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

Prostate Cancer Clinical Trial

Official title:

Phase III Randomized Study of Radiotherapy to the Prostate With or Without Radiotherapy to the Pelvis in Patients With Stage I, II, or III Adenocarcinoma of the Prostate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003607
• Other study ID #: CDR0000066684
• Secondary ID: FRE-FNCLCC-GETUG
• Status: Completed
• Phase: Phase 3
• First received: November 1, 1999
• Last updated: June 22, 2016
• Start date: December 1997
• Est. completion date: January 2015

Study information

• Verified date: June 2016
• Source: UNICANCER
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: January 2015
• Est. primary completion date: December 2002
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Radiation:
• radiation therapy

Locations

Country	Name	City	State
France	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 Saone
France	Centre Hospitalier Universitaire Henri Mondor	Creteil
France	Centre Oscar Lambret	Lille
France	Centre Hospital Regional Universitaire de Limoges	Limoges
France	Centre Leon Berard	Lyon
France	Clinique de la Sauvegarde	Lyon
France	Clinique de la Sauvegarde - Clinique Jeanne D'Arc	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	Orleans
France	Hopital d'Instruction des Armees du Val de Grace	Paris
France	Centre Hospitalier Lyon Sud	Pierre Benite
France	Institut Jean Godinot	Reims
France	Centre Eugene Marquis	Rennes
France	CHG Roanne	Roanne
France	Centre Paul Strauss	Strasbourg
France	Clinique de l'Orangerie	Strasbourg
France	Institut Claudius Regaud	Toulouse
France	Centre Marie Curie	Valance

Sponsors (1)

Lead Sponsor	Collaborator
UNICANCER

Country where clinical trial is conducted

France, 

References & 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? — View Citation

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