , France

Centre Hospitalier Lyon Sud

Pierre-Bénite, , France

Institut Jean Godinot

Reims, , France

Centre Eugene Marquis

Rennes, , France

CHG Roanne

Roanne, , France

Clinique de l'Orangerie

Strasbourg, , France

Centre Paul Strauss

Strasbourg, , France

Institut Claudius Regaud

Toulouse, , France

Centre Marie Curie

Valance, , France

Countries

France

References

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.

Reference Type: RESULT

PMID: 18048817 (View on PubMed)

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.

Reference Type: RESULT

Other Identifiers

FRE-FNCLCC-GETUG-01

Identifier Type: -

Identifier Source: secondary_id

EU-98029

Identifier Type: -

Identifier Source: secondary_id

CDR0000066684

Identifier Type: -

Identifier Source: org_study_id